Hemiplegia, Stroke, Subcortical Infarction
Conditions
Keywords
Stroke, Transcranial magnetic stimulation, Rehabilitation, Neuronal plasticity, Subcortical infarction
Brief summary
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
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.
Interventions
DEVICELow-frequency rTMS (experimental)
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
DEVICELow-frequency rTMS (sham comparator)
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
Sponsors
Seoul National University Bundang Hospital
Chungnam National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
ALTMS-A
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Box and Block test | upto 42 days | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| National Institutes of Health Stroke Scale | upto 42 days | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS |
| Finger tapping | upto 42 days | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS |
| Box and Block test | upto 14 days | Before rTMS (baseline) and immediately after the completion of 10 sessions of rTMS |
| Fugl-Meyer Assessment Scale | upto 42 days | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS |
| Brunnstrom stage (hand and arm) | upto 42 days | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS |
| Modified Ashworth scale (wrist flexor, wrist extensor, elbow flexor, elbow extensor, and finger flexor) | upto 42 days | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS |
| Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck) | upto 42 days | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS |
| modified Barthel Index (the Korean version) | upto 42 days | Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS |
Other
| Measure | Time frame | Description |
|---|---|---|
| Vital sign | upto 42 days | Before rTMS (baseline), immediately after the completion of 10 sessions of rTMS, and 4 weeks after the completion of 10 sessions of rTMS |
Countries
South Korea
Outcome results
None listed