tDCS and Aphasia Treatment

NCT ID: NCT01922245

Last Updated: 2020-08-14

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

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-01-31

Brief Summary

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This project will investigate the use of noninvasive brain stimulation in the form of tDCS (transcranial direct current stimulation) in conjunction with speech-language therapy, for the improvement of language production in stroke survivors with aphasia. The hypothesis is that anodal tDCS and speech-language therapy will facilitate improved outcomes compared to speech therapy alone.

Detailed Description

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Aphasia, commonly defined as impairment or loss of language functions, is a frequent and often chronic consequence of stroke, with detrimental effects on patient autonomy and health-related quality of life (HRQOL). Although beneficial in some cases, the effectiveness of behavioral therapy is often limited, and therefore new complementary treatments must be developed in order to improve rehabilitation of post-stroke aphasia.

In most individuals, language areas in the brain are localized in the left hemisphere. After stroke, there is evidence that the brain reorganizes such that either areas close to damaged language areas in the Left Hemisphere, or anatomically similar areas in the Right Hemisphere, are recruited to perform language tasks.

Recently, studies have begun to examine the effects of non-invasive brain stimulation on aphasia rehabilitation. One such technique is transcranial direct current stimulation (tDCS), which involves administering weak electrical currents through surface electrodes on the scalp. The effects can either stimulate an area, or inhibit an area of the brain. The main hypothesis is that stimulating language areas in the Left Hemisphere in conjunction with speech language therapy will facilitate reorganization of language-relevant areas of the brain, and improve expression.

The proposed study will compare the effects of transcranial direct current stimulation (tDCS) activating language centers in the Left Hemisphere and sham tDCS, in right-handed individuals with chronic post-stroke aphasia. This study will provide information on the effects of tDCS, in conjunction with speech-language therapy, on aphasia rehabilitation.

Conditions

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Aphasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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anodal tDCS

Soterix 1x1 device: anodal tDCS administered to the left hemisphere

Group Type EXPERIMENTAL

Soterix 1x1 tDCS

Intervention Type DEVICE

Anodal and sham tDCS will be administered. All of the participants will also receive behavioral speech-language therapy.

Interventions

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Soterix 1x1 tDCS

Anodal and sham tDCS will be administered. All of the participants will also receive behavioral speech-language therapy.

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hunter College of City University of New York

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Galletta, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth E Galletta, PhD

Role: PRINCIPAL_INVESTIGATOR

Hunter College/City University of NY

Locations

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Hunter College Brookdale Campus

New York, New York, United States

Site Status

Countries

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United States

References

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Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15.

Reference Type BACKGROUND
PMID: 20395612 (View on PubMed)

Fiori V, Cipollari S, Di Paola M, Razzano C, Caltagirone C, Marangolo P. tDCS stimulation segregates words in the brain: evidence from aphasia. Front Hum Neurosci. 2013 Jun 14;7:269. doi: 10.3389/fnhum.2013.00269. eCollection 2013.

Reference Type BACKGROUND
PMID: 23785323 (View on PubMed)

Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving aphasia in patients after stroke. Cochrane Database Syst Rev. 2013 Jun 25;(6):CD009760. doi: 10.1002/14651858.CD009760.pub2.

Reference Type RESULT
PMID: 23799617 (View on PubMed)

Other Identifiers

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062951

Identifier Type: -

Identifier Source: org_study_id

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