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A Neurofeedback Interface in Poststroke Neuromodulation Using TMS-fNIRS

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 8 words
    • Site details revised at 2 of 2 sites
  2. Notable Enrollment reduced: 100 → 20 participantsv3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoints: 2 to 1
    • Study sites: 1 to 2
    • Eligibility criteria shortened, about 24 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07088107
Lead Sponsor The Hong Kong Polytechnic University
Collaborators: RWTH Aachen University
Conditions
(from sponsor)
Stroke
Related terms Stroke
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov