Targeted Electrotherapy for Aphasia Stroke Rehabilitation (TEASER) - Phase II Multi-Center Study

Study Overview
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Brief Summary
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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.

Official Title
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Targeted Transcranial Electrotherapy for Stroke Rehabilitation - Exploratory Trial on Aphasia

Conditions
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Chronic Aphasia

Intervention / Treatment
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* Device: HD-tDCS (Soterix Medical, Active)
* Device: HD-tDCS (Soterix Medical, Sham)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-Definition tDCS (Active)<br> | Device: HD-tDCS (Soterix Medical, Active)<br>* Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.<br>* Other names: Soterix Medical HDTargets;|
| Experimental: High-Definition tDCS (Sham)<br> | Device: HD-tDCS (Soterix Medical, Sham)<br>* Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.<br>* Other names: Soterix Medical HDTargets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect size of HD-tDCS for the adjunctive treatment of anomia in chronic aphasia after stroke | 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. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine alternate outcome measures | 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. | 4 weeks and 6 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Anomia