Utilizing a Brain-Computer Interface for Observational Imitation Training to Enhance Upper Limb Motor Recovery Post-Stroke: A Randomized Controlled Trial
NCT Number: NCT06503484
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: DEVICE: Brain-computer interface|DEVICE: Sham brain-computer interface
Sponsor: The Hong Kong Polytechnic University
Collaborators: Tung Wah Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2025-12-01
Locations: Jack Jiaqi Zhang, Hong Kong, 000000, Hong Kong

Summary:
Objectives: 1) To compare the effects of closed-loop brain-computer interface (BCI) driven observational imitation training versus sham BCI open-loop observational imitation training on improving upper limb motor functions in patients with stroke; 2) To investigate whether stroke patients receiving closed-loop training exhibit higher activation levels in the mirror neurons, measured by event-related desynchronization (ERD), compared to those receiving open-loop training.

Hypothesis to be tested: The closed-loop training is more effective than open-loop training in improving upper limb motor outcomes, and there is an increase in the mirror neurons activity in those receiving closed-loop training.

Design and subjects: A randomized controlled trial with 50 participants with stroke.

Study instruments: Functional near-infrared spectroscopy (fNIRS)-based BCI and electroencephalography (EEG).

Interventions: In the BCI training, participants will engage in kinesthetic motor imagery. When the M1 activation level recorded by fNIRS surpasses a predefined threshold, participants will receive visual feedback to guide them to imitate the movement. However, for participants in the sham BCI group, the visual feedback will be given based on the brain activity of another participant in the real BCI group, i.e., yoked sham neurofeedback. Both types of training consist of ten sessions.

Main outcome measures: Upper limb motor tests and the activity of mirror neurons measured by sensorimotor ERD using EEG.

Data analysis: Analysis of variance and correlation. Expected results: The closed-loop BCI-driven observational imitation training is more effective than sham BCI open-loop training on enhancing hemiplegic upper limb functions and the activation of the mirror neurons in patients after stroke.

Primary Outcome Measures: The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE), The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE) evaluates upper limb motor impairment post-stroke. It assesses the movement, coordination, and reflex actions of the hemiplegic upper limb. The total scores are 66., Baseline|The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE), The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE) evaluates upper limb motor impairment post-stroke. It assesses the movement, coordination, and reflex actions of the hemiplegic upper limb. The total scores are 66., At 2 weeks|The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE), The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE) evaluates upper limb motor impairment post-stroke. It assesses the movement, coordination, and reflex actions of the hemiplegic upper limb. The total scores are 66., At one-month
Secondary Outcome Measures: The Action Research Arm Test (ARAT), The Action Research Arm Test (ARAT) is an assessment for upper limb functional activities post-stroke, with four subscales to evaluate grasp, grip, pinch, and gross movement, with total scores of 57., Baseline|The Action Research Arm Test (ARAT), The Action Research Arm Test (ARAT) is an assessment for upper limb functional activities post-stroke, with four subscales to evaluate grasp, grip, pinch, and gross movement, with total scores of 57., At 2 weeks|The Action Research Arm Test (ARAT), The Action Research Arm Test (ARAT) is an assessment for upper limb functional activities post-stroke, with four subscales to evaluate grasp, grip, pinch, and gross movement, with total scores of 57., At one-month