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

NCT07551076 | Not Yet Recruiting

• 1 other identifier: 2026-KY-047-01
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Disorder of Consciousness

Outcome Measures

Primary Outcomes (1)

• coma recovery scale-revised

  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.

  "Baseline"、"After 3 weeks of treatment"

Secondary Outcomes (6)

• 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 months"

• Disability Rating Scale

  "Baseline"、"After 3 months"

Study Arms (2)

Electroacupuncture group

EXPERIMENTAL

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.

Other: Electrostimulation at the Twelve Hand Jing-Well Points

Waiting-treatment group

OTHER

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 after 3 weeks of synchronous observation.

Other: Electrostimulation at the Twelve Hand Jing-Well Points

Interventions

Electrostimulation at the Twelve Hand Jing-Well Points OTHER

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.

Electroacupuncture group; Waiting-treatment group

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• No significant cognitive, hearing, or visual impairment prior to onset;
• Able to communicate accurately in Chinese before onset, with no history of major neurological or psychiatric disorders;
• Clinically stable and not having participated in other clinical trials within the past 3 months;
• Informed consent signed by the patient's family member or legal representative.

You may not qualify if:

• 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;
• 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;
• Patients with uncontrolled epileptic seizures or status epilepticus;
• Patients in whom ERP cannot be measured at the corresponding sites due to skull defects or other reasons;
• Pregnant female patients.

Sponsors & Collaborators

• The Third People's Hospital of Huizhou: lead
• Tianjin University of Traditional Chinese Medicine: collaborator

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lvping Li, Master

  The Third People's Hospital of Huizhou

  STUDY DIRECTOR

Central Study Contacts

Lvping Li, Master

CONTACT

13542799020; 4531027@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share