Randomized Controlled Study of Electroacupuncture Stimulation at Jing-Well Points for Chronic Disorders of Consciousness Based on Multimodal Assessment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 主要终点
- coma recovery scale-revised
研究概览
简要总结
Disorder of consciousness (DOC) is a common complication of severe central nervous system injury. It is defined as prolonged DOC when lasting more than 28 days. About 300,000-800,000 patients are affected worldwide, with an annual mortality rate of 29%-50%, causing a heavy social and family burden.
Although progress has been made in pathophysiology, clinical outcomes remain unsatisfactory, and arousal treatment for DOC is still challenging. Internationally recommended therapies, such as neurotrophic drugs, hyperbaric oxygen and invasive neuromodulation, have side effects or uncertain efficacy.
In traditional Chinese medicine, post-TBI DOC is classified as "shen hun" (mental clouding). Bloodletting at Jing-Well points promotes arousal by regulating qi and blood and unblocking collaterals. Preliminary studies showed it may improve consciousness in DOC patients, but with small samples and short observation periods.
Acupuncture, such as the Xingnao Kaiqiao method, induces arousal by improving cerebral blood flow and activating neural networks. Our team proposed the "Jing-Well point-brain correlation" hypothesis and found that electrostimulation at Jing-Well points improves cognitive function, but lacks standardized assessment and large-sample evidence.
Further research is needed to confirm its efficacy, mechanisms and suitable populations to provide high-quality evidence-based support.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the above diagnostic criteria for pDoC and be diagnosed as Vegetative State (VS) / Unresponsive Wakefulness Syndrome (UWS) or Minimally Conscious State (MCS) based on at least two assessments using the Coma Recovery Scale-Revised (CRS-R);
- •First occurrence of a clearly identified acquired brain injury resulting in pDoC, including traumatic brain injury, intracerebral hemorrhage, or cerebral infarction, with complete clinical records available;
- •No obvious hydrocephalus or severe cerebral atrophy, with a disease course ranging from 28 days to 6 months;
- •Aged between 18 and 72 years, with no gender restriction;
- •No significant cognitive, hearing, or visual impairment prior to onset;
- •Normal premorbid communication ability and no history of neurological or psychiatric disorders that may affect consciousness assessment;
- •Clinically stable and not having participated in other clinical trials within the past 1 months;
- •Written informed consent obtained from the patient's legally authorized representative.
排除标准
- •Patients with consciousness disturbance of unknown etiology;
- •Presence of neurodegenerative diseases, intracranial infections, or brain tumors;
- •Severe cardiac, pulmonary, hepatic, or renal dysfunction, or other serious comorbidities that may increase the risk associated with the intervention;
- •Hemodynamic or respiratory instability, including resting heart rate <40 beats/min or >130 beats/min, oxygen saturation <88%, systolic blood pressure >180 mmHg or <90 mmHg, or mean arterial pressure <65 mmHg or >110 mmHg；
- •Presence of implanted electronic devices that may affect the safety of electrical stimulation, such as cardiac pacemakers or spinal cord stimulators;
- •History of long-term dependence on psychoactive medications;
- •Presence of skin lesions, marked hypersensitivity, or other contraindications at the stimulation sites that preclude the use of hand twelve Jing-well point electrical stimulation;
- •Any other factors that may affect assessment and treatment;
- •Patients with uncontrolled epileptic seizures or status epilepticus;
- •Pregnant female patients.
研究组 & 干预措施
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.
干预措施: Electrostimulation at the Twelve Hand Jing-Well Points (Other)
Electroacupuncture group
Based on routine treatment (the same as the control group), patients received additional electrostimulation at Jing-Well points. A Huatuo electroacupuncture apparatus (model: SDZ-V) was used. Stimulation was applied to bilateral Jing-Well points, with intensity adjusted to produce slight limb movement. Each session lasted 60 minutes, once daily, 6 times per week, for 3 consecutive weeks. Electro-press needles were replaced every two days to prevent infection.
干预措施: Electrostimulation at the Twelve Hand Jing-Well Points (Other)
结局指标
主要结局
coma recovery scale-revised
时间窗: "Baseline"、"After 3 weeks of 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.
coma recovery scale-revised
时间窗: "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.
次要结局
- Full Outline of UnResponsiveness("Baseline"、"After 3 weeks of treatment")
- Mismatch Negativity("Baseline"、"After 3 weeks of treatment")
- P300("Baseline"、"After 3 weeks of treatment")
- Glasgow Outcome Scale-Extended("Baseline"、"After 3 weeks of treatment")
- Disability Rating Scale("Baseline"、"After 3 weeks of treatment")
- Neuron-Specific Enolase("Baseline"、"After 3 weeks of treatment")
- Glasgow Outcome Scale-Extended("Baseline"、"After 3 months")
- Disability Rating Scale("Baseline"、"After 3 months")
- Full Outline of UnResponsiveness("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("Baseline"、"1 month after treatment completion")
- Disability Rating Scale("Baseline";"1 month after treatment completion")
研究者
Lvping Li
Associate Chief Physician
The Third People's Hospital of Huizhou