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Efficacy of brain-machine interface training combined with botulinum toxin for severe hand paralysis after stroke - A single-blind randomized controlled trial -

Efficacy of brain-machine interface training combined with botulinum toxin for severe hand paralysis after stroke - A single-blind randomized controlled trial - - Efficacy of brain-machine interface training combined with botulinum toxin for severe hand paralysis after stroke - A single-blind randomized controlled trial -

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054364
Enrollment
20
Registered
2024-05-25
Start date
2024-05-31
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

Stroke

Interventions

Interventions (BMI group): Botulinum toxin plus BMI training. In BMI group, patients are provided with training using electroencephalogram-induced orthoses and electrical stimulators. Daily trainin

Sponsors

Nagoya City University Rehabilitation Hospital
Lead Sponsor
LIFESCAPES Inc.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) age between 20 to 80 years 2) time since stroke onset longer than 180 days 3) inability to extend the paretic finger after first stroke (Stroke Impairment Assessment Set (SIAS) < IB) 4) Modified Ashworth Scale (MAS) of Hand flexor muscle >= 1+ 5) Patients who are hospitalized after botulinum toxin to the hand flexor muscle

Exclusion criteria

Exclusion criteria: A patient who falls under the following; 1) subarachnoid hemorrhage 2) recurrent stroke 3) other neuromuscular disorders 4) severe spasticity or contracture of the fingers and are unable to extend or close the fingers passively (MAS >= 3) 5) phenomenon of forced grasp, apraxia, and unilateral spatial neglect 6) sever mental disorder (affects concentration and continuation of training) 7) cognitive deficits as determined by Mini mental state examination <= 23 8) significant hearing or visual impairment 9) Unable to attach the myoelectric electrode due to skin disease or difficult to wear the hand electric orthosis 10) serious hepatic, renal, cardiovascular, or respiratory disorders 11) Uncured malignancy 12) no history of seizures within the past 2 years

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Assessment(FMA) hand scale, Modified Ashworth Scale(MAS) of Hand flexor muscle

Secondary

MeasureTime frame
FMA upper limb score/sensory score for upper limb, Action Research Arm Test(ARAT), Motor Activity Log(MAL), Disability Assessment Scale(DAS), Visual Analogue Scale(VAS) for pain, Stroke Impact Scale(SIS)hand scale, Electroencephalography, surface electromyography, and evoked electromyography at rest and during attempts at finger extension

Countries

Japan

Contacts

Public ContactNaoya Anmoto

Nagoya City University Rehabilitation Hospital Division of Occupational Therapy, Department of Rehabilitation Medicine

naoya.am.708@gmail.com052-680-8123

Outcome results

None listed

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