FNIRS-BCI Neurofeedback in Stroke Rehabilitation
- Conditions
- Stroke
- Interventions
- Device: Sham brain-computer interfaceDevice: Brain-computer interface
- Registration Number
- NCT06503484
- Lead Sponsor
- The Hong Kong Polytechnic University
- Brief 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 44 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.
- Detailed Description
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 44 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 44
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham BCI training Sham brain-computer interface In the sham group, patients will wear identical equipment to the BCI group. However, the visual feedback presented in the digital mirror therapy system will be given based on the brain activity of another participant in the BCI group, i.e., yoked sham neurofeedback. Like the BCI group, patients will be instructed to use kinesthetic motor imagery and imitate the movement when receiving visual feedback. The sham training will also last for around 75-90 minutes per session. BCI training Brain-computer interface Patients will be instructed to perform kinesthetic motor imagery of the affected upper extremity in response to a visual cue given by the BCI system. The patients will be instructed to do motor imagery. The level of oxygenated hemoglobin (HbO) will be extracted from the ipsilesional motor cortex as the signal intensity. The signal intensity will be quantified as the percent signal change relative to the baseline. Once the signal intensity reaches the predefined individual threshold, patients will receive neurofeedback in the form of visual feedback, presented in a digital mirror therapy system. The visual feedback guides the patients to perform observational imitation using the affected upper limb. The training will last for around 75-90 minutes per session.
- Primary Outcome Measures
Name Time Method The Fugl-Meyer Assessment - Upper Extremity Scores (FMA-UE) At one-month 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.
- Secondary Outcome Measures
Name Time Method The Action Research Arm Test (ARAT) At one-month 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.
Trial Locations
- Locations (1)
Jack Jiaqi Zhang
ðŸ‡ðŸ‡°Hong Kong, Hong Kong