ChiCTR2600122376 版本V1.0 版本创建时间2026/04/13 14:56:09 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2600122376 

最近更新日期：

Date of Last Refreshed on：

2026-04-13 14:56:04 

注册时间：

Date of Registration：

2026-04-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于激光散斑衬比成像技术的岭南接经眼针对颅脑损伤后最小意识状态患者促醒作用的临床研究

Public title：

Clinical Study on the Awakening Effect of Lingnan Jing-Connecting Eye Acupuncture in Patients with Minimally Conscious State after Craniocerebral Injury Based on Laser Speckle Contrast Imaging Technology

注册题目简写：

多模态AI岭南接经眼针促醒评估研究

English Acronym：

MMAI-LJEA-pDoC

研究课题的正式科学名称：

基于激光散斑衬比成像技术的岭南接经眼针对颅脑损伤后最小意识状态患者促醒作用的临床研究

Scientific title：

Clinical Study on the Awakening Effect of Lingnan Jing-Connecting Eye Acupuncture in Patients with Minimally Conscious State after Craniocerebral Injury Based on Laser Speckle Contrast Imaging Technology

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

高雨竹 

研究负责人：

池响峰 

Applicant：

Gao Yuzhu 

Study leader：

Chi Xiangfeng 

申请注册联系人电话：

Applicant telephone：

+86 185 0241 9808

研究负责人电话：

Study leader's telephone：

+86 186 0202 4011

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

parisgao@126.com

研究负责人电子邮件：

Study leader's E-mail：

1109884975@qq.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

中国广东省广州市番禺区大学城外环东路232号

研究负责人通讯地址：

中国广东省广州市黄埔区萝岗公路街212号

Applicant address：

232 East Waihuan Road, Higher Education Mega Center, Panyu District, Guangzhou, Guangdong, China

Study leader's address：

212 Luogang Gonglu Street, Huangpu District, Guangzhou, Guangdong, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

广州中医药大学

Applicant's institution：

Guangzhou University of Chinese Medicine

研究负责人所在单位：

广东省第二中医院(广州中医药大学第五临床医学院)

Affiliation of the Leader：

Guangdong Provincial Second Hospital of Traditional Chinese Medicine (The Fifth Clinical Medical College of Guangzhou University of Chinese Medicine)

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

K202504-003-01

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

广东省第二中医院伦理委员会

Name of the ethic committee：

Ethics Committee of Guangdong Provincial Second Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025-04-25 00:00:00

伦理委员会联系人：

张艺

Contact Name of the ethic committee：

Zhang Yi

伦理委员会联系地址：

中国广东省广州市越秀区恒福路60号

Contact Address of the ethic committee：

60 Hengfu Road, Yuexiu District, Guangzhou, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20 8357 9129

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

广东省第二中医院（广州中医药大学第五临床医学院）

Primary sponsor：

Guangdong Provincial Second Hospital of Traditional Chinese Medicine (The Fifth Clinical Medical College of Guangzhou University of Chinese Medicine)

研究实施负责（组长）单位地址：

中国广东省广州市黄埔区萝岗公路街212号

Primary sponsor's address：

212 Luogang Gonglu Street, Huangpu District, Guangzhou, Guangdong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

广东省第二中医院

具体地址：

中国广东省广州市黄埔区萝岗公路街212号

Institution
hospital：

Guangdong Provincial Second Hospital of Traditional Chinese Medicine

Address：

212 Luogang Gonglu Street, Huangpu District, Guangzhou, Guangdong, China

经费或物资来源：

广州中医药大学与附属医院共建项目科研专项

Source(s) of funding：

Special Research Program for Joint Projects between Guangzhou University of Chinese Medicine and Its Affiliated Hospitals

Target disease：

Prolonged disorders of consciousness

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究旨在观察岭南接经眼针治疗慢性意识障碍患者 2 周住院期的促醒作用，评价其相对于单纯标准化体针的增量疗效，并探索基于脑电图与标准化视频行为的床旁客观评估路径；进一步整合多模态指标和基础临床变量，构建探索性人工智能模型，用于识别第 14 天临床应答并辅助疗效评估。  

Objectives of Study：

This study aims to evaluate the arousal-promoting effect of Lingnan Meridian-Connecting Ocular Acupuncture during a 2-week inpatient treatment period in patients with prolonged disorders of consciousness, to assess its incremental efficacy compared with standardized body acupuncture alone, and to explore a bedside objective assessment pathway based on electroencephalography and standardized video-behavioral evaluation. In addition, multimodal indicators and baseline clinical variables will be integrated to build an exploratory artificial intelligence model for identifying Day-14 clinical response and assisting efficacy evaluation.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 首次发生颅脑损伤，18-80 岁患者。 2. 中医诊断为头部内伤病（痰瘀阻络证）的患者：(1) 有头部外伤或间接外伤史。(2) 伤后出现神志昏迷，烦躁不宁，头晕头痛，恶心呕吐等症。(3) 结合病史和体征、CT、磁共振检查可确定损伤部位及程度。参考中华人民共和国中医药行业标准《中医病证诊断疗效标准》（ZY／T001.1-94）。 3. 发病时间 1 年以内，符合最小意识状态的诊断标准：遵从简单的指令；不管正确如何，可以用姿势或语言来回答是或否；可被理解的语言；有目的性的行为：包括偶然出现的与环境刺激有关的动作和情绪反应，而不是不自主运动；有明确的外伤病史，分为原发性颅脑损伤和继发性颅脑损伤，原发性颅脑损伤是指创伤暴力当时造成的颅脑损伤，如:头皮伤、颅骨骨折、脑震荡、脑挫裂伤等；继发性颅脑损伤是指致伤后一段时间逐步形成的脑损伤，如颅内血肿、脑水肿等。西医标准参考《神经外科学》（赵继宗主编，人民卫生出版社，2007 年）。 4. 体内无金属植入物或起搏器等； 5. 治疗部位无感染、无出血点、无破损； 6. 既往无癫痫病史、无药物滥用及酗酒史； 7. 无右侧正中神经、臂丛神经、颈髓损伤； 8. 无视、听器官器质性损伤； 9. 患者和（或）患者家属同意加入本次临床试验研究，同时依从性高能积极配合治疗者；患者家属签署知情同意书。

Inclusion criteria

1. First-time traumatic brain injury (TBI) in patients aged 18–80 years. 2. Patients diagnosed with internal head injury (Phlegm-Stasis Blocking Collaterals syndrome) according to Traditional Chinese Medicine (TCM) criteria: (1) History of direct or indirect head trauma; (2) Post-injury symptoms such as coma, restlessness, dizziness, headache, nausea, and vomiting; (3) Injury location and severity confirmed by history, physical examination, CT, and MRI, referencing the TCM Industry Standard of the People's Republic of China "Diagnostic and Therapeutic Criteria for TCM Diseases and Syndromes" (ZY/T001.1-94). 3. Disease onset within 1 year, meeting diagnostic criteria for Minimally Conscious State (MCS): following simple commands; answering yes/no via gestures or speech regardless of accuracy; intelligible verbalization; purposeful behavior (including contingent movements and emotional responses to environmental stimuli, distinct from involuntary movements); clear history of trauma, categorized as primary TBI (immediate damage such as scalp injuries, skull fractures, concussion, cerebral contusion/laceration) and secondary TBI (progressive damage such as intracranial hematoma and cerebral edema). Western medical criteria reference "Neurosurgery" (Edited by Zhao Jizong, People's Medical Publishing House, 2007). 4. No metallic implants or pacemakers in the body. 5. No infection, bleeding points, or skin breakdown at the treatment site. 6. No history of epilepsy, drug abuse, or alcoholism. 7. No injury to the right median nerve, brachial plexus, or cervical spinal cord. 8. No organic impairment of vision or hearing organs. 9. Patient and/or legal guardians agree to participate in the clinical trial, demonstrate high compliance and active cooperation, and have signed the informed consent form.

排除标准：

1. 有颅内压增高等颅内病变不稳定者； 2. 脑卒中、颅内感染性疾病、中毒性脑病、其他疾病引起的脑实质损害； 3. 心、肺等器官有严重疾病的患者； 4. 意识障碍发病前有明确的神经发育及精神方面疾病； 5. 镇静催眠药物使用史、药物滥用及酗酒史者； 6. 影响意识改变的因素 (血糖过高过低、电解质紊乱、感染等); 7. 电刺激部位有严重损伤者； 8. 意识障碍逐渐加重或昏迷加深。 9. 凝血功能障碍者。

Exclusion criteria：

1. Pre-existing severe dementia, developmental disability, progressive neurodegenerative disease, or other underlying diseases that may substantially interfere with consciousness assessment. 2. Open cranial trauma, major skull defect, severely poor scalp condition, or other conditions preventing EEG acquisition. 3. Severe eyelid trauma, periocular infection, obvious facial injury, persistent facial obstruction, or other conditions preventing video-behavioral acquisition and rating. 4. Status epilepticus or frequent clinically overt seizures within the previous 72 hours. 5. Requirement for continuous deep sedation, unstable vital signs, or severe heart, lung, liver, or kidney failure. 6. Planned addition of other specialized arousal-promoting treatments during the study period, including but not limited to transcranial magnetic stimulation, transcranial direct current stimulation, vagus nerve stimulation, or hyperbaric oxygen therapy. 7. Any other condition judged by the investigators to make the participant unsuitable for this study.

