Using Transcranial Direct Current Stimulation (tDCS) to Improve Post-Stroke Aphasia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-09-30

Brief Summary

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This study tests whether weak electrical stimulation of the brain is effective in improving language or reading difficulties occurring after a brain injury or stroke.

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Detailed Description

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This study tests whether aphasia or alexia, language and reading disorders occurring after traumatic brain injury or stroke, can be improved using transcranial direct current stimulation (tDCS). tDCS is a non-invasive technique that applies a small amount of direct electrical current to the brain in order to temporarily alter brain processing. Adults with aphasia/alexia resulting from stroke or traumatic brain injury will undergo baseline behavioral testing of various language and cognitive functions. Subjects who are willing to undergo MRI evaluation will also be scanned. They will then receive five days of either real or sham tDCS with standardized speech-language therapy, under a double-blind randomized placebo-controlled design. Behavioral assessments, and MRIs for those participating in the MRI portion of the study, will be performed again at multiple time points after completing tDCS to assess for changes in these measures.

Conditions

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Aphasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Transcranial Direct Current Stimulation

TDCS was applied bilaterally, with the anodal electrode on the left temple and cathodal electrode on the right. TDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period

Group Type ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type DEVICE

The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.

Sham Stimulation

Sham tDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.

Group Type SHAM_COMPARATOR

Sham Stimulation

Intervention Type DEVICE

The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.

Interventions

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Transcranial Direct Current Stimulation

The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.

Intervention Type DEVICE

Sham Stimulation

The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 18 or older
* Aphasia due to left hemisphere stroke diagnosed by a physician or speech-language pathologist

Exclusion Criteria

* Skull defect at or near the site of tDCS delivery
* History of a significant stroke or traumatic brain injury other than the event that caused the aphasia
* History of other brain conditions that could impact interpretation of results (such as multiple sclerosis, brain tumor, encephalitis, premorbid dementia)
* Presence of implanted electrical or metallic devices in the head or body (except titanium; e.g. cochlear implants, implanted shunts with metal parts, deep brain stimulators, pacemakers, defibrillators)
* Presence of ferrous metal in the head (e.g. shrapnel)
* History of psychiatric disease requiring hospitalization, electroconvulsive therapy, or ongoing medication use (other than common selective serotonin reuptake inhibitor antidepressants)
* Pregnancy
* Severe comprehension deficits

* Presence of metal in the body (except titanium)
* Claustrophobia

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No