Prospective, Randomized, Parallel-Controlled Study of Brain Computer Interface Integrated Robotic Mirror Therapy for Post-Stroke Upper Limb Motor Function Disorder

N/ANot Yet RecruitingNCT07553416

Beijing Tiantan Hospital40 enrolled

Overview

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.

This is a prospective, single-center, open-label, outcome-assessor-blinded, randomized, parallel-controlled clinical study initiated by investigators. Based on the post-stroke compensatory model theory, this study innovatively combines brain-computer interface and mirror robot technology to build a dynamic closed-loop feedback system. Using the contralesional compensatory activation mechanism and a designed robot training paradigm, it explores the efficacy of the intervention in improving upper limb motor function and its underlying neural recovery mechanisms.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ischemic Stroke Intracranial Haemorrhage

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Primary Outcomes

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

The primary outcome measure of this study was the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE), which was employed to assess upper limb motor function in patients. The FMA-UE consists of 33 items, each graded on a 0-2 scale (0 = unable to perform, 1 = partially accomplished, 2 = fully accomplished), with a total score ranging from 0 to 66; higher scores indicate superior upper limb motor function. This scale enables comprehensive evaluation of joint range of motion, reflex activity, isolated motor control, and coordination in the hemiplegic upper extremity of stroke patients.

Time frame: 4 weeks

Secondary Outcomes

The improvement in the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) for the affected upper limb at the eighth week after enrollment.

The FMA-UE consists of 33 items, each graded on a 0-2 scale (0 = unable to perform, 1 = partially accomplished, 2 = fully accomplished), with a total score ranging from 0 to 66; higher scores indicate superior upper limb motor function. This scale enables comprehensive evaluation of joint range of motion, reflex activity, isolated motor control, and coordination in the hemiplegic upper extremity of stroke patients.

Time frame: 8 weeks

Changes in neural conduction pathways at the forth week after enrollment.

Diffusion Tensor Imaging (DTI) enables visualization of cerebral white matter fiber tracts and assessment of the repair of neural conduction pathways. In this study, the unaffected primary motor cortex (M1) was used as the seed region, and the ipsilesional cervical spinal cord was set as the target region. Fractional Anisotropy (FA) values of the fiber tract were extracted. A higher FA value indicates greater integrity of the fiber tract and stronger neural conduction ability.

Time frame: 4 weeks

Differences in changes of electroencephalographic (EEG) signals at the forth week after enrollment.

Electroencephalographic signal acquisition enables the analysis of time-frequency characteristics, spatial features, and functional connectivity in patients before and after rehabilitation intervention. Time-frequency analysis serves as a primary approach to evaluating the efficacy of BCI-RMT training. Spatial feature analysis enables the detailed visualization of the spatial distribution of ERD/ERS in the form of brain topographic maps, which is particularly well-suited for monitoring the spatial pattern of compensatory activation in the unaffected hemisphere and its longitudinal changes throughout the training process. Functional connectivity analysis is primarily employed to investigate information connectivity and exchange patterns among motor-related brain regions.

Time frame: 4 weeks

Improvements in the Wolf Motor Function Test of the affected upper extremity at the forth week and the eighth week after enrollment.

The Wolf Motor Function Test (WMFT) also enables quantitative evaluation of motor function in the hemiplegic upper extremity among stroke patients, with a specific emphasis on the quality of movement execution. As a complementary measure to the FMA-UE, it simulates daily functional activities more comprehensively, covering tasks from single-joint isolated movements (e.g., lateral elbow extension) to multi-joint complex actions (e.g., towel folding). The WMFT comprises 15 items scored according to movement fluency, coordination and accuracy, with each item rated on a 0-5 scale and a total score ranging from 0 to 75; higher scores reflect better upper extremity motor function.

Time frame: 4 weeks and 8 weeks

Improvements in Modified Barthel Index (MBI) scores at the forth week and the eighth week after enrollment.

The Modified Barthel Index (MBI) is utilized to evaluate patients' activities of daily living (ADL). This scale covers basic daily living activities, including feeding, bathing, dressing, toileting, bowel and bladder control, bed-chair transfer, walking on level ground, stair climbing, and grooming (tooth brushing and hair combing). The total score ranges from 0 to 100 points. A higher score indicates greater functional independence: a score of 0 represents complete dependence, whereas a score of 100 indicates full independence.

Time frame: 4 weeks and 8 weeks

Changes in Modified Ashworth Scale (MAS) scores at the forth week and the eighth week after enrollment.

The Modified Ashworth Scale (MAS) is a commonly used clinical scale for assessing limb muscle tone in stroke patients. It evaluates the severity of limb spasticity by sensing changes in resistance during passive joint movement.The MAS comprises six grades: Grade 0, Grade 1, Grade 1+, Grade 2, Grade 3, and Grade 4. A higher grade indicates increased muscle tone.

Time frame: 4 weeks and 8 weeks

Changes in Montreal Cognitive Assessment (MoCA) scores at the forth week and the eighth week after enrollment.

The Montreal Cognitive Assessment (MoCA) can evaluate patients' cognitive function, covering 8 cognitive domains including orientation, executive function, naming, attention, language, abstract thinking, delayed recall and visuospatial ability. It has a total score of 30 points, and a score of ≥26 points indicates normal cognitive function.

Time frame: 4 weeks and 8 weeks

Prospective, Randomized, Parallel-Controlled Study of Brain Computer Interface Integrated Robotic Mirror Therapy for Post-Stroke Upper Limb Motor Function Disorder

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts