The Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation for Upper-limb Motor Function Recovery in Subcortical and Brainstem Stroke

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of repetitive transcranial magnetic stimulation applied with an electromagnetic therapy stimulator 'ALTMS-A' for upper-limb motor function recovery with the sham control group for those who need upper-limb rehabilitation treatment for subcortical and brainstem stroke

Detailed Description
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After low-frequency repetitive transcranial magnetic stimulation (rTMS) over the contralesional motor cortex (M1), the score of the Box and Block test increased immediately, especially in patients without cortical involvement. Eighty-eight patients will be recruited and divided into two groups. Each group will receive 10 sessions of the real rTMS or sham rTMS over the contralesional primary motor cortex. Each rTMS session consists of low-frequency (1Hz) 1800 stimulations. The objective of this study is to evaluate the efficacy and safety of rTMS for upper-limb motor function in patients with subcortical and brainstem stroke.

Official Title
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Multi-center, Prospective, Comparative, Randomized, Double Blind, Superior, Pivotal Study to Compare and Evaluate the Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation Applied With an Electromagnetic Therapy Stimulator 'ALTMS-A' for Upper-limb Motor Function Recovery With the Sham Control Group for Those Who Need Upper-limb Rehabilitation Treatment for Subcortical and Brainstem Stroke (Ischemic)

Conditions
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Stroke, Hemiplegia, Subcortical Infarction

Intervention / Treatment
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* Device: Low-frequency rTMS (experimental)
* Device: Low-frequency rTMS (sham comparator)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19-80 years old Radiologically confirmed ischemic stroke with subcortical and brainstem lesions within 90 days Fugl-Meyer assessment scale (upper extremity) > 15 Mini-mental status exam (the Korean version) > 14 with appropriate cognitive function Written informed consent Exclusion Criteria: Fugl-Meyer assessment scale (wrist) < 1 or Fugl-Meyer assessment scale (hand) < 1 Hemorrhagic stroke or traumatic brain injury Cerebellar stroke Previous history of stroke Traumatic brain injury Previous history of brain surgery Need for intensive care due to complications associated with stroke (e.g. pneumonia, infection, hemodynamic instability) History of psychological or neurological diseases History of pain or muscular weakness of upper limbs which may interfere with rehabilitation History of seizure or epilepsy Aphasia Skin lesions in the stimulation site of scalp Intracranial metal implant Inability to receive regular physical or occupational therapy Disagreement to use contraception in women of childbearing age

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: real rTMS<br>Use the real rTMS coil | Device: Low-frequency rTMS (experimental)<br>* Frequency: Low-frequency (1Hz) rTMS / Intensity: 100% of resting motor threshold / Location: motor hotspot of the contralesional primary motor cortex (the first dorsal interosseous muscle) / Number of total stimuli : 1800 ; Coil orientation: tangential to scalp<br>|
| Sham Comparator: sham rTMS<br>Use the sham rTMS coil | Device: Low-frequency rTMS (sham comparator)<br>* Frequency: Low-frequency (1Hz) rTMS / Intensity: 100% of resting motor threshold / motor hotspot of the contralesional primary motor cortex (the first dorsal interosseous muscle) / Number of total stimuli : 1800 ; Coil orientation: vertical to scalp<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box and Block test | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS | upto 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box and Block test | Before rTMS (baseline) and immediately after the completion of 10 sessions of rTMS | upto 14 days | 
| Fugl-Meyer Assessment Scale | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS | upto 42 days | 
| modified Barthel Index (the Korean version) | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS | upto 42 days | 
| National Institutes of Health Stroke Scale | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS | upto 42 days | 
| Finger tapping | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS | upto 42 days | 
| Brunnstrom stage (hand and arm) | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS | upto 42 days | 
| Modified Ashworth scale (wrist flexor, wrist extensor, elbow flexor, elbow extensor, and finger flexor) | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS | upto 42 days | 
| Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck) | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS | upto 42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Stroke, Transcranial magnetic stimulation, Neuronal plasticity, Subcortical infarction