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Multilevel Multimodal Neurophysiological Integration for Investigating the Network Modulatory Mechanisms of Epidural Spinal Cord Stimulation

2026年7月23日 更新者：Buddhist Tzu Chi General Hospital
This study will examine how the brain, spinal cord, and muscles communicate in people with spinal cord injury. Researchers will use noninvasive brain and muscle recordings together with spinal electrical recordings to better understand how epidural spinal cord stimulation (EES) affects nerve function. The results may help develop more effective and personalized rehabilitation treatments for people with spinal cord injury.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This study aims to investigate the neural activity of individuals with SCI by simultaneously recording spinal electrograms (SEG), electroencephalography (EEG), and electromyography (EMG). Multimodal neurophysiological recordings will be used to evaluate communication between the brain, spinal cord, and muscles before and after EES. Clinical assessments of neurological function, upper extremity motor performance, and functional independence will also be performed to examine the relationship between electrophysiological changes and functional recovery.

研究类型

观察性的

注册 (估计的)

30

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 台湾
      • Hualien City、台湾
        • 招聘中
        • Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
        • 接触：
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Neurosurgery patient at Buddhist Tzu Chi General Hospital, Hualien

描述

Inclusion Criteria:

A. Non-Spinal Cord Injury (Non-SCI) Group

  • Individuals without spinal cord injury.
  • Patients diagnosed with chronic neuropathic pain who meet the criteria for routine temporary epidural spinal cord stimulation (EES) implantation therapy.
  • Patients who have undergone temporary epidural spinal cord stimulation (EES) implantation.
  • Ability to understand and follow motor instructions.
  • Age between 20 and 70 years. B. Spinal Cord Injury (SCI) Group
  • Patients with chronic spinal cord injury.
  • Patients who have undergone temporary epidural spinal cord stimulation (EES) implantation.
  • American Spinal Injury Association Impairment Scale (AIS) grades A-D.
  • Spinal cord injury levels between C3 and L1.
  • Ability to understand and follow motor instructions.
  • Age between 20 and 70 years.

Exclusion Criteria:

  • Individuals with severe psychiatric disorders or cognitive impairments, including major depressive disorder, schizophrenia, or dementia, that may affect their ability to understand the study procedures or comply with study instructions.
  • Individuals who are unable to maintain consciousness, follow instructions, or complete study tasks, including motor tasks, isometric contractions, or resting-state tasks.
  • Individuals with severe medical conditions and unstable clinical status, such as uncontrolled cardiovascular disease, severe infection, respiratory failure, or other conditions deemed unsuitable for study participation by the attending physician.
  • Individuals with abnormal positioning, inadequate fixation, or complications related to temporary epidural spinal cord stimulation (EES) leads, including infection, significant pain, or neurological deterioration, as determined by clinical evaluation to be unsuitable for study recordings.
  • Individuals currently using medications that may significantly affect neurophysiological signals, such as high-dose sedatives, anesthetic agents, or other medications considered by the research team to interfere with data interpretation.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Group without spinal cord injury
Adults aged 20-70 years without spinal cord injury who have chronic neuropathic pain and have undergone temporary epidural spinal cord stimulation (EES). Neural activity will be evaluated using simultaneous spinal electrogram (SEG), electroencephalography (EEG), and electromyography (EMG) recordings during EES.
Spinal cord injury group
This cohort includes adults aged 20-70 years with chronic spinal cord injury who have undergone temporary epidural spinal cord stimulation (EES). Participants with AIS grades A-D and injury levels from C3 to L1 will be included. Neural activity will be evaluated using spinal electrogram (SEG), electroencephalography (EEG), and electromyography (EMG) recordings during EES.
设备：participants will be divided into two disease cohorts: the spinal cord injury (SCI) group and the non-spinal cord injury (non-SCI) group.
This observational case-control study includes two groups: a spinal cord injury (SCI) group and a non-SCI group. The SCI group consists of patients diagnosed with SCI by physicians. Both groups have undergone temporary epidural spinal cord stimulation (EES), and spinal electrophysiological signals will be recorded during stimulation in the SCI group to evaluate neural activity.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Peak-to-peak amplitude of spinal evoked responses
大体时间：baseline; at 7、20 days after the implantation
Peak-to-peak amplitude of spinal evoked responses will be measured in microvolts (µV) to quantify the magnitude of neural activation under different stimulation conditions.
baseline; at 7、20 days after the implantation
Latency of spinal evoked responses
大体时间：baseline; at 7、20 days after the implantation
Response latency of spinal evoked responses will be measured in milliseconds (ms) from stimulus onset to the onset or peak of the response to evaluate neural conduction characteristics.
baseline; at 7、20 days after the implantation
Area under the curve (AUC) of spinal evoked responses
大体时间：Baseline; at 7、20 days after the implantation
The area under the evoked response waveform will be calculated in µV、RMT(%)) to quantify the overall neural response elicited by stimulation.
Baseline; at 7、20 days after the implantation
Recruitment curve of spinal evoked responses
大体时间：baseline; at 7、20 days after the implantation
Recruitment curves will be constructed by plotting peak-to-peak amplitude (µV) to characterize spinal neural excitability and recruitment properties.
baseline; at 7、20 days after the implantation
EEG spectral power
大体时间：baseline; 7、20 days after the implantation
EEG spectral power will be calculated using Morlet wavelet transform and expressed in decibels (dB) for the theta (θ), alpha (α), beta (β), and gamma (γ) frequency bands to quantify changes in neural oscillatory activity.
baseline; 7、20 days after the implantation
SEG spectral power
大体时间：baseline; 7、20 days after the implantation
SEG spectral power will be calculated using Morlet wavelet transform and expressed in decibels (dB) for the theta (θ), alpha (α), beta (β), and gamma (γ) frequency bands to quantify changes in spinal neural oscillatory activity.
baseline; 7、20 days after the implantation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Buddhist Tzu Chi General Hospital

调查人员

  • 首席研究员：Yu-Chen Chen, M.D., Ph.D、Hualien Tzu Chi General Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2030年12月31日

研究完成 (估计的)

2030年12月31日

研究注册日期

首次提交

2026年7月20日

首先提交符合 QC 标准的

2026年7月23日

首次发布 (实际的)

2026年7月29日

研究记录更新

最后更新发布 (实际的)

2026年7月29日

上次提交的符合 QC 标准的更新

2026年7月23日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • IRB115-040-A

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

是的

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