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 (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)"

Secondary Outcomes (3)

• 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"

Other Outcomes (3)

• Mismatch Negativity

  "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)"

• P300

  "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)"

• Neuron-Specific Enolase

  "Baseline (Day 0, pre-first treatment)";"Day 20 post-enrollment (post all 18 treatments, end of 3-week treatment)"

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 at the end of the follow-up period.

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 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.

You may not qualify if:

• 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.

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: July 23, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share