Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06503484

fNIRS-BCI Neurofeedback in Stroke Rehabilitation

Led by The Hong Kong Polytechnic University · Updated on 2025-08-22

44

Participants Needed

1

Research Sites

54 weeks

Total Duration

On this page

Sponsors

T

The Hong Kong Polytechnic University

Lead Sponsor

R

RWTH Aachen University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 will be given constantly. 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.

CONDITIONS

Official Title

fNIRS-BCI Neurofeedback in Stroke Rehabilitation

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have unilateral upper limb motor problems caused by ischemic stroke confirmed by medical records or imaging
  • Be in the chronic phase of stroke with more than six months since stroke onset
  • Be between 18 and 75 years old
  • Have mild to moderate impairment in upper limb function, levels 3-7 on the Functional Test for the Hemiplegic Upper Extremity
  • Be able to give written informed consent to join the study
  • Be able to read and understand traditional Chinese
Not Eligible

You will not qualify if you...

  • Have a previous diagnosis of neurological diseases other than ischemic stroke
  • Show signs of cognitive problems with a Montreal Cognitive Assessment Hong Kong score below 22 out of 30
  • Have severe muscle spasticity with a Modified Ashworth Scale score above 2 in hand, wrist, or elbow muscles on the affected side
  • Have other significant upper limb impairments not caused by stroke, such as recent bone fractures or congenital deformities
  • Be currently participating in another treatment program or clinical study involving exercise, non-invasive brain stimulation, or BCI/neurofeedback

AI-Screening

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Trial Site Locations

Total: 1 location

1

Jack Jiaqi Zhang

Hong Kong, Hong Kong, Hong Kong, 000000

Actively Recruiting

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Research Team

J

Jack Jiaqi Zhang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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