A Neurofeedback Interface in Poststroke Neuromodulation Using TMS-fNIRS

NCT ID: NCT07088107

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2028-12-30

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.

Detailed Description

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

functional near-infrared spectroscopy (fNIRS)-triggered TMS

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

Group Type: EXPERIMENTAL

fNIRS-triggered TMS

Intervention Type: DEVICE

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

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

The TMS will be triggered by fNIRS obtained by another participant.

Group Type: SHAM_COMPARATOR

fNIRS-triggered TMS

Intervention Type: DEVICE

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

Interventions

fNIRS-triggered TMS

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Participants who meet the following criteria will be included:

1. Diagnosed with ischemic subcortical stroke, with stroke onset≥6 months.

2. Age between 18 and 80 years.

3. Residual upper limb functions between levels 2-7 in the FTHUE.

4. Capable of providing informed written consent.

5. Capable of reading and communicating with Chinese.

Exclusion Criteria

Patients who meet any of the following criteria will be excluded:

1. any contraindications to TMS (screened by the safety checklist by Rossi).

2. Diagnosed with any concomitant neurological disease other than stroke.

3. signs of cognitive impairment, with a Montreal cognitive assessment score<21/22 out of 30.

4. Severe spasticity in the hemiparetic upper limb muscles, with a Modified Ashworth score > 2.

5. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Countries

Hong Kong

Central Contacts

Jack Jiaqi Zhang, PhD

Role: CONTACT

jack-jiaqi.zhang@polyu.edu.hk

27666696

Facility Contacts

Jack Jiaqi Zhang

Role: primary

jack-jiaqi.zhang@polyu.edu.hk

6696

Other Identifiers

HSEARS20240902001

Identifier Type: -

Identifier Source: org_study_id