Effects of tDCS Versus HD-tDCS for Stroke Rehabilitation (tDCS- Aphasia)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Aphasia |
Device: HD-tDCS (Soterix) Device: Transcranial Direct Current Stimulation (Neuroconn) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | High Definition-transcranial Direct Current Stimulation (HD-tDCS) for Stroke Rehabilitation |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: High-Definition tDCS |
Device: HD-tDCS (Soterix)
Subjects will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets
Other Names:
|
| Experimental: Sponge tDCS |
Device: Transcranial Direct Current Stimulation (Neuroconn)
Other Name: Neuroconn
|
Eligibility| Ages Eligible for Study: | 25 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- one-time ischemic stroke in the left hemisphere
- greater than 6-months post-stroke onset
- between 25 and 80 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Soterix Medical |
| ClinicalTrials.gov Identifier: | NCT01651884 History of Changes |
| Other Study ID Numbers: | Pro00015784, 1R41NS076123-01 |
| Study First Received: | July 19, 2012 |
| Last Updated: | July 27, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Soterix Medical:
|
Stroke Anomia |
Additional relevant MeSH terms:
|
Aphasia Stroke Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013