Aphasia, Stroke
Conditions
Keywords
Aphasia, Stroke, functional Magnetic resonance imaging, fMRI, Language recovery after stroke, constraint induced aphasia therapy, CIAT, Repetitive transcranial magnetic stimulation, rTMS
Brief summary
In this study the investigators will examine the efficacy of navigated excitatory repetitive transcranial magnetic stimulation (nerTMS) for the treatment of post stroke aphasia. The investigators expect that this new types of rehabilitation (nerTMS) will help patients with aphasia return to their lives as they were prior to the stroke.
Detailed description
Aphasia after stroke is associated with high mortality, significant motor impairment, and severe limitations in social participation. During the past decade, therapies administered by stroke teams have made great strides to limit the motor impairments caused by stroke. Unfortunately, progress in aphasia rehabilitation has not experienced the same rapid advancement. This proposal is based on preliminary evidence from our recently completed pilot study which showed that navigated excitatory repetitive transcranial magnetic stimulation (nerTMS) targeted to residual activity in the affected hemisphere has a significant beneficial effect on post-stroke aphasia recovery.1 The main aim of this study is to conduct a double-blind, sham-controlled, dose-response nerTMS treatment trial in subjects with chronic aphasia. By conducting this comparative trial, we will provide clinical (qualitative and quantitative) and imaging evidence that nerTMS improves language function after stroke when compared to standard treatment (ST). The findings will have implications for patients with post-stroke aphasia in that once the study is completed and the results are available, rehabilitation specialists may be able to change their practice pattern by offering an additional tool to aid patients in recovering their language skills with improved participation in society and enhanced quality of life. To fill the gap in our therapeutic arsenal for aphasia, we propose a study with the following specific aims: (1) to determine the comparative efficacy and optimal dosing of nerTMS on aphasia recovery using a randomized, double-blind, sham-controlled study design. Subjects (15/group) will be randomly assigned to 4 treatment groups: (a) 3 weeks of nerTMS, (b) 1 week of ST + 2 weeks of nerTMS, (c) 2 weeks of ST +1 week of nerTMS, or (d) 3 weeks of ST (control group). This design will allow systematic evaluation of the efficacy of nerTMS and will determine its most optimal dose for language recovery. Short- and long-term outcomes will be evaluated with aphasia testing (AT) and fMRI; (2) to use fMRI to assess changes in language lateralization in response to nerTMS. We will examine the relationship between the degree of pre-nerTMS language lateralization (fMRI) with the post-nerTMS language outcomes (AT) and determine whether fMRI language lateralization can predict AT performance following nerTMS targeted to the left middle cerebral artery (LMCA) stroke areas.
Interventions
DEVICEMagstim SuperRapid
This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * LMCA stroke as indicated by the presence of aphasia and MRI lesion in the LMCA distribution * Moderate aphasia (Token Test score between 40th and 90th percentile) * Fluency in English * Provision of written informed consent by the patient and/or the next of kin
Exclusion criteria
* Age less than 18 years * Underlying degenerative or metabolic disorder or supervening medical illness * Severe depression or other psychiatric disorder * Positive pregnancy test in women of childbearing age * Any contraindication to MRI/fMRI at 3T (i.e., intracranial metal implants, claustrophobia) * Any contraindication to nerTMS (e.g., seizures or epilepsy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Aphasia Battery (WAB) - Long-Term Follow-Up | 3 months post treatment | WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild. |
| Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Long Term Follow-up | 3 months post treatment | 60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers. |
| Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Baseline | 1 week before the first nerTMS treatment | The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. Animals, Fruits) and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia. |
| Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Immediate Follow-up | within 1 week post treatment | The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. Animals, Fruits) and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia. |
| Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Long Term Follow-up | 3 months post treatment | The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. Animals, Fruits) and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia. |
| Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Baseline | 1 week before the first nerTMS treatment | The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. C, F, L) and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia. |
| Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Immediate Follow-up | within 1 week post treatment | The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. C, F, L) and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia. |
| Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Long Term Follow-up | 3 months post treatment | The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. C, F, L) and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia. |
| Western Aphasia Battery (WAB) - Baseline | Baseline: 1 week before the first nerTMS treatment | WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild. |
| Western Aphasia Battery (WAB) - Immediate Follow-Up | within 1 week post treatment | WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild. |
| Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Baseline | Baseline: 1 week before the first nerTMS treatment | 60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers. |
| Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Immediate Follow-Up | within 1 week post treatment | 60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Immediate Follow-up | within 1 week post treatment | Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB). |
| Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Long-term Follow Up | 3 months post treatment | Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB). |
| Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Baseline | Baseline: 1 week before the first nerTMS treatment | Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB). |
| Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Immediate Follow Up | within 1 week post treatment | Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB). |
| Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Long-term Follow Up | 3 months post treatment | Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB). |
| Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Baseline | Baseline: 1 week before the first nerTMS treatment | Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB). |
| Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Immediate Follow Up | within 1 week post treatment | Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB). |
| Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Long-term Follow Up | 3 months post treatment | Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB). |
| Change in Language Laterilazation as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Baseline | Baseline: 1 week before the first nerTMS treatment | Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| rTMS 3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery. | 7 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS 1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery. | 7 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS 2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery. | 7 |
| Control Group 3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery. | 7 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | rTMS | 1 Week of Sham Treatment + 2 Weeks of nerTMS | 2 Weeks of Sham Treatment +1 Week of nerTMS | Control Group | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 4 Participants | 0 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 3 Participants | 7 Participants | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 5 Participants | 4 Participants | 4 Participants | 18 Participants |
| Region of Enrollment India | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Region of Enrollment United States | 7 participants | 7 participants | 6 participants | 7 participants | 27 participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 3 Participants | 1 Participants | 8 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 4 Participants | 6 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 6 |
| other Total, other adverse events | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 6 |
Outcome results
Primary
Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Baseline
60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.
Time frame: Baseline: 1 week before the first nerTMS treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Baseline | 33.43 units on a scale | Standard Deviation 17.67 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Baseline | 18.29 units on a scale | Standard Deviation 18.94 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Baseline | 28.57 units on a scale | Standard Deviation 24.21 |
| Control Group | Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Baseline | 41.00 units on a scale | Standard Deviation 13.56 |
Primary
Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Immediate Follow-Up
60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.
Time frame: within 1 week post treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Immediate Follow-Up | 42.43 units on a scale | Standard Deviation 18.32 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Immediate Follow-Up | 24.86 units on a scale | Standard Deviation 22.23 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Immediate Follow-Up | 30.86 units on a scale | Standard Deviation 24.65 |
| Control Group | Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Immediate Follow-Up | 48.83 units on a scale | Standard Deviation 10.26 |
Comparison: paired t- test between time point 1 and time point 4 for the rTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.58.p-value: 0.006t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 4 for the1 week of Sham Treatment + 2 weeks of nerTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.27.p-value: 0.015t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment + 1 week of nerTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.p-value: 0.203t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 4 for the control group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.63.p-value: 0.01t-test, 2 sided
Primary
Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Long Term Follow-up
60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.
Time frame: 3 months post treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Long Term Follow-up | 38.50 units on a scale | Standard Deviation 20.44 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Long Term Follow-up | 15.67 units on a scale | Standard Deviation 17.69 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Long Term Follow-up | 25.17 units on a scale | Standard Deviation 24.69 |
| Control Group | Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Long Term Follow-up | 47.60 units on a scale | Standard Deviation 9.56 |
Comparison: paired t- test between time point 1 and time point 5 for the rTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.p-value: 0.41t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 5 for 1 week of Sham Treatment + 2 weeks of nerTMS group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.57.p-value: 0.618t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 5 for 2 weeks of Sham Treatment + 1 week of nerTMS group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 1.31.p-value: 1t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 5 for the control group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 4.35.p-value: 0.019t-test, 2 sided
Primary
Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Baseline
The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. C, F, L) and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.
Time frame: 1 week before the first nerTMS treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Baseline | 9.29 words generated | Standard Deviation 8.14 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Baseline | 4.43 words generated | Standard Deviation 6.24 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Baseline | 4.86 words generated | Standard Deviation 3.98 |
| Control Group | Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Baseline | 9.33 words generated | Standard Deviation 5.68 |
Primary
Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Immediate Follow-up
The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. C, F, L) and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.
Time frame: within 1 week post treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Immediate Follow-up | 12.43 words generated | Standard Deviation 10.13 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Immediate Follow-up | 5.43 words generated | Standard Deviation 5.53 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Immediate Follow-up | 5.00 words generated | Standard Deviation 5.35 |
| Control Group | Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Immediate Follow-up | 10.17 words generated | Standard Deviation 5.56 |
Comparison: paired t- test between time point 1 and time point 4 for the rTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.71.p-value: 0.109t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.28.p-value: 0.485t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.07.p-value: 0.864t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 4 for the control group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.43.p-value: 0.341t-test, 2 sided
Primary
Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Long Term Follow-up
The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. C, F, L) and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.
