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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02461355
Other study ID # AAAO1700
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date June 2016

Study information

Verified date April 2019
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Aphasia therapy
Aphasia therapy using a computerized scripting program
Device:
Anodal tDCS
Anodal transcranial direct current stimulation using the Chattanooga Ionto device
Sham tDCS
Sham transcranial direct current stimulation using the Chattanooga Ionto device

Locations

Country Name City State
United States Adler Aphasia Center Maywood New Jersey

Sponsors (2)

Lead Sponsor Collaborator
Columbia University Pitkin Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Percent Script Words Omitted Baseline to immediate, 2 weeks, and 4 weeks post-training
Primary Change in Percent Correct of Trained Scripts From Baseline to up to 2 days post-training
Primary Change in Words Per Minute of Trained Scripts From Baseline to up to 2 days post-training
Secondary Change in Percent Correct of Trained Scripts Baseline to 2 weeks and 4 weeks post-training
Secondary Change in Words Per Minute of Trained Scripts Baseline to 2 weeks and 4 weeks post-training
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