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NCT07551076

PHASE3

Electroacupuncture at Jing-Well Points for Chronic Disorders of Consciousness: A Randomized Controlled Study With Multimodal Assessment

Sponsor: The Third People's Hospital of Huizhou

View on ClinicalTrials.gov

Summary

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.

Official title: Randomized Controlled Study of Electroacupuncture Stimulation at Jing-Well Points for Chronic Disorders of Consciousness Based on Multimodal Assessment

Key Details

Gender

All

Age Range

18 Years - 72 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-05-30

Completion Date

2027-03-01

Last Updated

2026-04-24

Healthy Volunteers

Conditions

Disorder of Consciousness

Interventions

OTHER

Electrostimulation at the Twelve Hand 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.

Inclusion Criteria: * 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 onset of impaired consciousness with a clear etiology (traumatic brain injury / intracerebral hemorrhage / cerebral infarction) and a complete medical history; * No obvious hydrocephalus or severe cerebral atrophy, with a disease course ranging from 28 days to 6 months; ④ Aged between 18 and 72 years, with no gender restriction; * No significant cognitive, hearing, or visual impairment prior to onset; ⑥ Able to communicate accurately in Chinese before onset, with no history of major neurological or psychiatric disorders; ⑦ Clinically stable and not having participated in other clinical trials within the past 3 months; ⑧ Informed consent signed by the patient's family member or legal representative. Exclusion Criteria: * Patients with consciousness disturbance of unknown etiology; * Patients in coma due to neurodegenerative diseases, intracranial infection, or after brain tumor surgery; * Patients with severe complications; * Heart rate exceeding 70% of the age-predicted maximum heart rate, a decrease of \>20% from resting heart rate, \<40 beats/min, or \>130 beats/min; * Blood oxygen saturation \<88%; systolic blood pressure \>180 mmHg, or presence of orthostatic hypotension, mean arterial pressure \<65 mmHg or \>110 mmHg; * Patients with metallic implants such as cardiac pacemakers or spinal cord stimulators; ⑦ History of substance abuse prior to onset; * Patients with hyperalgesia in the stimulation area who are not suitable for electrostimulation at Jing-Well points; * Any other factors that may affect assessment and treatment; ⑩ Patients with uncontrolled epileptic seizures or status epilepticus; ⑪ Patients in whom ERP cannot be measured at the corresponding sites due to skull defects or other reasons; ⑫ Pregnant female patients.