Primary Progressive Aphasia
Conditions
Keywords
Transcranial Direct Current Stimulation (tDCS)
Brief summary
The purpose of this study is to establish the feasibility of a program of remotely supervised transcranial direct current stimulation (RS-tDCS) paired with language skills practice for people living with the semantic or logopenic variants of primary progressive aphasia (PPA). There are currently no established standard-of-care treatments for PPA. This study will evaluate whether RS-tDCS combined with language skills practice is a feasible study design for individuals with PPA.
Interventions
tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through scalp sponge electrodes. The device is preprogrammed to ramp up to 2.0 mA (for 30 seconds), provide constant current throughout session (29 minutes), and then ramp down (for 30 seconds) at the end.
During each tDCS session, the tDCS clinician will guide the participant in a word-naming exercise. Participants will be presented with photos of target items and prompted to verbally produce the names of the pictures.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Primary progressive aphasia diagnosis (logopenic or semantic variant) 2. Peabody Picture Vocabulary Test (PPVT) score \< -1.0 SD, serving as a literacy proxy for premorbid cognitive ability and ensuring English language fluency sufficient for participation in the study procedures. 3. WAIS-IV Matrix Reasoning T score \< 20, serving as an index of current general cognitive functioning to exclude those with severe cognitive impairment 4. Stable and continuous access to internet service, email (WiFi hotspot to be provided if needed) 5. Fluent in English language (due to outcomes validated in English versions only)
Exclusion criteria
1. Disorder other than PPA known to cause language dysfunction 2. Diagnosis of nonfluent/agrammatic subtype of primary progressive aphasia 3. History of traumatic brain injury 4. Uncontrolled seizure disorder and/or recent (\<5 years) history of seizure 5. Metal implants in the head or neck 6. Any skin disorder or skin sensitive area near stimulation locations 7. Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Complete 16 Out of 20 Study Visits | Week 4 | Measure of feasibility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Untrained Language Probes at Treatment End | Week 4 | At baseline participants were shown photos of common items and assessed for spontaneous naming of each item. Thirty items were then selected for participants to be trained on, and 30 items served as the control word naming list. At study end, participants were assessed on their ability to spontaneously name the target words without the need for cueing. |
| Change in Aphasia Communication Outcome Measure (ACOM) Score | Baseline, Month 6 | Measurement of patient-reported communicative functioning in aphasia. Scores are presented as T-Scores that range from 0 to 100 with 50 representing the mean, with a standard deviation of ±10 indicating greater/less than average; higher T-scores indicate greater functional communication skills. |
| Change in Stroke and Aphasia Quality of Life-39 Item (SAQOL-39) Score | Baseline, Month 6 | 39-item assessment of quality of life among individuals with aphasia. Items are ranked on a Likert scale ranging from 1 (Couldn't do it at all) to 5 (No trouble at all). The total score is the average score of all items and ranges from 1 to 5; higher scores indicate greater quality of life. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Social Roles and Activities Score | Baseline, Month 6 | 35-item measurement of the perceived ability to perform one's usual social roles and activities. Each item is rated on a Likert scale ranging from 5 (never) to 1 (always). The raw score is the sum of responses and is converted to a T-score that has a population mean score of 50 with a standard deviation of 10; higher scores indicate greater ability to perform social roles and activities. |
| Number of Trained Language Probes at Treatment End | Week 4 | At baseline participants were shown photos of common items and assessed for spontaneous naming of each item. Thirty items were then selected for participants to be trained on, and 30 items served as the control word naming list. At study end, participants were assessed on their ability to spontaneously name the target words without the need for cueing. |
| Change in Quick Aphasia Battery (QAB) Score | Baseline, Month 6 | Assessment of language function. Includes eight subtests, each of which comprise sets of items that probe different language domains, vary in difficulty, and are scored with a graded system to maximize the informativeness of each item. The total scores range from 0 to 10, where: * 0.00-4.99 = Severe Aphasia * 5.00-7.49 = Moderate Aphasia * 7.50-8.89 = Mild Aphasia * 8.90-10.00 = No Aphasia |
| Change in Boston Naming Test (BNT)-Short Form Score | Baseline, Month 6 | Measures confrontational word retrieval in individuals with aphasia or other language disturbance. Consists of 15 line-drawn pictures presented in order of difficulty from easiest (e.g., house) to most difficult (e.g., palette). Participants have 20 seconds to name each item correctly with a cueing hierarchy. The total score is the sum of correct responses and ranges from 0 to 15; higher scores indicate greater confrontational word retrieval abilities. |
| Change in Controlled Oral Word Association Test (COWAT) Score | Baseline, Month 6 | The COWAT is verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter. The participants' task is to produce as many words as possible that begin with the given letter (F, A, or S) within a 1-minute time period. The total score is the total number of acceptable words produced for all three letters. The lowest possible score is zero, meaning no words could be produced. There is no limit to the higher end of the scale given that participants can produce as many words as possible for each of the three letters. Higher scores indicate greater word retrieval and better cognitive function. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health Score | Baseline, Month 6 | 10-item measurement of symptoms, functioning, and healthcare-related quality of life. The raw score is the sum of responses and is converted to a T-score that has a population mean score of 50 with a standard deviation of 10; higher scores indicate better QOL. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Remotely Supervised tDCS and Word-Naming Practice At each session, the tDCS device will deliver 2.0 mA electric current for 30 minutes over the left frontotemporal lobe with focus on the inferior frontal gyrus (IFG). Participants will receive 20 intervention sessions over the course of the interventional period (4 weeks) on weekdays (Monday-Friday). During the stimulation period, participants will engage in a picture-naming exercise as guided by the study tDCS clinicians.
Transcranial Direct Current Stimulation (tDCS): tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through scalp sponge electrodes. The device is preprogrammed to ramp up to 2.0 mA (for 30 seconds), provide constant current throughout session (29 minutes), and then ramp down (for 30 seconds) at the end.
Word-Naming Activity: During each tDCS session, the tDCS clinician will guide the participant in a word-naming exercise. Participants will be presented with photos of target items and prompted to verbally produce the names of the pictures. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Remotely Supervised tDCS and Word-Naming Practice |
|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 6.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Percentage of Participants Who Complete 16 Out of 20 Study Visits
Measure of feasibility.
Time frame: Week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remotely Supervised tDCS and Word-Naming Practice | Percentage of Participants Who Complete 16 Out of 20 Study Visits | 100 percentage of participants |
Change in Aphasia Communication Outcome Measure (ACOM) Score
Measurement of patient-reported communicative functioning in aphasia. Scores are presented as T-Scores that range from 0 to 100 with 50 representing the mean, with a standard deviation of ±10 indicating greater/less than average; higher T-scores indicate greater functional communication skills.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remotely Supervised tDCS and Word-Naming Practice | Change in Aphasia Communication Outcome Measure (ACOM) Score | 0.74 T-score | Standard Deviation 0.77 |
Change in Boston Naming Test (BNT)-Short Form Score
Measures confrontational word retrieval in individuals with aphasia or other language disturbance. Consists of 15 line-drawn pictures presented in order of difficulty from easiest (e.g., house) to most difficult (e.g., palette). Participants have 20 seconds to name each item correctly with a cueing hierarchy. The total score is the sum of correct responses and ranges from 0 to 15; higher scores indicate greater confrontational word retrieval abilities.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remotely Supervised tDCS and Word-Naming Practice | Change in Boston Naming Test (BNT)-Short Form Score | 1.6 score on a scale | Standard Deviation 0.37 |
Change in Controlled Oral Word Association Test (COWAT) Score
The COWAT is verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter. The participants' task is to produce as many words as possible that begin with the given letter (F, A, or S) within a 1-minute time period. The total score is the total number of acceptable words produced for all three letters. The lowest possible score is zero, meaning no words could be produced. There is no limit to the higher end of the scale given that participants can produce as many words as possible for each of the three letters. Higher scores indicate greater word retrieval and better cognitive function.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remotely Supervised tDCS and Word-Naming Practice | Change in Controlled Oral Word Association Test (COWAT) Score | 1.4 Correct words | Standard Deviation 2.23 |
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health Score
10-item measurement of symptoms, functioning, and healthcare-related quality of life. The raw score is the sum of responses and is converted to a T-score that has a population mean score of 50 with a standard deviation of 10; higher scores indicate better QOL.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remotely Supervised tDCS and Word-Naming Practice | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health Score | 0.87 T-score | Standard Deviation 0.89 |
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Social Roles and Activities Score
35-item measurement of the perceived ability to perform one's usual social roles and activities. Each item is rated on a Likert scale ranging from 5 (never) to 1 (always). The raw score is the sum of responses and is converted to a T-score that has a population mean score of 50 with a standard deviation of 10; higher scores indicate greater ability to perform social roles and activities.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remotely Supervised tDCS and Word-Naming Practice | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Social Roles and Activities Score | -1.2 T-score | Standard Deviation 3.48 |
Change in Quick Aphasia Battery (QAB) Score
Assessment of language function. Includes eight subtests, each of which comprise sets of items that probe different language domains, vary in difficulty, and are scored with a graded system to maximize the informativeness of each item. The total scores range from 0 to 10, where: * 0.00-4.99 = Severe Aphasia * 5.00-7.49 = Moderate Aphasia * 7.50-8.89 = Mild Aphasia * 8.90-10.00 = No Aphasia
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remotely Supervised tDCS and Word-Naming Practice | Change in Quick Aphasia Battery (QAB) Score | 0.14 score on a scale | Standard Deviation 0.31 |
Change in Stroke and Aphasia Quality of Life-39 Item (SAQOL-39) Score
39-item assessment of quality of life among individuals with aphasia. Items are ranked on a Likert scale ranging from 1 (Couldn't do it at all) to 5 (No trouble at all). The total score is the average score of all items and ranges from 1 to 5; higher scores indicate greater quality of life.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remotely Supervised tDCS and Word-Naming Practice | Change in Stroke and Aphasia Quality of Life-39 Item (SAQOL-39) Score | -0.07 score on a scale | Standard Deviation 0.2 |
Number of Trained Language Probes at Treatment End
At baseline participants were shown photos of common items and assessed for spontaneous naming of each item. Thirty items were then selected for participants to be trained on, and 30 items served as the control word naming list. At study end, participants were assessed on their ability to spontaneously name the target words without the need for cueing.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remotely Supervised tDCS and Word-Naming Practice | Number of Trained Language Probes at Treatment End | 25.1 Number of Trained Language Probes | Standard Deviation 4.33 |
Number of Untrained Language Probes at Treatment End
At baseline participants were shown photos of common items and assessed for spontaneous naming of each item. Thirty items were then selected for participants to be trained on, and 30 items served as the control word naming list. At study end, participants were assessed on their ability to spontaneously name the target words without the need for cueing.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remotely Supervised tDCS and Word-Naming Practice | Number of Untrained Language Probes at Treatment End | 20.2 Number of Untrained Language Probes | Standard Deviation 7.07 |