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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
Soterix Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Aphasia focused on measuring Stroke, Anomia

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    July 19, 2012
    Last Updated
    August 25, 2015
    Sponsor
    Soterix Medical
    Collaborators
    National Institute of Neurological Disorders and Stroke (NINDS)
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    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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