Electro-acupuncture to Treat Disorder of Consciousness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Coma Recovery Scale - Revised score
研究概览
简要总结
With the rapid development of life support technology, more and more people can survive severe brain injury. Some survivors regain consciousness after a period of coma, however, many patients develop prolonged disorders of consciousness (DOC), which poses a therapeutic challenge for clinicians and a heavy burden for their families. The investigators design an Electro-acupuncture to treat disorder of consciousness (AcuDoc) trial with the aim of validating the clinical effect of electroacupuncture in treating DOC and exploring its therapeutic mechanisms by integrating EEG, neuroimaging, evoked potential tests, and behavioral assessments.
详细描述
The AcuDoc trial is a single-center, prospective, triple masking, randomized, sham electroacupuncture-controlled study. A total of 50 adult patients with DOC and 25 healthy subjects will be enrolled in the study . Patients will be randomized into electroacupuncture (EA) group or sham EA group (1:1). All patients will receive EA or sham-EA treatment in the supine position at 9 am for 30 minutes once a day for consecutive 14 days and healthy subjects will receive no treatments. The primary objective is to determine the therapeutic benefit of electroacupuncture on the recovery of consciousness in patients with DOC after a 2-week intervention. Key secondary objective is to investigate the effect of electroacupuncture on the circuitry of consciousness using a multimodal approach integrating EEG, neuroimaging (rs-fMRI, amide proton transfer imaging, intravoxel incoherent motion imaging, neurite orientation dispersion and density imaging), and evoked potentials (SEP, BAEP). Other secondary outcomes include the effect of EA on the assessment of brain-computer interface after a 2-week intervention and on the Glasgow Outcome Scale-Extended score at 30 days and 90 days .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years;
- •With cerebral damage due to TBI；
- •Diagnosed with UWS or MCS based on at least two CRS-R assessments;
- •From 4 to 16 weeks from the onset of brain injury;
- •Informed consent obtained.
排除标准
- •With a history of neurological or psychiatric disorder prior to the brain injury;
- •With uncontrolled seizures or status epilepticus;
- •Unstable vital signs and requiring the use of vasoactive agents;
- •With the use of general anesthetics or central acting sedative;
- •Without intact skin at acupoints or sham points;
- •Concomitant medical illness that would interfere with the outcome assessments and/or follow-up
- •Pregnant patients;
- •Currently participating in other investigational trials;
- •High likelihood of not adhering to the study treatment or the follow-up regimen
研究组 & 干预措施
Electro-acupuncture group
Patients in EA group receive acupuncture at Shuigou (also known as Renzhong, GV26) and Yintang (updated number GV24+, previous number GV29). Paired electrodes from the EA apparatus are clipped to the needle handles at Shuigou and Yintang. The electroacupuncture stimulation lasts for 30 minutes with a wave of rarefaction and condensation (10 Hz / 50 Hz) and a current intensity of the maximum withstand current within 7mA. All patients receive EA at 9 am for 30 minutes once a day for consecutive 14 days.
干预措施: Electroacupuncture (Other)
Sham electro-acupuncture group
Patients in sham-EA group receive sham-EA at sham-Shuigou and sham-Yintang.Acupuncture needles are inserted into the adhesive pads but do not pierce the skin. Paired electrodes from the EA apparatus via sham connecting cords are clipped to the needle handles at sham-Shuigou and sham-Yintang. The sham connecting cords are similar in appearance to the normal ones, but the inner wires in sham connecting cords are cut off and cannot conduct electricity. All patients receive sham-EA at 9 am for 30 minutes once a day for consecutive 14 days.
干预措施: Sham electroacupuncture (Other)
结局指标
主要结局
Coma Recovery Scale - Revised score
时间窗: after 14 days of EA or sham-EA treatment
0 - 23, a higher score indicates a better level of consciousness
次要结局
- phase locking value(after 14 days of EA or sham-EA treatment)
- amplitude of low-frequency fluctuation(after 14 days of EA or sham-EA treatment)
- neurite density index(after 14 days of EA or sham-EA treatment)
- Glasgow Outcome Scale-Extended score(90 days after randomization)
- f value(after 14 days of EA or sham-EA treatment)
- brain-computer interface accuracy(after 14 days of EA or sham-EA treatment)
- latency value of N20(after 14 days of EA or sham-EA treatment)
- Amide proton transfer-weighted signal(after 14 days of EA or sham-EA treatment)
- latency between III and V potentials(after 14 days of EA or sham-EA treatment)
研究者
Fang Yuan
Principal Investigator
The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine