Individualized rTMS for Motor Recovery in Stroke Patients
- Conditions
- StrokeTranscranial Magnetic Stimulation
- Interventions
- Device: Repetitive transcranial magnetic stimulation
- Registration Number
- NCT05914038
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
This study aimed to aim to investigate the efficacy of individualized rTMS according to lateralization index on motor recovery and cortical excitability in subacute stroke patients.
- Detailed Description
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology.
High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode.
However, the current rTMS studies for stroke patients utilized the same therapeutic protocol and there is no individualized rTMS protocol based on the value of lateralization index.
This study aimed to aim to investigate the efficacy of individualized rTMS according to lateralization index on motor recovery and cortical excitability in subacute stroke patients.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Unilateral ischemic or hemorrhagic stroke
- Stroke within 3 months
- Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
- No previous stroke, seizure, dementia, Parkinson's disease or other degenerative neurological diseases.
- Patient could sit over 15 minutes
- Age over 20
- Previous stroke, traumatic brain injury, brain tumor
- With central nervous system disease (spinal cord injury, Parkinson's disease)
- Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker)
- Patients unable to cooperate the treatment
- Pregnancy
- Depression
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description individualized rTMS Repetitive transcranial magnetic stimulation Patients will receive individualized repetitive transcranial magnetic stimulation according to lateralization index measured by functional near-infrared spectroscopy Traditional rTMS Repetitive transcranial magnetic stimulation Control group is given traditional rTMS
- Primary Outcome Measures
Name Time Method Fugl-Meyer Assessment 12 weeks post intervention Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.
- Secondary Outcome Measures
Name Time Method Barthel Index 1 week, 4 weeks, 12 weeks post intervention Barthel Index, score 100-0. Higher scores indicate a better outcome.
MEP 1 week, 4 weeks, 12 weeks post intervention motor evoked potential
Fugl-Meyer Assessment 1 week, 4 weeks post intervention Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.
National Institutes of Health Stroke Scale 1 week, 4 weeks, 12 weeks post intervention National Institutes of Health Stroke Scale, The maximum possible score is 42, with the minimum score being a 0. Higher scores indicate a worse outcome.
Modified Rankin Scale 1 week, 4 weeks, 12 weeks post intervention Modified Rankin Scale, score from 0 to 6. Higher scores indicate a worse outcome.
functional NIRS 1 week, 4 weeks, 12 weeks post intervention Functional Near Infrared Spectroscopy to detect the cortical excitability
Medical Research Council (MRC) Scale for Muscle Strength 1 week, 4 weeks, 12 weeks post intervention Medical Research Council (MRC) Scale for Muscle Strength, assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction).
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei county, Taipei, Taiwan