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Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01007136
First received: November 2, 2009
Last updated: May 29, 2015
Last verified: April 2015
November 2, 2009
May 29, 2015
March 2009
March 2014   (Final data collection date for primary outcome measure)
Upper Extremity Fugl-Meyer [ Time Frame: 2 weeks, 3 months and 1 year after stroke ]
Same as current
Complete list of historical versions of study NCT01007136 on ClinicalTrials.gov Archive Site
  • Jebsen Taylor Test [ Time Frame: 2 weeks, 3 months, 1 year after stroke ]
  • Wolf Motor Function Test [ Time Frame: 2 weeks 3 months 1 year after stroke ]
  • Medical Research Council grading scale [ Time Frame: 2 weeks, 3 months and 1 year after stroke ]
  • Barthel Index [ Time Frame: 2 weeks, 3 months and 1 year after stroke ]
  • Abilhand questionnaire [ Time Frame: 2 weeks, 3 months and 1 year after stroke ]
  • Ashworth Spasticity Scale [ Time Frame: 2 weeks, 3 months and 1 year after stroke ]
  • Beck Depression Inventory [ Time Frame: 2 weeks, 3 months and 1 year after stroke ]
  • Visual Analog Pain Scale [ Time Frame: Daily during therapy, 2 weeks, 3 months and 1 year after stroke ]
  • Mini Mental Status Scale [ Time Frame: 2 weeks, 3 months and 1 year after stroke ]
  • NIHSS [ Time Frame: 2 weeks, 3 months and 1 year after stroke ]
  • Motor Activity Log [ Time Frame: 2 weeks, 3 months and 1 year after stroke ]
  • fMRI overactivation in motor cortex: voxel count and intensity [ Time Frame: 2 weeks, 3 months and 1 year after stroke ]
Same as current
Not Provided
Not Provided
 
Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery
TDCS-enhanced Stroke Recovery and Cortical Reorganization
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ischemic Stroke
  • 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
  • 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.
  • 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.
    Intervention: Device: tDCS
  • 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.
    Intervention: Device: Sham tDCS
Hidler J, Hodics T, Xu B, Dobkin B, Cohen LG. MR compatible force sensing system for real-time monitoring of wrist moments during fMRI testing. J Neurosci Methods. 2006 Sep 15;155(2):300-7. Epub 2006 Feb 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01007136
082008-053
K23HD050267 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
University of Texas Southwestern Medical Center
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP