Effects of tDCS Versus HD-tDCS for Stroke Rehabilitation

NCT ID: NCT01651884

Last Updated: 2015-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Aphasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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High-Definition tDCS

Group Type EXPERIMENTAL

HD-tDCS (Soterix)

Intervention Type DEVICE

Subjects will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets

Sponge tDCS

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation (Neuroconn)

Intervention Type DEVICE

Interventions

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HD-tDCS (Soterix)

Subjects will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets

Intervention Type DEVICE

Transcranial Direct Current Stimulation (Neuroconn)

Intervention Type DEVICE

Other Intervention Names

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Soterix Medical High-Definition M x N stimulator Soterix Medical HDTargets Neuroconn

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Soterix Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julius Fridriksson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Other Identifiers

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1R41NS076123-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00015784

Identifier Type: -

Identifier Source: org_study_id

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