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Transcranial Direct Current Stimulation for Post-Stroke Aphasia

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ClinicalTrials.gov Identifier: NCT02461355
Recruitment Status : Terminated (Poor recruitment)
First Posted : June 3, 2015
Last Update Posted : June 17, 2016
Sponsor:
Collaborator:
Pitkin Foundation
Information provided by (Responsible Party):
Tomoko Kitago, Columbia University

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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Aphasia therapy Device: Anodal tDCS Device: Sham tDCS Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Aphasia Therapy With Anodal Transcranial Direct Current Stimulation in Chronic Stroke Patients
Study Start Date : June 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

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




Primary Outcome Measures :
  1. Change in percent correct of trained scripts [ Time Frame: From Baseline to up to 2 days post-training ]
  2. Change in words per minute of trained scripts [ Time Frame: From Baseline to up to 2 days post-training ]

Secondary Outcome Measures :
  1. Change in percent correct of trained scripts [ Time Frame: Baseline to 2 weeks and 4 weeks post-training ]
  2. Change in words per minute of trained scripts [ Time Frame: Baseline to 2 weeks and 4 weeks post-training ]

Other Outcome Measures:
  1. Change in percent script words omitted [ Time Frame: Baseline to immediate, 2 weeks, and 4 weeks post-training ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461355


Locations
United States, New Jersey
Adler Aphasia Center
Maywood, New Jersey, United States, 07607
Sponsors and Collaborators
Columbia University
Pitkin Foundation
Investigators
Principal Investigator: Tomoko Kitago, MD Columbia University

Responsible Party: Tomoko Kitago, Assistant Professor of Neurology, Columbia University
ClinicalTrials.gov Identifier: NCT02461355     History of Changes
Other Study ID Numbers: AAAO1700
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Stroke
Aphasia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms