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.
調査の概要
状態
募集
条件
詳細な説明
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.
研究の種類
観察的
入学 (推定)
30
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Sheng-Tzung Tsai, M.D., Ph.D.
- 電話番号：13054 +886-3-856-1825
- メール：flydream.tsai@gmail.com
研究連絡先のバックアップ
- 名前：Yu-Chen Chen, M.D., Ph.D
- 電話番号：13054 +886-3-856-1825
- メール：spring810569@gmail.com
研究場所
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Hualien City、台湾
- 募集
- Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
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コンタクト：
- Sheng-Tzung Tsai, M.D., Ph.D
- 電話番号：13054 +886-3-856-1825
- メール：flydream.tsai@gmail.com
-
コンタクト：
- Yu-Chen Chen, M.D., Ph.D
- 電話番号：13054 +886-3-856-182
- メール：spring810569@gmail.com
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
Neurosurgery patient at Buddhist Tzu Chi General Hospital, Hualien
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Peak-to-peak amplitude of spinal evoked responses
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Yu-Chen Chen, M.D., Ph.D、Hualien Tzu Chi General Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2030年12月31日
研究の完了 (推定)
2030年12月31日
試験登録日
最初に提出
2026年7月20日
QC基準を満たした最初の提出物
2026年7月23日
最初の投稿 (実際)
2026年7月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月29日
QC基準を満たした最後の更新が送信されました
2026年7月23日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。