Electroacupuncture at Jing-Well Points for Chronic Disorders of Consciousness: A Randomized Controlled Study With Multimodal Assessment
基于多模态评估的电针刺激井穴疗法治疗慢性意识障碍的随机对照研究
意识障碍(DOC)是严重中枢神经系统损伤的常见并发症。持续超过28天定义为长期DOC。全球约有30万至80万患者受到影响,年死亡率为29%-50%,给社会和家庭带来沉重负担。
尽管在病理生理学方面取得了进展,但临床结果仍不理想,DOC的觉醒治疗仍然具有挑战性。国际推荐的疗法,如神经营养药物、高压氧和侵入性神经调控,存在副作用或疗效不确定。
在中医中,创伤性脑损伤后的DOC被归类为“神昏”。井穴放血通过调节气血、疏通经络来促进觉醒。初步研究表明,它可能改善DOC患者的意识,但样本量小且观察周期短。
针灸,如醒脑开窍法,通过改善脑血流和激活神经网络来诱导觉醒。我们团队提出了“井穴-脑相关”假说,并发现井穴电刺激可改善认知功能,但缺乏标准化评估和大样本证据。
需要进一步研究以确认其疗效、机制和适宜人群,从而提供高质量的循证支持。
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Lvping Li, Master
- 电话号码:13542799020
- 邮箱:4531027@qq.com
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
入选标准:
符合上述pDoC诊断标准,并且基于至少两次使用昏迷恢复量表-修订版(CRS-R)评估诊断为指导性昏迷状态(VS)/无反应觉醒综合征(UWS)或最低意识状态(MCS);
首次出现意识障碍,病因明确(外伤性脑损伤/脑内出血/脑梗死),病史完整;
无明显脑积水或严重脑萎缩,病程28天至6个月之间;
- 年龄在18岁至72岁之间,无性别限制;
- 发病前无明显的认知、听力或视力障碍;
- 发病前能准确使用中文交流,无重大神经或精神疾病史;
- 临床上稳定,近3个月内未参与其他临床试验;
- 由患者家属或法定代理人签署知情同意书。
排除标准:
病因不明的意识障碍患者;
因神经退行性疾病、颅内感染或脑瘤手术后处于昏迷状态的患者;
有严重并发症的患者;
心率超过年龄预测最大心率的70%,比静息心率下降>20%,<40次/分,或>130次/分;
血氧饱和度<88%;收缩压>180 mmHg,或出现体位性低血压,平均动脉压<65 mmHg或>110 mmHg;
体内有金属植入物(如心脏起搏器或脊髓刺激器)的患者;
- 发病前有物质滥用史的患者;
刺激区域存在痛觉过敏,不适合接受井穴电刺激的患者;
- 任何其他可能影响评估和治疗的因素的患者;
癫痫发作未控制或出现癫痫持续状态的患者;
- 因颅骨缺损或其他原因无法在相应部位测量ERP的患者;
妊娠期女性患者。
学习计划
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:电针组
在常规治疗基础上(与对照组相同),患者额外接受井穴电刺激。
采用华佗电针治疗仪(型号:SDZ-V)。 刺激双侧井穴,强度调整至引起轻微肢体运动。 每次治疗60分钟,每日1次,每周6次,连续3周。 电针每隔两天更换一次以防止感染。 |
使用华佗电针仪(型号:SDZ-V)。
刺激双侧井穴,强度以引起轻微肢体运动为准。
每次治疗持续60分钟,每日1次,每周6次,连续3周。
电针每两天更换一次以防感染。
|
|
其他:Waiting-treatment group
All patients received routine treatment, including neurotrophic therapy, hyperbaric oxygen therapy, conventional medication, and other general rehabilitation interventions, as well as management of complications: prevention of gastric mucosal lesions, blood glucose control, and prophylaxis against aspiration pneumonia, deep venous thrombosis of the lower extremities, pressure ulcers, etc.Electrostimulation treatment was administered to patients at the end of the follow-up period.
|
使用华佗电针仪(型号:SDZ-V)。
刺激双侧井穴,强度以引起轻微肢体运动为准。
每次治疗持续60分钟,每日1次,每周6次,连续3周。
电针每两天更换一次以防感染。
|
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 |
|---|---|---|
|
coma recovery scale-revised
大体时间:"Baseline (Day 0, pre-first treatment)";"Day 10 post-enrollment (post 9th treatment)";"Day 20 post-enrollment (post all 18 treatments, end of 3-week treatment)"
|
The CRS-R scale consists of six subscales: auditory function, visual function, motor function, oromotor function, communication, and arousal level.It has a total score range of 0-23 points; a higher score indicates a less severe disorder of consciousness.
|
"Baseline (Day 0, pre-first treatment)";"Day 10 post-enrollment (post 9th treatment)";"Day 20 post-enrollment (post all 18 treatments, end of 3-week treatment)"
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Full Outline of UnResponsiveness
大体时间:"Baseline (Day 0, pre-first treatment)";"Day 10 post-enrollment (post 9th treatment)";"Day 20 post-enrollment (post all 18 treatments, end of 3-week treatment)"
|
The FOUR Score was developed as a supplement and refinement to the Glasgow Coma Scale (GCS), and is particularly suitable for assessing patients with severely impaired consciousness or those receiving sedation or intubation in intensive care settings.
