Transcranial Direct Current Stimulation for Post-Stroke Aphasia

NCT ID: NCT02461355

Last Updated: 2019-05-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Anodal tDCS

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

Group Type EXPERIMENTAL

Aphasia therapy

Intervention Type BEHAVIORAL

Aphasia therapy using a computerized scripting program

Anodal tDCS

Intervention Type DEVICE

Anodal transcranial direct current stimulation using the Chattanooga Ionto device

Sham tDCS

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

Group Type SHAM_COMPARATOR

Aphasia therapy

Intervention Type BEHAVIORAL

Aphasia therapy using a computerized scripting program

Sham tDCS

Intervention Type DEVICE

Sham transcranial direct current stimulation using the Chattanooga Ionto device

Interventions

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Aphasia therapy

Aphasia therapy using a computerized scripting program

Intervention Type BEHAVIORAL

Anodal tDCS

Anodal transcranial direct current stimulation using the Chattanooga Ionto device

Intervention Type DEVICE

Sham tDCS

Sham transcranial direct current stimulation using the Chattanooga Ionto device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pitkin Foundation

UNKNOWN

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tomoko Kitago, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Adler Aphasia Center

Maywood, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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AAAO1700

Identifier Type: -

Identifier Source: org_study_id

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