Neurophysiological assessment of brain-machine interface

JRCT ID: jRCTs032230542

Registered date:05/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Stroke
• Date of first enrollment: 05/01/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Upper extremity rehabilitation with BMI for 40 minutes

Outcome(s)

• Primary Outcome: Fugl-Meyer Assessment upper extremity score

Secondary Outcome

Motor activity Log-14 (amount of use) (MAL-14 AOU)
Modified Ashworth scale (finger, wrist, elbow)
SIAS finger function test
Surface EMG
Reciprocal Inhibition in paretic upper extremity
Motor Evoked Potential (MEP) by transcranial magnetic stimulation
Magnetic Resonance Imaging (MRI)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1. 18 and more years old, and less than 80years old.
2. First ever stroke patients satisfied all criteria indicated below:
2.1. No loss of deep sensation
2.2. Passive range of motion is minus 10 degrees for metacarpophalangeal joint extension
3. Witten informed consent

Exclude criteria

1. Serious medical conditions for rehabilitation indicated below:
1.1. Severe heart disease
1.2. Uncontrolled hypertension
1.3. History of pulmonary embolism, acute pulmonary heart disease, or severe pulmonary hypertension within 90 days before enrollment
1.4. Severe hepatic or renal dysfunction
1.5. Severe orthopedic impairment
1.6. Severe cognitive or psychiatric disorder
1.7. Patients not eligible for medical devices
1.8. Other serious medical conditions
2. Other critical problems to participate the study

Related Information

• Primary Sponsor: Fujiwara Toshiyuki
• Source(s) of Monetary Support: LIFESCAPES