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

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ClinicalTrials.gov Identifier: NCT01651884
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : August 26, 2015
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Soterix Medical

Study Description
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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

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01651884


Sponsors and Collaborators
Soterix Medical
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Julius Fridriksson, PhD University of South Carolina
More Information
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Responsible Party: Soterix Medical
ClinicalTrials.gov 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:
Stroke
Anomia
Additional relevant MeSH terms:
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Aphasia
Nervous System Diseases
Speech Disorders
Language Disorders
 Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations