Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID07088107

Development and Validation of an Adaptive Neurofeedback Interface Using Transcranial Magnetic Stimulation to Modulate Cortical Excitability in Stroke Patients

Led by The Hong Kong Polytechnic University · Updated on 2026-06-01

20

Participants Needed

2

Research Sites

52 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

Researchers are investigating a new neurofeedback system combining transcranial magnetic stimulation (TMS) with functional near-infrared spectroscopy (fNIRS) to improve neuromodulation therapy for stroke patients. This study aims to address the variability in current open-loop TMS treatments by developing a closed-loop interface that precisely controls TMS timing based on brain hemodynamic signals. The study will first test this system's accuracy in healthy adults and then evaluate its effectiveness in post-acute stroke patients to enhance motor control and brain excitability after stroke. The study includes two groups: one where TMS pulses are triggered based on individualized fNIRS signals during motor imagination, and another where TMS is triggered by an operator following a set protocol. The researchers will compare these methods to assess the neurofeedback interface's ability to modulate brain activity. This interventional trial uses a randomized design and single masking to evaluate the device's impact on stroke recovery. Participants will undergo assessments including motor evoked potentials to measure brain response before and after treatment. The study involves monitoring motor function and cortical excitability, with safety assessments to exclude those with contraindications to TMS or cognitive impairments. The total participation age range is 18 to 80 years, and participants must be able to consent and communicate in Chinese. The trial is sponsored by The Hong Kong Polytechnic University and plans to complete by the end of 2028.

CONDITIONS

Brief Title

A Neurofeedback Interface in Poststroke Neuromodulation Using TMS-fNIRS

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with ischemic subcortical stroke with stroke onset 6 months or more ago
  • Aged between 18 and 80 years
  • Residual upper limb function levels between 2 and 7 in the FTHUE scale
  • Able to provide informed written consent
  • Able to read and communicate in Chinese
Not Eligible

You will not qualify if you...

  • Any contraindications to TMS as screened by safety checklist
  • Signs of cognitive impairment with Montreal cognitive assessment score below 21/22 out of 30
  • Moderate-to-severe chronic illnesses such as uncontrolled hypertension, heart disease, or renal failure
  • Healthy participants must be aged 18 to 80 with no neurological diseases or moderate-to-severe chronic illnesses

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Not specified

Participants undergo neurofeedback sessions where transcranial magnetic stimulation (TMS) is triggered by functional near-infrared spectroscopy (fNIRS) signals to modulate cortical excitability.

Trial Site Locations

Total: 2 locations

1

Hong Kong Polytechnic University

Hong Kong, Hong Kong, 000000

Not Yet Recruiting

2

Hong Kong Polytechnic University - Brain Stimulation Laboratory

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

J

Jack Jiaqi Zhang, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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