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Effectiveness and safety evaluation of electroencephalography-based brain machine interface rehabilitation system (PN-S3219010) for patients with severe hemiparetic stroke: a randomized clinical trial for regulatory approval.

Effectiveness and safety evaluation of electroencephalography-based brain machine interface rehabilitation system (PN-S3219010) for patients with severe hemiparetic stroke: a randomized clinical trial for regulatory approval. - The BEST-BRAIN trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026372
Enrollment
40
Registered
2017-03-02
Start date
2017-03-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe hemiparatic stroke

Interventions

BMI group: BMI training and conventional occupational therapy Control group: motor imagery training and conventional occupational therapy Control group: motor imagery training and conventional occupa

Sponsors

Department of rehabilitation medicine,Keio University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 time from stroke onset longer than 90 days 2 first ever stroke patients satisfied all criteria indicated below a. proprioceptive sensory score on SIAS is more than 1 b knee-mouth test sore on SIAS is more than 2 c passive range of motion is minus 10 degrees for metacarpophalangeal joint extension d finger test score on SIAS is 1A 3 ability to walk independently in daily life with or without assistance 4 ability to understand and consent the study protocol by himself

Exclusion criteria

Exclusion criteria: 1.serious medical conditions for rehabilitation indicated below a. severe heart disease b. uncontrolled hypertension c. history of pulmonary embolism, acute pulmonary heart disease, or severe pulmonary hypertension within 90 days before enrollment d. severe hepatic or renal dysfunction e. severe orthopedic impairment f. severe cognitive or psychiatric disorder g. other serious medical conditions 2. pacemaker or other implanted stimulator use 3. history of seizures within 90 days before enrollment 4. participation of other clinical trial for regulatory approval within 90 days before enrollment 5.receiving other special neurorehabilitation technique for upper extremity paresis, such as trans cranial magnetic stimulation, therapeutic electrical stimulation, constraint induced movement therapy, and repetitive facilitative exercise, within 90 days before enrollment 6. injection of botulinum toxin or phenol for treatment of upper limb spasticity within 90 days before enrollment 7. impossible to record electroencephalography because of skin status or skull deformity 8. other critical problems to participate the study

Design outcomes

Primary

MeasureTime frame
Change between baseline and 4 weeks after the end of the therapy of Fugl-Meyer Assessment upper extremity motor score(FMA)

Secondary

MeasureTime frame
1. Sub-scales of FMA 2. Barthel Index 3. Motor Activity Log 4. Stroke Impairment Assessment Set 5. Goal Attainment Scaling 6. electromyography of finger extensor muscles 7. electroencephalography during BMI training 8. MAS 9. SS-QOL 10. ARAT

Countries

Japan

Contacts

Public ContactKimiko Tsuchiya

Keio University Hospital Department of rehabilitation medicine

ktsuchiya@keio.jp03-5363-3833

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026