意识障碍患者的时间干扰
2026年7月20日 更新者：Li Zhang, MD、Zhejiang Provincial People's Hospital
暂时干扰意识障碍患者的功效和安全性
该项目将通过给予Ti（时间干扰）治疗来帮助患者恢复意识
研究概览
研究类型
介入性
注册 (实际的)
28
阶段
- 不适用
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。
学习地点
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Zhejiang
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Hangzhou、Zhejiang、中国、310000
- Hangzhou Mingzhou Brain Rehabilitation Hospital
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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
描述
纳入标准：
根据Giacino在2002年提出的MC的国际诊断标准，或Laureys在2010年提出的UWS的诊断标准；疾病持续时间≥28天，过去一个月的无意识改善趋势；在过去的1个月中，不使用任何镇静药或抗癫痫药（钠或钙通道阻滞剂）；稳定的生命体征；没有明显的大脑水肿，脑积水和严重的脑萎缩；年龄从18岁到70岁；从患者的家庭成员那里获得了知情同意。
排除标准：
神经或精神疾病的先前史；以前的脑损伤病史；癌症史；在过去的1个月中服用镇静剂或抗癫痫药；不稳定的生命体征；头骨缺陷；患者的家庭成员没有签署知情同意。
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
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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假比较器：Sham comparator
Participants receive sham TI stimulation one session per day for 5 consecutive days
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The sham TI device is the same as the active comparator's except that no current was delivered during the stimulation period.
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有源比较器：real TI stimulation
Participants receive real TI stimulation one session per day for 5 consecutive days
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Stimulation was delivered as two sinusoidal alternating currents with carrier frequencies of 2000 Hz and 2010 Hz, generating a 10 Hz amplitude-modulated envelope.
Current intensity was set at 3 mA per channel.
Each session included 30-second ramp-up and ramp-down periods at the beginning and end of stimulation.
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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 |
|---|---|---|
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CRS-R (Coma Recovery Scale-revised)
大体时间：Baseline; Within 1 week post-stimulation
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The CRS-R scale, with scores ranging from 0 to 23, a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness.
The scale is intended to be used to establish diagnosis, monitor behavioral recovery, predict outcome, and assess treatment effectiveness.
The CRS-R consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level.
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Baseline; Within 1 week post-stimulation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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EEG spectral power
大体时间：Baseline; Within 1 week post-stimulation
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EEG spectral power was quantified across five canonical frequency bands: delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-40 Hz).
Relative power spectral density (PSD) was calculated for each frequency band.
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Baseline; Within 1 week post-stimulation
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fNIRS-derived hemoglobin concentration changes
大体时间：fNIRS data were acquired over a 40-min session on each of the 5 treatment days.
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Changes in oxygenated hemoglobin (ΔHbO), deoxygenated hemoglobin (ΔHbR), and total hemoglobin (ΔHbT) concentrations were measured using functional near-infrared spectroscopy (fNIRS).
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fNIRS data were acquired over a 40-min session on each of the 5 treatment days.
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GOS-E（Glasgow Outcome Scale - Extended）
大体时间：6 months
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The outcome of patients was divided into 8 grades by GOS-E, and the higher the grade, the better the prognosis.
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6 months
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Changes in CRS-R subscale scores
大体时间：Baseline; Within 1 week post-stimulation and at 1-month, 3-month, and 6-month follow-up.
|
The CRS-R scale, with scores ranging from 0 to 23, a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness.
The scale is intended to be used to establish diagnosis, monitor behavioral recovery, predict outcome, and assess treatment effectiveness.
The CRS-R consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level.
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Baseline; Within 1 week post-stimulation and at 1-month, 3-month, and 6-month follow-up.
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Total CRS-R score changes at follow-up
大体时间：Pre-stimulation, post-stimulation and at 1-month, 3-month, and 6-month follow-up.
|
The CRS-R scale, with scores ranging from 0 to 23, a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness.
The scale is intended to be used to establish diagnosis, monitor behavioral recovery, predict outcome, and assess treatment effectiveness.
The CRS-R consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level.
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Pre-stimulation, post-stimulation and at 1-month, 3-month, and 6-month follow-up.
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EEG functional connectivity
大体时间：Baseline; Within 1 week post-stimulation
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EEG functional connectivity was quantified using phase-locking value (PLV) across five frequency bands: delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-40 Hz).
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Baseline; Within 1 week post-stimulation
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Auditory steady-state response (ASSR)
大体时间：Baseline; Within 1 week post-stimulation
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ASSR was recorded during EEG while participants listened to modulated tones.
ASSR strength was quantified using an amplitude-based signal-to-noise ratio (SNR), calculated as the amplitude at the target frequency divided by the mean amplitude of the surrounding spectral background.
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Baseline; Within 1 week post-stimulation
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fNIRS-derived functional connectivity
大体时间：fNIRS data were acquired over a 40-min session on each of the 5 treatment days.
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Functional connectivity was estimated by calculating Pearson correlation coefficients between fNIRS time series.
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fNIRS data were acquired over a 40-min session on each of the 5 treatment days.
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Zhu Z, Yin L. A mini-review: recent advancements in temporal interference stimulation in modulating brain function and behavior. Front Hum Neurosci. 2023 Sep 14;17:1266753. doi: 10.3389/fnhum.2023.1266753. eCollection 2023.
- Yang C, Xu Y, Feng X, Wang B, Du Y, Wang K, Lu J, Huang L, Qian Z, Wang Z, Chen N, Zhou J, Zhang C, Liu Y. Transcranial Temporal Interference Stimulation of the Right Globus Pallidus in Parkinson's Disease. Mov Disord. 2025 Jun;40(6):1061-1069. doi: 10.1002/mds.29967. Epub 2024 Aug 12.
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 (实际的)
2025年1月20日
初级完成 (实际的)
2025年10月31日
研究完成 (实际的)
2026年4月30日
研究注册日期
首次提交
2025年1月16日
首先提交符合 QC 标准的
2025年2月6日
首次发布 (实际的)
2025年2月12日
研究记录更新
最后更新发布 (实际的)
2026年7月22日
上次提交的符合 QC 标准的更新
2026年7月20日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.