fNIRS-BCI Neurofeedback in Stroke Rehabilitation

Not Applicable

Recruiting

• Conditions: Stroke

• 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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-10
• Study First Posted: 2024-07-16
• Study Start: 2024-12-12
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-13
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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; 🇭🇰 Hong Kong, Hong Kong