跳至主要内容
临床试验/NCT07088107
NCT07088107进行中(未招募)不适用

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

The Hong Kong Polytechnic University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
2
主要终点
Motor evoked potential

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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
  • •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.

研究组 & 干预措施

TMS

Active Comparator

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

干预措施: fNIRS-triggered TMS (Device)

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.

干预措施: fNIRS-triggered TMS (Device)

结局指标

主要结局

Motor evoked potential

时间窗: Baseline

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验