Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Texas Southwestern Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01007136
First received: November 2, 2009
Last updated: December 11, 2013
Last verified: December 2013

November 2, 2009
December 11, 2013
March 2009
April 2014   (final data collection date for primary outcome measure)
Upper Extremity Fugl-Meyer [ Time Frame: 2 weeks, 3 months and 1 year after stroke ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Wolf Motor Function Test [ Time Frame: 2 weeks 3 months 1 year after stroke ] [ Designated as safety issue: No ]
  • Medical Research Council grading scale [ Time Frame: 2 weeks, 3 months and 1 year after stroke ] [ Designated as safety issue: No ]
  • Barthel Index [ Time Frame: 2 weeks, 3 months and 1 year after stroke ] [ Designated as safety issue: No ]
  • Abilhand questionnaire [ Time Frame: 2 weeks, 3 months and 1 year after stroke ] [ Designated as safety issue: No ]
  • Ashworth Spasticity Scale [ Time Frame: 2 weeks, 3 months and 1 year after stroke ] [ Designated as safety issue: No ]
  • Beck Depression Inventory [ Time Frame: 2 weeks, 3 months and 1 year after stroke ] [ Designated as safety issue: No ]
  • Visual Analog Pain Scale [ Time Frame: Daily during therapy, 2 weeks, 3 months and 1 year after stroke ] [ Designated as safety issue: Yes ]
  • Mini Mental Status Scale [ Time Frame: 2 weeks, 3 months and 1 year after stroke ] [ Designated as safety issue: Yes ]
  • NIHSS [ Time Frame: 2 weeks, 3 months and 1 year after stroke ] [ Designated as safety issue: Yes ]
  • Motor Activity Log [ Time Frame: 2 weeks, 3 months and 1 year after stroke ] [ Designated as safety issue: No ]
  • fMRI overactivation in motor cortex: voxel count and intensity [ Time Frame: 2 weeks, 3 months and 1 year after stroke ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
 
Recruiting
150
April 2014
April 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
Both
18 Years to 80 Years
Yes
Contact: Timea Hodics, M.D. 214-648-7843 Timea.Hodics@UTSouthwestern.edu
Contact: Charlotte Bentley 214-648-7843 Charlotte.Bentley@UTSouthwestern.edu
United States
 
NCT01007136
082008-053, K23HD050267
Yes
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
December 2013

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