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Transcranial Direct Current Stimulation for Post-Stroke Aphasia

Primary Purpose

Stroke

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aphasia therapy
Anodal tDCS
Sham tDCS
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Adler Aphasia Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Anodal tDCS

Sham tDCS

Arm Description

Anodal tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions

Sham tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions

Outcomes

Primary Outcome Measures

Change in Percent Correct of Trained Scripts
Change in Words Per Minute of Trained Scripts

Secondary Outcome Measures

Change in Percent Correct of Trained Scripts
Change in Words Per Minute of Trained Scripts

Full Information

First Posted
April 8, 2015
Last Updated
April 17, 2019
Sponsor
Columbia University
Collaborators
Pitkin Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02461355
Brief Title
Transcranial Direct Current Stimulation for Post-Stroke Aphasia
Official Title
Enhancing Aphasia Therapy With Anodal Transcranial Direct Current Stimulation in Chronic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
Pitkin Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anodal tDCS
Arm Type
Experimental
Arm Description
Anodal tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Sham tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions
Intervention Type
Behavioral
Intervention Name(s)
Aphasia therapy
Intervention Description
Aphasia therapy using a computerized scripting program
Intervention Type
Device
Intervention Name(s)
Anodal tDCS
Intervention Description
Anodal transcranial direct current stimulation using the Chattanooga Ionto device
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
Sham transcranial direct current stimulation using the Chattanooga Ionto device
Primary Outcome Measure Information:
Title
Change in Percent Correct of Trained Scripts
Time Frame
From Baseline to up to 2 days post-training
Title
Change in Words Per Minute of Trained Scripts
Time Frame
From Baseline to up to 2 days post-training
Secondary Outcome Measure Information:
Title
Change in Percent Correct of Trained Scripts
Time Frame
Baseline to 2 weeks and 4 weeks post-training
Title
Change in Words Per Minute of Trained Scripts
Time Frame
Baseline to 2 weeks and 4 weeks post-training
Other Pre-specified Outcome Measures:
Title
Change in Percent Script Words Omitted
Time Frame
Baseline to immediate, 2 weeks, and 4 weeks post-training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age over 21 years Ischemic left hemispheric stroke verified by imaging (CT or MRI) greater than 6 months ago Residual non-fluent or anomic aphasia, with Western Aphasia Battery-Revised Aphasia Quotient score <60 Fluent English speaker prior to stroke Right-handed prior to stroke Ability to give informed consent and understand the tasks involved. Exclusion Criteria: History of recurrent stroke, either ischemic or hemorrhagic, in the left middle cerebral artery territory Imaging unavailable Large middle cerebral artery infarct involving entire inferior division (temporo-parietal) territory History of dementia prior to the stroke History of seizure, prior electroconvulsive therapy, deep brain stimulators, or brain surgery Social and/or personal circumstances that interfere with ability to return for therapy and assessment sessions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomoko Kitago, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adler Aphasia Center
City
Maywood
State/Province
New Jersey
ZIP/Postal Code
07607
Country
United States

12. IPD Sharing Statement

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Transcranial Direct Current Stimulation for Post-Stroke Aphasia

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