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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Soterix Medical.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Soterix Medical
ClinicalTrials.gov Identifier:
NCT01651884
First received: July 19, 2012
Last updated: July 27, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by Soterix Medical:

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:
  • Soterix Medical High-Definition M x N stimulator
  • Soterix Medical HDTargets
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
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01651884

Sponsors and Collaborators
Soterix Medical
Investigators
Principal Investigator: Julius Fridriksson, PhD University of South Carolina
  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 September 14, 2014