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Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery

Not Applicable
Terminated
Conditions
Ischemic Stroke
Interventions
Device: tDCS
Device: Sham tDCS
Registration Number
NCT01007136
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
62
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
tDCS and occupational therapytDCS1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.
Sham and occupational therapySham tDCSElectric 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
NameTimeMethod
Upper Extremity Fugl-Meyer1 year after stroke

Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.

Secondary Outcome Measures
NameTimeMethod
Wolf Motor Function Test3 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.)

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center

🇺🇸

Dallas, Texas, United States

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