Stroke, Hemiplegia
Conditions
Keywords
Neuronal plasticity, Transcranial magnetic stimulation, Stroke, Upper extremity, Function, Recovery
Brief summary
The purpose of this study is to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper Extremity Motor Function Recovery in Patients with Ischemic Stroke
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) can modulate the excitability of cortex but exact efficacy and safety of rTMS is not well established. Eighty four patients will be recruited and will be divided into two groups. Each group will receive the real rTMS or sham rTMS, respectively, over the primary motor cortex of the dominant hand. Individual subject will receive ten sessions of rTMS. Each rTMS session is low frequency (1Hz), total 1800 stimulations. The purpose of this study is to evaluate efficacy and safety of rTMS 『TMS』 for upper extremity motor function recovery in patients with ischemic stroke.
Interventions
DEVICELow frequency rTMS
Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: tangential to scalp
Sponsors
DongGuk University
Seoul National University Hospital
REMED
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 20-80 yrs old * Radiologically confirmed ischemic stroke within 90 days * Brunnström stage 3-5 in the affected hand (ischemic stroke-induced hemiplegic side) * Patients received stroke treatment and on secondary prevention medication * Written informed consent
Exclusion criteria
* Previous medical histories of stroke, cerebral vascular operation, seizure * Pregnancy, Breastfeeding * Patients with hemorrhagic stroke, traumatic brain injury * Skin lesion in the stimulation site of scalp * Metal implants in the body (cardiac pacemaker or aneurysm clip) * Unable to have regular physical and occupational therapies on the affected hand
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Box and Block Test (affected hand) | up to 17 days | Before rTMS (baseline) and 10 days after the completion of 10 sessions of rTMS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Box and Block Test (Affected and unaffected hand) | up to 40 days | Before rTMS (baseline), 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start |
| Barthel Index | up to 40 days | 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start |
| National Institutes of Health Stroke Scale | up to 40 days | 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start |
| Fugl-Meyer Assessment Scale | up to 40 days | 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start |
| Finger tapping | up to 40 days | 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start |
| B-stage (hand and arm) | up to 40 days | 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start |
| Modified Ashworth scale (wrist flexor and extensor, Elbow flexor and extensor, Long finger flexor spasticity) | up to 40 days | 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start |
| Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck) | up to 40 days | 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start |
Other
| Measure | Time frame | Description |
|---|---|---|
| Vital Sign | up to 40 days | Before rTMS (baseline), 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start |
Countries
South Korea
Outcome results
None listed