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Clinical Trials/NCT00792428
NCT00792428
Completed
Not Applicable

Facilitating Motor Recovery After Stroke Using tDCS

Beth Israel Deaconess Medical Center1 site in 1 country20 target enrollmentJune 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Beth Israel Deaconess Medical Center
Enrollment
20
Locations
1
Primary Endpoint
Fugl-Meyer Assessment of Upper Extremity Motor Impairment
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study is to determine whether a non-painful, non-invasive, brain-stimulation technique called transcranial direct current stimulation (tDCS) combined with traditional physical-occupational therapy (OT) will improve motor function in patients with chronic stroke. The aim is to determine the effect of applying real (anodal and/or cathodal) - in a dual configuration - vs sham (pretend) tDCS to the motor brain regions on both hemispheres - in a dual configuration - to improve motor function in chronic stroke patients. Our research in normal subjects has shown that motor skills can be enhanced if tDCS is applied to the brain's motor region during motor learning. The effects after a single session of tDCS can last for up to 30 minutes, effects of multiple sessions (one session per day) can last for weeks. Furthermore, single sessions of tDCS applied to the motor regions in stroke patients have shown that improvements in motor functions can be seen and that effects may last for at least 30 minutes. Patients enrolled in this trial will be randomized to receive either real tDCS or sham tDCS in combination with PT-OT once a day for 5 days. Assessments will be done about 3 days and 7 days after the end of the experimental treatment by investigators who are blinded to the intervention. Patients are also blinded as to whether they are receiving real or sham tDCS. We hypothesize that real tDCS applied to the motor regions in combination with PT-OT results in a subsequent improvement in motor function of the recovering hand over sham tDCS in combination with PT-OT.

Registry
clinicaltrials.gov
Start Date
June 2006
End Date
February 1, 2013
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gottfried Schlaug

Associate Professor of Neurology; Staff Neurologist

Beth Israel Deaconess Medical Center

Eligibility Criteria

Inclusion Criteria

  • First time clinical ischemic stroke or cerebrovascular accident
  • At least 5 months out from first ischemic stroke prior to study enrollment

Exclusion Criteria

  • More than 1 stroke (older strokes)
  • Significant pre-stroke disability
  • A terminal medical illness or disorder with survival of less than 1 year
  • Co-existent major neurological or psychiatric diseases (e.g., epilepsy)
  • Use of psychoactive drugs/medications - such as antidepressants,antipsychotic, stimulating agents
  • Active participation in other stroke recovery trials testing interventions

Outcomes

Primary Outcomes

Fugl-Meyer Assessment of Upper Extremity Motor Impairment

Time Frame: Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days

This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome.

Secondary Outcomes

  • Wolf-Motor-Function-Test(Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days)

Study Sites (1)

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