tDCS and Aphasia Treatment

August 13, 2020 updated by: Elizabeth Galletta, PhD, Hunter College of City University of New York
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010
        • Hunter College Brookdale Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: single left hemisphere stroke, more than three months post stroke, right handed, no other medical problems, ages 18-100 -

Exclusion Criteria: more than one stroke, less than three months post stroke, other medical problems, pacemaker or other electronic implant (e.g. hip replacement), pregnancy

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: anodal tDCS
Soterix 1x1 device: anodal tDCS administered to the left hemisphere
Device: Soterix 1x1 tDCS
Anodal and sham tDCS will be administered. All of the participants will also receive behavioral speech-language therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in naming performance in singles words and sentence context
Time Frame: change from baseline naming performance at two weeks and four weeks post treatment
Naming will be tested using standardized tests such at the Boston Naming Test and or the Philadelphia Naming Test. In addition, sentence probes have been created that will assess naming in the sentence context throughout the study.
change from baseline naming performance at two weeks and four weeks post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in sentence production
Time Frame: change from baseline performance at two weeks and four weeks post treatment
Sentence production will be classified.
change from baseline performance at two weeks and four weeks post treatment
change in health related quality of life
Time Frame: change from baseline performance at two weeks and four weeks post treatment
Scales of health related quality of life will be implemented.
change from baseline performance at two weeks and four weeks post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunter College of City University of New York

Investigators

  • Principal Investigator: Elizabeth E Galletta, PhD, Hunter College/City University of NY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

August 2, 2013

First Submitted That Met QC Criteria

August 12, 2013

First Posted (ESTIMATE)

August 14, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2020

Last Update Submitted That Met QC Criteria

August 13, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 062951

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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