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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01651884
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : August 26, 2015
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Soterix Medical

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Aphasia Device: HD-tDCS (Soterix) Device: Transcranial Direct Current Stimulation (Neuroconn) Phase 1

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: High Definition-transcranial Direct Current Stimulation (HD-tDCS) for Stroke Rehabilitation
Study Start Date : March 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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:
  • Soterix Medical High-Definition M x N stimulator
  • Soterix Medical HDTargets

Experimental: Sponge tDCS Device: Transcranial Direct Current Stimulation (Neuroconn)
Other Name: Neuroconn

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01651884

Sponsors and Collaborators
Soterix Medical
National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: Julius Fridriksson, PhD University of South Carolina
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Responsible Party: Soterix Medical Identifier: NCT01651884    
Other Study ID Numbers: Pro00015784
1R41NS076123-01 ( U.S. NIH Grant/Contract )
First Posted: July 27, 2012    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015
Keywords provided by Soterix Medical:
Additional relevant MeSH terms:
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Nervous System Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations