About this trial
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
Qualifiers
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;
Aged between 18 and 72 years, with no gender restriction;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Electrostimulation at the Twelve Hand Jing-Well Points
Treatment groups
Locations
Sponsors and collaborators
The Third People's Hospital of Huizhou
Lead sponsor
Tianjin University of Traditional Chinese Medicine
Collaborator