Time frame: 3 months post treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Long Term Follow-up | 9.67 words generated | Standard Deviation 8.38 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Long Term Follow-up | 3.33 words generated | Standard Deviation 4.18 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Long Term Follow-up | 4.67 words generated | Standard Deviation 5.47 |
| Control Group | Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Long Term Follow-up | 12.60 words generated | Standard Deviation 5.5 |
Comparison: paired t- test between time point 1 and time point 5 for the rTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.12.p-value: 0.899t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.19.p-value: 0.519t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.09.p-value: 1t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 5 for the control group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.84.p-value: 0.14t-test, 2 sided
Primary
Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Baseline
The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. Animals, Fruits) and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.
Time frame: 1 week before the first nerTMS treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Baseline | 16.29 words generated | Standard Deviation 13.01 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Baseline | 8.00 words generated | Standard Deviation 7.66 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Baseline | 9.57 words generated | Standard Deviation 9.03 |
| Control Group | Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Baseline | 25.50 words generated | Standard Deviation 8.92 |
Primary
Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Immediate Follow-up
The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. Animals, Fruits) and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.
Time frame: within 1 week post treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Immediate Follow-up | 18.86 units on a scale | Standard Deviation 13.43 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Immediate Follow-up | 8.86 units on a scale | Standard Deviation 8.76 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Immediate Follow-up | 11.14 units on a scale | Standard Deviation 10.11 |
| Control Group | Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Immediate Follow-up | 29.17 units on a scale | Standard Deviation 9.58 |
Comparison: paired t- test between time point 1 and time point 4 for the rTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.69.p-value: 0.118t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.28.p-value: 0.482t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.37.p-value: 0.368t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 4 for the control group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.70.p-value: 0.147t-test, 2 sided
Primary
Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Long Term Follow-up
The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. Animals, Fruits) and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.
Time frame: 3 months post treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Long Term Follow-up | 19.00 words generated | Standard Deviation 12.86 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Long Term Follow-up | 7.50 words generated | Standard Deviation 8.87 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Long Term Follow-up | 9.83 words generated | Standard Deviation 9.39 |
| Control Group | Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Long Term Follow-up | 30.40 words generated | Standard Deviation 5.32 |
Comparison: paired t- test between time point 1 and time point 5 for the rTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.p-value: 0.41t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.25.p-value: 0.695t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.25.p-value: 0.175t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 5 for the control group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.60.p-value: 0.518t-test, 2 sided
Primary
Western Aphasia Battery (WAB) - Baseline
WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.
Time frame: Baseline: 1 week before the first nerTMS treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Western Aphasia Battery (WAB) - Baseline | 64.214 units on a scale | Standard Deviation 33.201 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Western Aphasia Battery (WAB) - Baseline | 54.883 units on a scale | Standard Deviation 28.649 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Western Aphasia Battery (WAB) - Baseline | 54.380 units on a scale | Standard Deviation 27.405 |
| Control Group | Western Aphasia Battery (WAB) - Baseline | 81.740 units on a scale | Standard Deviation 13.639 |
Primary
Western Aphasia Battery (WAB) - Immediate Follow-Up
WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.
Time frame: within 1 week post treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Western Aphasia Battery (WAB) - Immediate Follow-Up | 63.500 units on a scale | Standard Deviation 36.559 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Western Aphasia Battery (WAB) - Immediate Follow-Up | 51.520 units on a scale | Standard Deviation 27.751 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Western Aphasia Battery (WAB) - Immediate Follow-Up | 57.460 units on a scale | Standard Deviation 28.076 |
| Control Group | Western Aphasia Battery (WAB) - Immediate Follow-Up | 77.700 units on a scale | Standard Deviation 12.895 |
Comparison: paired t- test between time point 1 and time point 4 for the control group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.67.p-value: 0.787t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 4 for the rTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.24.p-value: 0.52t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.97.p-value: 0.8t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.68.p-value: 0.148t-test, 2 sided
Primary
Western Aphasia Battery (WAB) - Long-Term Follow-Up
WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.
