The treatment of brain-machine interface for post-stroke upper limb paralysis

JRCT ID: jRCTs042230092

Registered date:17/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: A patient with upper limb paralysis after a first stroke
• Date of first enrollment: 17/10/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Brain-machine interface therapy that activates external devices according to brain activity

Outcome(s)

• Primary Outcome: Amount of change from baseline in Fugl-Meyer Assessment (FMA) upper limb motor function item total score

Secondary Outcome

(1) Sub-items of FMA upper limb evaluation (each score from A to D)
(2) Motor Activity Log (MAL)
(3) Motor Score of Stroke Impairment Assessment Set (SIAS)
(4) Electromyogram of finger extensor and flexor muscles
(5) EEG during BMI treatment
(6) Modified Ashworth Scale (MAS)
(7) Functional Independence Measure (FIM)
(8) Total brain waves using high-density electroencephalograph and other electrophysiological tests
(9) Magnetic Resonance Imaging (MRI)
(10) Motor Evoked Potential (MEP)
(11) Kinematic evaluation (video, etc.)
(12) Box and Block test (BBT)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients for whom 10 days or more have passed since the onset of stroke
(2) Age 20 years or older
(3) Adult patients with upper limb paralysis after their first stroke who meet the following criteria:
(3)-1 Patients who have not lost deep sensation in the paralyzed finger
(3)-2 Patients whose range of motion in passive extension of the MP joint of the paralyzed finger is -10 degrees or more
(3)-3 Patients with severe to moderate motor function of the paralyzed hand (e.g. 40 points or less on the Fugl-Meyer Assessment)
(4) Patients who can give their own written consent. If the subject has sufficient ability to consent, but has difficulty writing due to paralysis or aphasia, confirm the subject's consent and obtain written consent from a surrogate writer.

Exclude criteria

(1) Patients for whom it is difficult to perform BMI. A specific example is below.
(1)-1 Serious heart disease
(1)-2 Uncontrolled hypertension
(1)-3 Complications of pulmonary embolism, acute cor pulmonale, or severe pulmonary hypertension within 90 days before the start of the study
(1)-4 Complications of severe liver/kidney dysfunction
(1)-5 Complications of serious orthopedic disease that impede movement
(1)-6 Severe cognitive impairment, comorbidity of severe mental illness
(1)-7 Patients who cannot wear a headset or electric orthosis
(1)-8Persons using a pacemaker or implantable defibrillator
(1)-9 People who have significant pain at the attachment site
(1)-10 People with febrile illness
(1)-11 People with skin sensitivity disorder
(1)-12 People who have difficulty attaching electrodes due to active skin disease (infectious diseases), etc.
(1)-13 Persons with malignant tumor or tuberculosis disease
(1)-14 People with severe spasticity or contracture
(1)-15 Pregnant women

Related Information

• Primary Sponsor: Ueki Yoshino
• Secondary Sponsor: LIFESCAPES Co Ltd