研究实施时间：

Study execute time：

从 From 2026-04-13 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-04-13 00:00:00 至 To 2026-12-31 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

53

Group：

Trial Group

Sample size：

干预措施：

岭南接经疗法眼针针法：取眼周八区十三穴。具体操作：取三根针灸针，并排捏针，自肺开始参照十二经脉流注次序在眼睑处取穴，行点刺、散刺、放血疗法相结合的针刺手法，要求进针速度快、位置浅表，以潮红出血为度，先针左侧，再针右侧，行针眼周3圈为一组，双目交替进行，共针刺9组。基础治疗包括：营养神经、改善后循环药物；正中神经电刺激；从阴引阳大接经促醒技术（取百会、内关、水沟等穴，针刺后脉冲刺激留针30min）；康复训练（电动起立床、被动活动）。

干预措施代码：

Intervention：

Lingnan Jiejing therapy eye acupuncture: selecting 13 points in 8 zones around the eyes. Specific procedure: using three acupuncture needles held together, starting from the lung meridian and following the sequence of the twelve meridians, puncturing points on the eyelids with combined techniques of point stimulation, scattered stimulation, and blood-letting. Needles should be inserted quickly and superficially, with bleeding until redness appears. Left eye first, then right eye, performing 3 circles around the eye area per group, alternating between both eyes, totaling 9 groups. Basic treatment includes neurotrophic agents, drugs improving posterior circulation; median nerve electrical stimulation; 'From Yin to Yang' large meridian connecting awakening technique (acupuncture at Baihui, Neiguan, Shuigou, etc., followed by pulse stimulation and retention for 30 minutes); rehabilitation training (electric standing bed, passive movements).

Intervention code：

组别：

对照组

样本量：

53

Group：

Control Group

Sample size：

干预措施：

常规针刺促醒针法。主穴：双侧风池、完骨、天柱、哑门、风府；配穴：水沟、四神聪、智三针、颞三针、内关、百会、极泉、委中、曲池、三阴交、足三里等。具体操作：内关捻转泻法运针1分钟；水沟捻转滞针雀啄泻法至眼球湿润；风池透刺；完骨、天柱、哑门、风府捻转泻法直刺1寸。电针连接疏密波刺激；其他穴位常规手法留针30秒捻转行针约200次/分钟。留针30min，每日1次。基础治疗与试验组一致。

干预措施代码：

Intervention：

Conventional acupuncture for awakening. Main points: bilateral Fengchi, Wangu, Tianzhu, Yamen, Fugue; auxiliary points: Shuigou, Sishencong, Zhisanpin, Tiansanpin, Neiguan, Baihui, Jiquan, Weizhong, Quchi, Sanyinjiao, Zusanli. Specific procedures: Neiguan with twisting-reducing method for 1 minute; Shuigou with twisting-stagnation and flicking-reducing method until lacrimation occurs; Fengchi with transcutaneous needling; Wangu, Tianzhu, Yamen, Fugue with twisting-reducing method, straight insertion to 1 cun depth. Electroacupuncture with sparse-dense wave stimulation; other points with conventional techniques, retaining needles for 30 seconds with twisting motion at about 200 times per minute. Retain needles for 30 minutes, once daily. Basic treatment consistent with trial group.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

 广州 

Country：

China 

Province：

Guangdong 

City：

Guangzhou 

单位(医院)：

广东省第二中医院 

单位级别：

三级甲等 

Institution
hospital：

Guangdong Provincial Second Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary Grade A

测量指标：

Outcomes：

指标中文名：

第 14 天 CRS-R 总分较基线变化值

指标类型：

主要指标

Outcome：

Change in total Coma Recovery Scale-Revised (CRS-R) score from baseline to Day 14

Type：

Primary indicator

测量时间点：

第 14 天

测量方法：

由经培训的评价者采用 CRS-R 量表进行评估，比较第 14 天与基线总分差值。

Measure time point of outcome：

Day 14

Measure method：

Assessed by trained evaluators using the CRS-R; the difference between Day 14 and baseline total scores will be analyzed.

指标中文名：

第 14 天临床应答率

指标类型：

次要指标

Outcome：

Clinical response rate at Day 14

Type：

Secondary indicator

测量时间点：

第 14 天

测量方法：

以意识状态分层改善为主，同时记录 CRS-R 增加 >=2 分的受试者比例。

Measure time point of outcome：

Day 14

Measure method：

Primarily defined by improvement in consciousness-state classification, with the proportion of participants showing an increase of at least 2 CRS-R points also recorded.

