Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation on the Recovery of Upper Motor Function After Stroke: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Change in the Fugl-Meyer Assessment scale (upper extremity)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Any current actively treated medical or surgical condition or neurological or psychiatric illness other than stroke
- •Complications that would prevent participation in the intervention, such as severe pain and severe spasticity
- •Inability to cooperate outcome measure-related task
- •Severe language disturbances
- •Serious cognitive deficits
- •Non-vascular cause for the neurological symptoms other central nervous system
- •Disorder or peripheral neuropathy of the upper extremity
- •Taking medication which interrupt brain activity
- •Women who are pregnant
Arms & Interventions
Real rTMS-Real rTMS
Real rTMS for 2 weeks
Intervention: repetitive transcranial magnetic stimulation (rTMS) (Device)
Sham rTMS-Sham rTMS
Sham rTMS for 2 weeks
Intervention: repetitive transcranial magnetic stimulation (rTMS) (Device)
Sham rTMS-Real rTMS
Sham rTMS in the first week and real rTMS in the second week
Intervention: repetitive transcranial magnetic stimulation (rTMS) (Device)
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)
Investigators
Nam-Jong Paik
Professor
Seoul National University Bundang Hospital