A Neurofeedback Interface in Poststroke Neuromodulation Using TMS-fNIRS

NCT07088107 | Recruiting DMC

• 1 other identifier: HSEARS20240902001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Stroke is a type of cerebrovascular disease, and the primary characteristic of post-stroke brains is pathological changes in cerebral hemodynamics. Therefore, hemodynamic signals may provide straightforward information for guiding post-stroke neuromodulation therapy. Transcranial magnetic stimulation (TMS), a non-invasive neurostimulation modality, has been extensively used in post-stroke rehabilitation. However, current TMS-based neuromodulation therapy demonstrates a large treatment response variability due to its open-loop nature. To address this challenge, the research team will develop a novel form of closed-loop neurofeedback interfaces which controls the timing of TMS pulses precisely based on neural biomarkers from functional near-infrared spectroscopy (fNIRS) and test the accuracy of the adaptive neurofeedback system in healthy adults. After establishing the TMS-based neurofeedback interface, a proof-of-concept study enrolling postacute stroke patients will be performed to evaluate the efficacy of the TMS neurofeedback interface in enhancing motor control of the hemiplegic upper extremity and cortical excitability of the ipsilesional motor cortex. These findings will verify whether the proposed fNIRS-controlled TMS neurofeedback interface can be clinically feasible as a form of post-stroke neuromodulation therapy. Additionally, the results will significantly contribute to the scientific understanding of how neuromodulation improves hemodynamic signals in a closed-loop manner, thereby enhancing functional recovery in poststroke survivors.

Conditions

Stroke

Keywords

Stroke; Neurofeedback; Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• Motor evoked potential

  Motor Evoked Potentials (MEPs) are electrical signals generated by stimulating the motor cortex and recorded from the peripheral muscle (e.g., a hand muscle). This is a measure of corticospinal excitability.

  Baseline

Study Arms (2)

functional near-infrared spectroscopy (fNIRS)-triggered TMS

EXPERIMENTAL

The TMS will be triggered based on individualized fNIRS signals from the participants. Specifically, the TMS will be triggered during high-excitability phase of fNIRS hemodynamic response during motor imagination.

Device: fNIRS-triggered TMS

TMS

ACTIVE COMPARATOR

The TMS will be triggered by the operator according to a pre-defined protocol

Device: fNIRS-triggered TMS

Interventions

fNIRS-triggered TMS DEVICE

The firing of TMS will be triggered according to fNIRS signal intensity.

TMS; functional near-infrared spectroscopy (fNIRS)-triggered TMS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who meet the following criteria will be included:
• Diagnosed with ischemic subcortical stroke, with stroke onset≥6 months.
• Age between 18 and 80 years.
• Residual upper limb functions between levels 2-7 in the FTHUE.
• Capable of providing informed written consent.
• Capable of reading and communicating with Chinese.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded:
• any contraindications to TMS (screened by the safety checklist by Rossi).
• signs of cognitive impairment, with a Montreal cognitive assessment score\<21/22 out of 30.
• any moderate-to-severe chronic illness, such as uncontrolled hypertension, heart disease or renal failure.
• Healthy participants should be aged between 18 and 80, with no known history of neurological diseases. They should not have any moderate-to-severe chronic illness, such as uncontrolled hypertension, heart disease or renal failure.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• RWTH Aachen University: collaborator

Study Sites (2)

Hong Kong Polytechnic University

Hong Kong, 000000, Hong Kong

NOT YET RECRUITING

Hong Kong Polytechnic University - Brain Stimulation Laboratory

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jack Jiaqi Zhang, PhD

CONTACT

27666696; jack-jiaqi.zhang@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: July 28, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 3, 2026

Record last verified: 2025-07

Locations

HK (2)