指标中文名：

第 14 天意识状态分层改善率

指标类型：

次要指标

Outcome：

Improvement rate in consciousness-state classification at Day 14

Type：

Secondary indicator

测量时间点：

第 14 天

测量方法：

根据重复 CRS-R 评估，将基线与第 14 天的 UWS/VS、MCS 或更高分层进行比较。

Measure time point of outcome：

Day 14

Measure method：

Repeated CRS-R assessments will be used to compare baseline and Day-14 classifications of UWS/VS, MCS, or higher recovery states.

指标中文名：

第 14 天 EEG 特征变化

指标类型：

次要指标

Outcome：

Changes in EEG features at Day 14

Type：

Secondary indicator

测量时间点：

基线和第 14 天

测量方法：

采用静息态 EEG 和听觉 oddball EEG，提取 α/δ 比值、谱熵或排列熵、Lempel-Ziv 复杂度、N1 和 MMN 的幅度与潜伏期等指标。

Measure time point of outcome：

Baseline and Day 14

Measure method：

Resting-state EEG and auditory oddball EEG will be used to extract indicators such as alpha/delta ratio, spectral or permutation entropy, Lempel-Ziv complexity, and the amplitude and latency of N1 and MMN.

指标中文名：

第 14 天视频行为指标变化

指标类型：

次要指标

Outcome：

Changes in standardized video-behavioral indicators at Day 14

Type：

Secondary indicator

测量时间点：

基线和第 14 天

测量方法：

通过标准化视频行为评估，记录视觉注视阳性试次比例、视觉追视成功率、睁眼/口周命令反应比例、反应潜伏期及位移幅度等。

Measure time point of outcome：

Baseline and Day 14

Measure method：

Standardized video-behavioral assessment will record the proportion of positive visual fixation trials, visual tracking success rate, response rates to eye-opening/perioral commands, response latency, and movement amplitude.

指标中文名：

安全性

指标类型：

副作用指标

Outcome：

Safety

Type：

Adverse events

测量时间点：

治疗全程

测量方法：

记录研究期间与针刺或评估相关的不良事件发生情况。

Measure time point of outcome：

Throughout the treatment period

Measure method：

Adverse events related to acupuncture or the assessment procedures during the study period will be recorded.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

本研究不采集人体生物学标本。

Fate of sample：

0thers  

Note：

No human biospecimens will be collected in this study.

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

分层随机分配。采用中心分层区随机分配的方法分组，将随机分配结果通过网络中央随机分配系统发布

Randomization Procedure (please state who generates the random number sequence and by what method)：

Hierarchical random allocation. Grouping is carried out by using the method of random allocation in the central hierarchical area, and the random allocation results are released through the central random allocation system of the network

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

采用二级盲法（双盲）。具体操作为：将随机分配结果通过网络中央随机分配系统发布，患者按患者顺序号及对应的分组结果分配到不同组别即为一级盲底；再将四组用药编号，所有操作过程按照既定SOP完成即为二级盲底。

Blinding：

The two-level blinding method (double-blind) is adopted. The specific operation is as follows: The random allocation results are released through the network central random allocation system. Patients are assigned to different groups according to their patient sequence numbers and corresponding grouping results, which is known as the first-level blind base. If the four groups of medications are numbered and all the operation processes are completed in accordance with the established SOP, it will be called the second-level blind bottom.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

本研究目前无公开共享个体层面原始数据计划。由于研究对象为意识障碍患者，且数据包含临床信息、EEG 及视频行为等敏感资料，个体原始数据不作公开发布。如后续在伦理批准和机构审批条件下开展学术合作，可提供去标识化数据。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

There is currently no plan for public sharing of individual participant data. Because the study involves participants with disorders of consciousness and includes sensitive clinical information, EEG data, and video-behavioral data, individual-level raw data will not be publicly released. De-identified data may be considered for academic collaboration after ethics approval and institutional authorization.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

采用纸质病例报告表（CRF）采集临床资料、量表评分、干预执行情况和不良事件信息，由两名研究人员核对后录入电子数据库。EEG 原始数据、视频行为原始文件及衍生特征数据均采用受试者唯一编号进行去标识化管理，分别存储于受限访问的研究数据文件夹。研究期间定期开展数据质控与逻辑核查，发现缺失或异常数据及时回溯核实；统计分析前完成数据清理和锁库。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Clinical data, scale scores, treatment implementation records, and adverse events will be collected using paper case report forms (CRFs) and entered into an electronic database after verification by two study staff members. Raw EEG files, raw video-behavioral files, and derived feature data will be managed in a de-identified manner using unique participant IDs and stored in restricted-access research data folders. Regular data quality control and logic checks will be performed during the study, and missing or abnormal data will be traced and verified in a timely manner. Data cleaning and database lock will be completed before statistical analysis.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-04-13 14:56:04