Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation on the Recovery of Upper Motor Function After Stroke: a Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Seoul National University Bundang Hospital
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Change in the Fugl-Meyer Assessment scale (upper extremity)
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients.
Detailed Description
Repetitive transcranial magnetic stimulation (rTMS) can modulate excitability of the brain via non-invasive methods. In that sense, rTMS has been used to treat a variety of symptoms of stroke during last two decades. Especially, improvement of upper extremity function has been proved by many studies. However, it remains uncertain about the optimum amount of rTMS. The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients. Fifty-seven patients will be included with written consent. After randomization, the subject will receive 3 different amount of treatment rTMS-rTMS, Sham-rTMS, Sham-Sham) in double blind methods.
Investigators
Nam-Jong Paik
Professor
Seoul National University Bundang Hospital
Eligibility Criteria
Inclusion Criteria
- •single mono-hemispheric ischemic or hemorrhagic stroke
- •1st onset stroke patient
- •Upper extremity functional deficit attributable to acute stroke
- •A stage of at least 3 on brunnström pre-treatment
- •Written signed consent
Exclusion Criteria
- •Multiple lesion
- •Bilateral cortical lesion and motor problems
- •Cerebellar, or brainstem lesions
- •History of more than one stroke
- •Uncontrolled medical problems, such as: cardiopulmonary disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer, or renal disease;
- •Increased intracranial pressure
- •History of seizure confirmed by interview and medical chart review
- •Any individual who is on medication which is known to lower seizure threshold
- •Other conditions that increase the risk of side effects due to rTMS procedures: a metal plate or metal object in the skull or eye, intracardiac line, increased intracranial pressure, cardiac pacemaker, implanted medication pump, tricyclic antidepressants, neuroleptics, history of seizure in the immediate family
- •An age of less than 20 years old
Outcomes
Primary Outcomes
Change in the Fugl-Meyer Assessment scale (upper extremity)
Time Frame: Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up
Secondary Outcomes
- Change in grip strength, lateral pinch force, tip pinch force, Purdue pegboard test, K-MBI, mRS,and brunnström stage(Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up)