Effects of tDCS Versus HD-tDCS for Stroke Rehabilitation (tDCS- Aphasia)
Primary Purpose
Chronic Aphasia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
HD-tDCS (Soterix)
Transcranial Direct Current Stimulation (Neuroconn)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Aphasia focused on measuring Stroke, Anomia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High-Definition tDCS
Sponge tDCS
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01651884
First Posted
July 19, 2012
Last Updated
August 25, 2015
Sponsor
Soterix Medical
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT01651884
Brief Title
Effects of tDCS Versus HD-tDCS for Stroke Rehabilitation
Acronym
tDCS- Aphasia
Official Title
High Definition-transcranial Direct Current Stimulation (HD-tDCS) for Stroke Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soterix Medical
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Aphasia
Keywords
Stroke, Anomia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
High-Definition tDCS
Arm Type
Experimental
Arm Title
Sponge tDCS
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
HD-tDCS (Soterix)
Other Intervention Name(s)
Soterix Medical High-Definition M x N stimulator, Soterix Medical HDTargets
Intervention Description
Subjects will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation (Neuroconn)
Other Intervention Name(s)
Neuroconn
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julius Fridriksson, PhD
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effects of tDCS Versus HD-tDCS for Stroke Rehabilitation
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