Multilevel Multimodal Neurophysiological Integration for Investigating the Network Modulatory Mechanisms of Epidural Spinal Cord Stimulation
2026년 7월 23일 업데이트: 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.
연구 개요
상태
모병
정황
상세 설명
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.
연구 유형
관찰
등록 (추정된)
30
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Sheng-Tzung Tsai, M.D., Ph.D.
- 전화번호: 13054 +886-3-856-1825
- 이메일: flydream.tsai@gmail.com
연구 연락처 백업
- 이름: Yu-Chen Chen, M.D., Ph.D
- 전화번호: 13054 +886-3-856-1825
- 이메일: spring810569@gmail.com
연구 장소
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Hualien City, 대만
- 모병
- Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
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연락하다:
- Sheng-Tzung Tsai, M.D., Ph.D
- 전화번호: 13054 +886-3-856-1825
- 이메일: flydream.tsai@gmail.com
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연락하다:
- Yu-Chen Chen, M.D., Ph.D
- 전화번호: 13054 +886-3-856-182
- 이메일: spring810569@gmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
Neurosurgery patient at Buddhist Tzu Chi General Hospital, Hualien
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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.
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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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Peak-to-peak amplitude of spinal evoked responses
기간: baseline; at 7、20 days after the implantation
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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.
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baseline; at 7、20 days after the implantation
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Latency of spinal evoked responses
기간: baseline; at 7、20 days after the implantation
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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.
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baseline; at 7、20 days after the implantation
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Area under the curve (AUC) of spinal evoked responses
기간: Baseline; at 7、20 days after the implantation
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The area under the evoked response waveform will be calculated in µV、RMT(%)) to quantify the overall neural response elicited by stimulation.
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Baseline; at 7、20 days after the implantation
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Recruitment curve of spinal evoked responses
기간: baseline; at 7、20 days after the implantation
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Recruitment curves will be constructed by plotting peak-to-peak amplitude (µV) to characterize spinal neural excitability and recruitment properties.
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baseline; at 7、20 days after the implantation
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EEG spectral power
기간: baseline; 7、20 days after the implantation
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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.
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baseline; 7、20 days after the implantation
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SEG spectral power
기간: baseline; 7、20 days after the implantation
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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.
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baseline; 7、20 days after the implantation
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Yu-Chen Chen, M.D., Ph.D, Hualien Tzu Chi General Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2030년 12월 31일
연구 완료 (추정된)
2030년 12월 31일
연구 등록 날짜
최초 제출
2026년 7월 20일
QC 기준을 충족하는 최초 제출
2026년 7월 23일
처음 게시됨 (실제)
2026년 7월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 23일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .