Targeted Electrotherapy for Aphasia Stroke Rehabilitation (TEASER) - Phase II Multi-Center Study
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 25 - 75 |
| Updated: | 4/6/2019 |
| Start Date: | July 2015 |
| End Date: | September 2019 |
| Contact: | Abhishek Datta, Ph.D |
| Email: | contact@soterixmedical.com |
| Phone: | 888-990-8327 |
Targeted Transcranial Electrotherapy for Stroke Rehabilitation - Exploratory Trial on Aphasia
This Phase II study aims to ascertain the effectiveness of HD-tDCS for adjunctive treatment
of anomia in chronic aphasia post stroke. Furthermore, it will help explore factors such as
alternate outcome measures, subject selection criteria, and benefits of extended treatment
duration. These results will be compared to an existing trial using conventional non-targeted
tDCS with the same design and outcomes. Patients will be treated with HD-tDCS while
performing computerized anomia treatment. The basis behind this method is that language
therapy is mediated by cortical areas that are most effectively activated during the training
tasks, thus increasing electric stimulation in these areas may improve learning outcomes. To
better understand the long term benefits of the adjunctive treatment, patients will be
screened again four weeks and six months after study using the same anomia tests. If HD-tDCS
shows promising results in increasing the learning outcomes of anomia treatment, a Phase III
trial can be considered.
of anomia in chronic aphasia post stroke. Furthermore, it will help explore factors such as
alternate outcome measures, subject selection criteria, and benefits of extended treatment
duration. These results will be compared to an existing trial using conventional non-targeted
tDCS with the same design and outcomes. Patients will be treated with HD-tDCS while
performing computerized anomia treatment. The basis behind this method is that language
therapy is mediated by cortical areas that are most effectively activated during the training
tasks, thus increasing electric stimulation in these areas may improve learning outcomes. To
better understand the long term benefits of the adjunctive treatment, patients will be
screened again four weeks and six months after study using the same anomia tests. If HD-tDCS
shows promising results in increasing the learning outcomes of anomia treatment, a Phase III
trial can be considered.
Inclusion Criteria:
- one-time ischemic stroke in the left hemisphere
- greater than 6-months post-stroke onset
- between 25 and 75 years of age
- aphasia diagnosis (as determined by pre-treatment language-based testing)
- right-handed (before the stroke)
- native speaker of English
- ability to provide informed written or verbal consent
Exclusion Criteria:
- clinically reported history of dementia, alcohol abuse, psychiatric disorder,
traumatic brain injury, or extensive visual acuity or visual-spatial problems
- factors contraindicative of tDCS administration (sensitive scalp, previous brain
surgery)
- prior history of epileptic or unprovoked seizures occurring during the previous 12
months.
- Presence of Metal implants of claustrophobia (not able to undergo MRI)
- Pregnancy
- Presence of any other neurological disease than stroke
- Childhood history of speech, language, hearing, or intellectual impairment
We found this trial at
2
sites
Chapel Hill, North Carolina 27514
Phone: 919-843-3699
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Washington, District of Columbia 20057
Phone: 202-877-1124
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