europhysiological assessment of brain-machine interface

Phase 2

Recruiting

• Conditions: Stroke; Cerebrovascular disease

• Registration Number: JPRN-jRCTs032230542
• Lead Sponsor: Fujiwara Toshiyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-05
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment upper extremity score

Secondary Outcome Measures

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