Transcranial Direct Current Stimulation for Post-Stroke Aphasia

April 17, 2019 updated by: Columbia University

Enhancing Aphasia Therapy With Anodal Transcranial Direct Current Stimulation in Chronic Stroke Patients

This is a randomized, crossover design trial that will compare how anodal transcranial direct current stimulation (tDCS) versus sham tDCS administered during multiple sessions of scripting therapy affects the acquisition and retention of trained scripts.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

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 Jersey
      • Maywood, New Jersey, United States, 07607
        • Adler Aphasia Center

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age over 21 years
  2. Ischemic left hemispheric stroke verified by imaging (CT or MRI) greater than 6 months ago
  3. Residual non-fluent or anomic aphasia, with Western Aphasia Battery-Revised Aphasia Quotient score <60
  4. Fluent English speaker prior to stroke
  5. Right-handed prior to stroke
  6. Ability to give informed consent and understand the tasks involved.

Exclusion Criteria:

  1. History of recurrent stroke, either ischemic or hemorrhagic, in the left middle cerebral artery territory
  2. Imaging unavailable
  3. Large middle cerebral artery infarct involving entire inferior division (temporo-parietal) territory
  4. History of dementia prior to the stroke
  5. History of seizure, prior electroconvulsive therapy, deep brain stimulators, or brain surgery
  6. Social and/or personal circumstances that interfere with ability to return for therapy and assessment sessions.

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anodal tDCS
Anodal tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions
Behavioral: Aphasia therapy
Aphasia therapy using a computerized scripting program
Device: Anodal tDCS
Anodal transcranial direct current stimulation using the Chattanooga Ionto device
Sham Comparator: Sham tDCS
Sham tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions
Behavioral: Aphasia therapy
Aphasia therapy using a computerized scripting program
Device: Sham tDCS
Sham transcranial direct current stimulation using the Chattanooga Ionto device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Percent Correct of Trained Scripts
Time Frame: From Baseline to up to 2 days post-training
From Baseline to up to 2 days post-training
Change in Words Per Minute of Trained Scripts
Time Frame: From Baseline to up to 2 days post-training
From Baseline to up to 2 days post-training

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Percent Correct of Trained Scripts
Time Frame: Baseline to 2 weeks and 4 weeks post-training
Baseline to 2 weeks and 4 weeks post-training
Change in Words Per Minute of Trained Scripts
Time Frame: Baseline to 2 weeks and 4 weeks post-training
Baseline to 2 weeks and 4 weeks post-training

Other Outcome Measures

Outcome Measure
Time Frame
Change in Percent Script Words Omitted
Time Frame: Baseline to immediate, 2 weeks, and 4 weeks post-training
Baseline to immediate, 2 weeks, and 4 weeks post-training

Collaborators and Investigators

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

Sponsor

Columbia University

Collaborators

Pitkin Foundation

Investigators

  • Principal Investigator: Tomoko Kitago, MD, Columbia University

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

June 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

June 2, 2015

First Posted (Estimate)

June 3, 2015

Study Record Updates

Last Update Posted (Actual)

May 9, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAO1700

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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