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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
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⁃ 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.

Locations
Other Locations
Hong Kong Special Administrative Region
Hong Kong Polytechnic University
NOT_YET_RECRUITING
Hong Kong
Hong Kong Polytechnic University - Brain Stimulation Laboratory
RECRUITING
Hong Kong
Contact Information
Primary
Jack Jiaqi Zhang, PhD
jack-jiaqi.zhang@polyu.edu.hk
27666696
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 100
Treatments
Experimental: 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 high-excitability phase of fNIRS hemodynamic response during motor imagination.
Active_comparator: TMS
The TMS will be triggered by the operator according to a pre-defined protocol
Related Therapeutic Areas
Sponsors
Collaborators: RWTH Aachen University
Leads: The Hong Kong Polytechnic University

This content was sourced from clinicaltrials.gov