Effects of tDCS Versus HD-tDCS for Stroke Rehabilitation (tDCS- Aphasia)

Soterix Medical

Status and phase: Completed; Phase 1

Conditions: Chronic Aphasia

Treatments: Device: HD-tDCS (Soterix); Device: Transcranial Direct Current Stimulation (Neuroconn)

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT01651884

1R41NS076123-01 (U.S. NIH Grant/Contract)

Pro00015784

Details and patient eligibility

About

The purpose of this study is to assess the changes in language processing of patients with chronic aphasia after receiving non-invasive brain stimulation.Previous research using traditional transcranial direct current stimulation (tDCS) using 2 sponge electrodes has shown that persons with aphasia show more improvement after treatment when that treatment is accompanied by brain stimulation. Traditional tDCS has recently been modified to deliver current to more specific locations in the brain. This new delivery method is called high-definition tDCS (HD-tDCS). It is not known whether traditional tDCS (more diffuse current delivery) or HD-tDCS (more focal current delivery) will be the better approach for enhancing treatment outcomes. To answer this question, computerized speech-language treatment will be administered during the application of the different forms of brain stimulation.

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. one-time ischemic stroke in the left hemisphere
2. greater than 6-months post-stroke onset
3. between 25 and 80 years of age
4. aphasia diagnosis (as determined by pre-treatment language-based testing)
5. right-handed (before the stroke)
6. native speaker of English
7. ability to provide informed written or verbal consent

Exclusion criteria

1. clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems
2. factors contraindicative of tDCS administration (sensitive scalp, previous brain surgery)
3. prior history of epileptic or unprovoked seizures occurring during the previous 12 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 2 patient groups

High-Definition tDCS

Experimental group

Treatment:

Device: HD-tDCS (Soterix)

Sponge tDCS

Experimental group

Treatment:

Device: Transcranial Direct Current Stimulation (Neuroconn)