Time frame: 3 months post treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Western Aphasia Battery (WAB) - Long-Term Follow-Up | 72.417 units on a scale | Standard Deviation 31.692 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Western Aphasia Battery (WAB) - Long-Term Follow-Up | 50.560 units on a scale | Standard Deviation 27.219 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Western Aphasia Battery (WAB) - Long-Term Follow-Up | 61.960 units on a scale | Standard Deviation 31.587 |
| Control Group | Western Aphasia Battery (WAB) - Long-Term Follow-Up | 84.425 units on a scale | Standard Deviation 12.807 |
Comparison: paired t- test between time point 1 and time point 5 for the rTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -3.12.p-value: 0.239t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 2.71.p-value: 0.212t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -3.10.p-value: 0.12t-test, 2 sided
Comparison: paired t- test between time point 1 and time point 5 for the control group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.14.p-value: 0.263t-test, 2 sided
Secondary
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Baseline
Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).
Time frame: Baseline: 1 week before the first nerTMS treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Baseline | -0.24 index score | Standard Deviation 0.23 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Baseline | -0.05 index score | Standard Deviation 0.47 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Baseline | -0.09 index score | Standard Deviation 0.33 |
| Control Group | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Baseline | -0.23 index score | Standard Deviation 0.11 |
Secondary
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Immediate Follow Up
Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).
Time frame: within 1 week post treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Immediate Follow Up | 0.06 index score | Standard Deviation 0.26 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Immediate Follow Up | -0.22 index score | Standard Deviation 0.35 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Immediate Follow Up | 0.01 index score | Standard Deviation 0.39 |
| Control Group | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Immediate Follow Up | -0.33 index score | Standard Deviation 0.42 |
Secondary
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Long-term Follow Up
Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).
Time frame: 3 months post treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Long-term Follow Up | -0.08 index score | Standard Deviation 0.35 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Long-term Follow Up | 0.02 index score | Standard Deviation 0.21 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Long-term Follow Up | 0.08 index score | Standard Deviation 0.2 |
| Control Group | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Long-term Follow Up | -0.28 index score | Standard Deviation 0.21 |
Secondary
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Immediate Follow-up
Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).
Time frame: within 1 week post treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Immediate Follow-up | 0.02 index score | Standard Deviation 0.4 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Immediate Follow-up | 0.09 index score | Standard Deviation 0.46 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Immediate Follow-up | -0.09 index score | Standard Deviation 0.55 |
| Control Group | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Immediate Follow-up | -0.01 index score | Standard Deviation 0.39 |
Secondary
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Long-term Follow Up
Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).
Time frame: 3 months post treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Long-term Follow Up | 0.20 index score | Standard Deviation 0.41 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Long-term Follow Up | 0.20 index score | Standard Deviation 0.36 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Long-term Follow Up | 0.01 index score | Standard Deviation 0.69 |
| Control Group | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Long-term Follow Up | 0.20 index score | Standard Deviation 0.4 |
Secondary
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Baseline
Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).
Time frame: Baseline: 1 week before the first nerTMS treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Baseline | 0.14 index score | Standard Deviation 0.21 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Baseline | 0.15 index score | Standard Deviation 0.26 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Baseline | -0.19 index score | Standard Deviation 0.22 |
| Control Group | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Baseline | 0.10 index score | Standard Deviation 0.34 |
Secondary
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Immediate Follow Up
Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).
Time frame: within 1 week post treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Immediate Follow Up | 0.10 index score | Standard Deviation 0.31 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Immediate Follow Up | 0.06 index score | Standard Deviation 0.47 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Immediate Follow Up | -0.03 index score | Standard Deviation 0.46 |
| Control Group | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Immediate Follow Up | -0.03 index score | Standard Deviation 0.18 |
Secondary
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Long-term Follow Up
Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).
Time frame: 3 months post treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Long-term Follow Up | 0.21 index score | Standard Deviation 0.2 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Long-term Follow Up | -0.11 index score | Standard Deviation 0.14 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Long-term Follow Up | -0.02 index score | Standard Deviation 0.29 |
| Control Group | Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Long-term Follow Up | 0.23 index score | Standard Deviation 0.23 |
Secondary
Change in Language Laterilazation as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Baseline
Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).
Time frame: Baseline: 1 week before the first nerTMS treatment
Population: 1 participant from control group was unable to be analyzed due to loss of follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS | Change in Language Laterilazation as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Baseline | 0.30 Index score | Standard Deviation 0.4 |
| 1 Week of Sham Treatment + 2 Weeks of nerTMS | Change in Language Laterilazation as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Baseline | 0.22 Index score | Standard Deviation 0.2 |
| 2 Weeks of Sham Treatment +1 Week of nerTMS | Change in Language Laterilazation as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Baseline | -0.19 Index score | Standard Deviation 0.3 |
| Control Group | Change in Language Laterilazation as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Baseline | 0.13 Index score | Standard Deviation 0.42 |