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Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01007136
Recruitment Status : Terminated (Funding limit reached due to slower then anticipated recruitment.)
First Posted : November 3, 2009
Results First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Timea Hodics, University of Texas Southwestern Medical Center

Brief Summary:
The purpose is to determine whether application of a non-invasive battery powered device called transcranial direct current stimulation (tDCS) can improve recovery of hand weakness after stroke beyond what is achievable with rehabilitative treatment alone.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Device: tDCS Device: Sham tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: TDCS-enhanced Stroke Recovery and Cortical Reorganization
Study Start Date : March 2009
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: tDCS and occupational therapy
1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.
Device: tDCS
1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.
Other Names:
  • Transcranial Direct Current Stimulation
  • Electric stimulation

Sham Comparator: Sham and occupational therapy
Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
Device: Sham tDCS
Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.




Primary Outcome Measures :
  1. Upper Extremity Fugl-Meyer [ Time Frame: 2 weeks ]
    Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.

  2. Upper Extremity Fugl-Meyer [ Time Frame: 3 months ]
    Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.

  3. Upper Extremity Fugl-Meyer [ Time Frame: 1 year after stroke ]
    Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.


Secondary Outcome Measures :
  1. Wolf Motor Function Test [ Time Frame: 3 months ]

    The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability determined through the use of timed and functional tasks. The score represents the average speed the subject could perform of the timed motor tasks.

    The score is the average of the scores calculated from "how many times would a person have completed the task, had he or she been performing it continuously for 60 seconds". The score ranges from 0 to no theoretical maximum, with higher numbers meaning faster/ better performance. (See publication Dr. Hodics et al. 2012.)



Other Outcome Measures:
  1. Visual Analog Pain Scale [ Time Frame: during therapy ]
  2. Mini Mental Status Scale [ Time Frame: 3 months ]
    Mini Mental Status Scale is a test of cognitive function; it includes tests of orientation, attention, memory, language and visual-spatial skills, scored 0-30, the higher scores mean the better performance.

  3. NIHSS [ Time Frame: 3 months ]
    The National Institutes of Health Stroke Scale (NIHSS) provides a quantitative measure of stroke-related neurologic deficit. The NIHSS was originally designed as a research tool to measure baseline data on patients in acute stroke clinical trials. The score ranges 0-42, a score of 0 represents no deficit, lower score is better.

  4. Beck Depression Inventory [ Time Frame: 3 months ]
    21-item, self-rated scale that evaluates key symptoms of depression. The minimum score is 0 and maximum score is 63. Higher scores indicate greater symptom severity.

  5. Ashworth Spasticity Scale [ Time Frame: 3 months ]
  6. Abilhand Questionnaire [ Time Frame: 3 months ]
  7. Motor Activity Log [ Time Frame: 3 months ]
  8. fMRI Overactivation in Motor Cortex: Voxel Count and Intensity [ Time Frame: 3 months ]
  9. Barthel Index [ Time Frame: 3 months ]
    The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living. Ten variables describing activities of daily living and mobility are scored. The total score ranges 0-100, a higher number being a reflection of greater ability to function independently following hospital discharge.

  10. Medical Research Council (MRC) Scale [ Time Frame: 3 months ]
    The muscle scale grades muscle strength on a scale of 0 to 5 in relation to the maximum expected for that muscle. The patient's effort is graded on a scale of 0 (no movement) -5 (muscle contracts normally against full resistance).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ischemic stroke causing arm weakness within 5-15 days
  • no other neurological or psychiatric disease, who are able to perform study tasks

Exclusion Criteria:

  • patients younger than 18 or older than 80 years
  • patients with more than one disabling stroke
  • Patients with bilateral motor impairment
  • Patients with poor motivational capacity, history of severe alcohol or drug abuse
  • Patients with severe language disturbances, particularly of receptive nature
  • Patients with serious cognitive deficits (defined as equivalent to a MMS score of 23 or less)
  • Patients with severe uncontrolled medical problems (e.g., seizures, progressive stroke syndromes, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age or others),
  • Patients with unstable thyroid disease
  • Patients with increased intracranial pressure
  • Patients with unstable cardiac arrhythmia
  • Patients with contraindication to TMS or tDCS stimulation (pacemaker, an implanted medication pump, a metal plate in the skull, or metal objects inside the eye or skull, patients who had a craniotomy, skin lesions at the site of stimulation)
  • Patients who are not available for follow-up at 3 and 12 months
  • Pregnancy
  • Patients with contraindication to MRI will not participate in MRI

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): NCT01007136


Locations
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United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Publications:
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Responsible Party: Timea Hodics, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01007136    
Other Study ID Numbers: STU 092010-231
K23HD050267 ( U.S. NIH Grant/Contract )
First Posted: November 3, 2009    Key Record Dates
Results First Posted: September 22, 2020
Last Update Posted: September 22, 2020
Last Verified: September 2020
Keywords provided by Timea Hodics, University of Texas Southwestern Medical Center:
tDCS
stroke
functional MRI
TMS
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases