Aphasia
Conditions
Brief summary
Intensive therapy for aphasia has been demonstrated to improve language functioning after stroke or other neurological injury. However, recovery is generally not complete and new therapies are needed to improve outcomes. Transcranial direct current stimulation (tDCS) has been shown to improve outcomes with motor therapy after stroke. This study will examine the feasibility of using tDCS with intensive language therapy as a way of enhancing language outcomes in aphasia
Detailed description
Intensive therapy for aphasia has been demonstrated to improve language functioning after stroke or other neurological injury. However, recovery is generally not complete and new therapies are needed to improve outcomes. Transcranial direct current stimulation (tDCS) has been shown to improve outcomes with motor therapy after stroke. This study will examine the feasibility of using tDCS supplementing clinically determined intensive language therapy as a way of enhancing language outcomes in aphasia. Eligible clients enrolled in the University of Michigan Aphasia Program (UMAP) will be invited to participate in the study. Clients will receive 20 minutes of tDCS every day along with their usual treatment protocol. Pre and post testing will be completed to assess for improvement in language functioning. This is a feasibility and proof of concept study to determine if a randomized control trial should be pursued
Interventions
DEVICEtranscranial direct current stimulation
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All eligible participants with aphasia will receive the tDCS
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of aphasia * Enrolled in intensive therapy program at the University of Michigan Aphasia Program. * Ability to understand and give consent to treatment.
Exclusion criteria
* No metal implants or surgical devices * History of seizures * History of significant cognitive or psychiatric disturbance * Participant cannot be pregnant at the time of study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Controlled Oral Word Fluency | baseline and 4 weeks | This test assesses the number of words that can be generated in one minute that begin with certain letters. The total number of words generated for three letters is derived. Higher scores represent better performance. Changes in word fluency were calculated as follows: number of words generated post tDCS minus number of words generated pre tDCS |
| Change in Boston Naming Score | baseline and 4 weeks | This test assesses confrontational naming ability to 60 line drawings. Scores range from 0-60 with higher scores representing better performance. Outcome was derived as followed : Picture naming score post tDCS minus picture naming score pre tDCS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Western Aphasia Quotient Score | baseline and 4 weeks | severity of aphasia is measured by the Western Aphasia Battery Revised. The Aphasia Quotient (AQ) score ranges from 0-100, with 100 being a perfect score. Change in the AQ was derived as follows : AQ post tDCS minus AQ pre tDCS |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transcranial Direct Current Stimulation tDCS will be given to all qualified patients with aphasia.
transcranial direct current stimulation | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Transcranial Direct Current Stimulation | — |
|---|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 11.7 | — |
| Boston Naming Test | 5.94 units on a scale STANDARD_DEVIATION 5.97 | — |
| Controlled Oral Word Fluency | 14.74 number of words STANDARD_DEVIATION 10.27 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 18 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Change in Boston Naming Score
This test assesses confrontational naming ability to 60 line drawings. Scores range from 0-60 with higher scores representing better performance. Outcome was derived as followed : Picture naming score post tDCS minus picture naming score pre tDCS
Time frame: baseline and 4 weeks
Population: 23 of the 25 subjects completed the study and their data are analyzed here
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Change in Boston Naming Score | 1.25 score | Standard Deviation 3.96 |
Primary
Change in Controlled Oral Word Fluency
This test assesses the number of words that can be generated in one minute that begin with certain letters. The total number of words generated for three letters is derived. Higher scores represent better performance. Changes in word fluency were calculated as follows: number of words generated post tDCS minus number of words generated pre tDCS
Time frame: baseline and 4 weeks
Population: 23 of the participants completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Change in Controlled Oral Word Fluency | 3.1 number of words | Standard Deviation 4.89 |
Secondary
Change in Western Aphasia Quotient Score
severity of aphasia is measured by the Western Aphasia Battery Revised. The Aphasia Quotient (AQ) score ranges from 0-100, with 100 being a perfect score. Change in the AQ was derived as follows : AQ post tDCS minus AQ pre tDCS
Time frame: baseline and 4 weeks
Population: 23 subjects completed the study and their data were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Change in Western Aphasia Quotient Score | 8.57 aphasia quotient score | Standard Deviation 6.37 |