A Prospective, Randomized, Parallel-Controlled Clinical Study Protocol of Non-Invasive Brain Computer Interface Robot Based on Mirror Rehabilitation Theory in the Treatment of Upper Limb Motor Function Disorder After Stroke
Trial ID: NCT07553416
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-05-01
Completion date: 2027-12-31
Sponsor: Beijing Tiantan Hospital
Conditions: Ischemic Stroke; Intracranial Haemorrhage; Brain-Computer Interfaces; Rehabilitation Exercise
Interventions: Brain computer interface-robotic mirror therapy
Locations: Beijing Tiantan Hospital, Capital Medical University
Countries: China
Enrollment: 40
Age range: 30 Years - 80 Years
Sex: ALL

Summary:
This study aims to utilize non-invasive brain-computer interface technology in conjunction with mirror therapy to design a new paradigm for rehabilitation robots to induce compensatory movements on the healthy side in stroke patients, evaluate the potential rehabilitation value of this paradigm for patients with severely impaired motor areas on the affected side, explore the neural rehabilitation compensation mechanism, and provide more personalized rehabilitation treatment strategies for patients with post-stroke motor dysfunction.

Eligibility criteria:
Inclusion Criteria:

1. Aged 30 to 80 years
2. Patients with unilateral upper limb motor dysfunction caused by primary ischemic/hemorrhagic stroke within 1 to 6 months prior to enrollment
3. Cerebral magnetic resonance diffusion-weighted imaging (DWI) at the time of onset indicating that the stroke lesion is limited to the unilateral basal ganglia region
4. Modified Rankin Scale (mRS) score of 0 to 2 before stroke onset
5. Fugl-Meyer Motor Function Assessment of Upper Extremities (FMA-UE) score of 10 to 42
6. Montreal Cognitive Assessment (MoCA) score \> 18
7. Fugl-Meyer Balance Assessment score \> 6
8. Normal binocular visual acuity or corrected visual acuity
9. Normal hearing and intact verbal comprehension ability
10. Provided written informed consent

Exclusion Criteria:

1. Patients with other severe cardiovascular and cerebrovascular diseases and unstable vital signs
2. Patients with motor dysfunction caused by other etiologies, such as amyotrophic lateral sclerosis, myasthenia gravis, muscular dystrophy, hypokalemic periodic paralysis, spondylitis, arthritis, osteomyelitis, etc.
3. Patients with severe diseases of the lungs, liver, kidneys and other vital organs
4. Patients with limb movement impairment caused by diseases such as fractures and arthritis
5. Modified Ashworth Scale (MAS) score \> 3
6. Patients unable to understand and cooperate with limb rehabilitation training due to factors such as severe aphasia
7. Presence of severe visual field defects or visual impairments (e.g., hemianopsia, hemispatial neglect, etc.
8. History of previous stroke
9. A history of severe motor injury and/or surgical intervention of the affected upper limb, such as muscle tear, tendon rupture, rhabdomyolysis
10. Life expectancy of less than 1 year due to the underlying disease
11. Undergoing major surgery within the past 30 days or planning to undergo major surgery within the next 90 days
12. Pregnant or lactating women
13. History of drug or alcohol abuse, head trauma or central nervous system infection; current use of cognition-impairing medications such as psychoactive or sedative drugs
14. With definite psychiatric and psychological disorders, such as depression, anxiety disorder, obsessive-compulsive disorder, schizophrenia, autism, chronic sleep disorder, consciousness disorder, etc.
15. Having implanted electronic devices in the body that interfere with magnetic resonance imaging (MRI), such as cochlear implants, cardiac pacemakers/defibrillators, drug delivery pumps
16. Poor compliance of the subject, their family members and caregivers, or inability to complete at least 12 months of follow-up as required by the study
17. Having been enrolled in other clinical studies that conflict with this study
18. Judged by the Indication Evaluation Committee as ineligible for or not falling within the scope of this study.

Outcomes:
Changes in Fugl-Meyer Assessment of the Upper Extremity for the affected upper limb at the forth week after enrollment.