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
  Purpose

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 Intervention Phase
Ischemic Stroke
Device: tDCS
Device: Sham tDCS
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: TDCS-enhanced Stroke Recovery and Cortical Reorganization

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Upper Extremity Fugl-Meyer [ Time Frame: 2 weeks, 3 months and 1 year after stroke ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: March 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007136

Contacts
Contact: Timea Hodics, M.D. 214-648-7843 Timea.Hodics@UTSouthwestern.edu
Contact: Charlotte Bentley 214-648-7843 Charlotte.Bentley@UTSouthwestern.edu

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Timea Hodics, M.D.    214-648-7843    Timea.Hodics@UTSouthwestern.edu   
Principal Investigator: Timea Hodics, M.D.         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
  More Information

Publications:
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01007136     History of Changes
Other Study ID Numbers: 082008-053, K23HD050267
Study First Received: November 2, 2009
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
tDCS
stroke
functional MRI
TMS

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014