A Neurofeedback Interface in Poststroke Neuromodulation Using TMS-fNIRS

The Hong Kong Polytechnic University

Status: Not yet enrolling

Conditions: Stroke

Treatments: Device: fNIRS-triggered TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT07088107

HSEARS20240902001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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100 participants in 2 patient groups

functional near-infrared spectroscopy (fNIRS)-triggered TMS

Experimental group

Description:

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.

Treatment:

Device: fNIRS-triggered TMS

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

Sham Comparator group

Description:

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

Treatment:

Device: fNIRS-triggered TMS