Effects of tDCS Versus HD-tDCS for Stroke Rehabilitation

Chronic Aphasia Clinical Trial

— tDCS- Aphasia  

Official title:

High Definition-transcranial Direct Current Stimulation (HD-tDCS) for Stroke Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651884
• Other study ID #: Pro00015784
• Secondary ID: 1R41NS076123-01
• Status: Completed
• Phase: Phase 1
• First received: July 19, 2012
• Last updated: August 25, 2015
• Start date: March 2012
• Est. completion date: January 2013

Study information

• Verified date: August 2015
• Source: Soterix Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Aphasia

Intervention

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
• Transcranial Direct Current Stimulation (Neuroconn)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Soterix Medical	National Institute of Neurological Disorders and Stroke (NINDS)