Stroke (Cerebral Infarction,Intracerebral Hemorrhage,Subarachnoid Hemorrhage)
Conditions
Interventions
Brain-Machine Interface (BMI) therapy for 20 minutes/session, 5 sessions/week for 4 weeks (total 20 sessions) plus conventional rehabilitation
Conventional rehabilitation including electrical stimulat
Sponsors
Heisei Medical Welfare Group Research Institute
LIFESCAPES Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Stroke patients (hemorrhage, infarction, or subarachnoid hemorrhage) within 60 days of onset 2. Severe upper limb paresis: Passive extension range of motion >= -10 degrees at fingers' MP joints Initial FMA-UE (upper extremity motor function score) <= 30 3. Age >= 18 years 4. Capable of providing informed consent (for patients with motor aphasia, consent can be obtained by proxy after confirming patient's understanding using SLTA)
Exclusion criteria
Exclusion criteria: 1. Patients unable to undergo rehabilitation (neurological diseases, severe comorbidities, cognitive dysfunction [MMSE<21, except for motor aphasia], psychiatric disorders) 2. Patients with cardiac pacemaker or implantable cardioverter-defibrillator 3. Patients who participated in another clinical trial or clinical research within the year prior to participating in the research 4. Prior botulinum toxin therapy or nerve block before enrollment 5. Patients unable to undergo EEG measurement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) motor score at day 30 after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| FMA-UE subscales, sensory assessment (10-point scale), Modified Ashworth Scale, Functional Independence Measure, finger muscle EMG, EQ-5D-5L | — |
Countries
Japan
Contacts
Public ContactNoriko Kanasaki
Heisei Medical Welfare Group Research Institute Administrative division
Outcome results
None listed