Chronic Aphasia
Conditions
Keywords
Stroke, Anomia
Brief summary
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.
Interventions
DEVICEHD-tDCS (Soterix Medical, Active)
Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.
DEVICEHD-tDCS (Soterix Medical, Sham)
Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Georgetown University
University of North Carolina, Chapel Hill
The City College of New York
Medstar Health Research Institute
University of South Carolina
Soterix Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect size of HD-tDCS for the adjunctive treatment of anomia in chronic aphasia after stroke | 3 weeks | The primary outcome measures the ability of subjects to name objects in a standardized naming task. Prior to treatment MRI and fMRI are acquired to inform the individualized current flow models for optimal targeting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine alternate outcome measures | 4 weeks and 6 months follow up | Determine alternate outcome measures, such as naming performance at 4 weeks and 6 months after treatment and improvements in more general discourse performance. An additional secondary exploratory objective is to perform a screening comparison of HD-tDCS with historical data on conventional non-targeted tDCS using sponge electrodes. |
Countries
United States
Outcome results
None listed