It consists of four assessment dimensions, evaluating neurological functions including eye response, motor response, brainstem reflexes, and respiratory pattern.
Each dimension is scored up to 4 points, with a total score ranging from 0 to 16; lower scores indicate worse neurological status.
|
"Baseline (Day 0, pre-first treatment)";"Day 10 post-enrollment (post 9th treatment)";"Day 20 post-enrollment (post all 18 treatments, end of 3-week treatment)"
|
|
Glasgow Outcome Scale-Extended
大体时间:"Baseline"、"1 month after treatment completion"
|
GOSE scores were categorized into favorable outcome (GOSE score 4-8) and unfavorable outcome (GOSE score 1-3).
Participants (or their informants) were asked to report dysfunction in six major life domains: independence at home, independence outside the home, work functioning, social/leisure functioning, relationship problems, and other problems affecting daily life.
|
"Baseline"、"1 month after treatment completion"
|
|
Disability Rating Scale
大体时间:"Baseline";"1 month after treatment completion"
|
The Disability Rating Scale (DRS) has a broader focus.
It is designed to measure the severity of disability following brain injury and its changes over time, covering the entire continuum from coma to community reintegration.
It consists of four assessment stages, which evaluate arousal, consciousness and responsiveness, cognitive abilities, functional dependence, and psychosocial adaptation in a staged manner.
The total score ranges from 0 (no disability) to 29 (vegetative state) or 30 (death).
|
"Baseline";"1 month after treatment completion"
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mismatch Negativity
大体时间:"Baseline (Day 0, pre-first treatment)";"Day 10 post-enrollment (post 9th treatment)";"Day 20 post-enrollment (post all 18 treatments, end of 3-week treatment)"
|
MMN (mismatch negativity) is an auditory evoked potential that reflects the brain's ability to automatically analyze and process sensory information, namely the pre-attentive processing.
It can be used to assess the integrity of the brain's sensory processing system and help determine the conscious state and prognosis of patients with disorders of consciousness (DOC).
Changes in its amplitude and latency are correlated with the likelihood of consciousness recovery, and patients with higher amplitude and shorter latency have a relatively greater chance of regaining consciousness.
|
"Baseline (Day 0, pre-first treatment)";"Day 10 post-enrollment (post 9th treatment)";"Day 20 post-enrollment (post all 18 treatments, end of 3-week treatment)"
|
|
P300
大体时间:"Baseline (Day 0, pre-first treatment)";"Day 10 post-enrollment (post 9th treatment)";"Day 20 post-enrollment (post all 18 treatments, end of 3-week treatment)"
|
P300, like MMN, is also an event-related potential that does not require active movement from the patient, but reflects a higher-order attention-cognitive processing mechanism.
Whereas MMN is responsible for pre-attentive automatic detection of deviant stimuli, P300 represents the engagement of conscious attentional resources and the updating of working memory.
Therefore, in the assessment of patients with prolonged disorders of consciousness (pDoC), P300 provides information at the consciousness-related level rather than the pre-attentive level, and can be used to determine whether patients retain top-down cognitive processing abilities.
|
"Baseline (Day 0, pre-first treatment)";"Day 10 post-enrollment (post 9th treatment)";"Day 20 post-enrollment (post all 18 treatments, end of 3-week treatment)"
|
|
Neuron-Specific Enolase
大体时间:"Baseline (Day 0, pre-first treatment)";"Day 20 post-enrollment (post all 18 treatments, end of 3-week treatment)"
|
NSE is a marker enzyme of neurons.
Following craniocerebral injury, changes in serum levels of this biomarker can reflect damage and recovery of nerve cells.
Monitoring protein levels of NSE may provide clues to the biological mechanisms underlying consciousness recovery.
|
"Baseline (Day 0, pre-first treatment)";"Day 20 post-enrollment (post all 18 treatments, end of 3-week treatment)"
|
合作者和调查者
调查人员
- 研究主任:Lvping Li, Master、The Third People's Hospital of Huizhou
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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