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NCT07551076
Electroacupuncture at Jing-Well Points for Chronic Disorders of Consciousness: A Randomized Controlled Study With Multimodal Assessment
Conditions: Disorder of Consciousness
Sex: All
Ages: 18 Years – 72 Years
Healthy volunteers: No
Phase: NA
Enrollment: 66
Sponsor: The Third People's Hospital of Huizhou
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.
Eligibility Criteria
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 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.
Exclusion Criteria:
* 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 \130 beats/min, oxygen saturation \180 mmHg or \
Source: ClinicalTrials.gov (NCT07551076). StuddyBuddy aggregates publicly available trial information.