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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Disorder of Consciousness
• Intervention / Treatment: Other: Electrostimulation at the Twelve Hand Jing-Well Points

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lvping Li, Master; Phone Number: 13542799020; Email: 4531027@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;
• 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.

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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electroacupuncture group; 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; 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: Waiting-treatment group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full Outline of UnResponsiveness	The FOUR Score was developed as a supplement and refinement to the Glasgow Coma Scale (GCS), and is particularly suitable for assessing patients with severely impaired consciousness or those receiving sedation or intubation in intensive care settings. It consists of four assessment dimensions, evaluating neurological functions including eye response, motor response, brainstem reflexes, and respiratory pattern. Each dimension is scored up to 4 points, with a total score ranging from 0 to 16; lower scores indicate worse neurological status.	"Baseline"、"After 3 weeks of treatment"
Mismatch Negativity	MMN (mismatch negativity) is an auditory evoked potential that reflects the brain's ability to automatically analyze and process sensory information, namely the pre-attentive processing. It can be used to assess the integrity of the brain's sensory processing system and help determine the conscious state and prognosis of patients with disorders of consciousness (DOC). Changes in its amplitude and latency are correlated with the likelihood of consciousness recovery, and patients with higher amplitude and shorter latency have a relatively greater chance of regaining consciousness.	"Baseline"、"After 3 weeks of treatment"
P300	P300, like MMN, is also an event-related potential that does not require active movement from the patient, but reflects a higher-order attention-cognitive processing mechanism. Whereas MMN is responsible for pre-attentive automatic detection of deviant stimuli, P300 represents the engagement of conscious attentional resources and the updating of working memory. Therefore, in the assessment of patients with prolonged disorders of consciousness (pDoC), P300 provides information at the consciousness-related level rather than the pre-attentive level, and can be used to determine whether patients retain top-down cognitive processing abilities.	"Baseline"、"After 3 weeks of treatment"
Neuron-Specific Enolase	NSE is a marker enzyme of neurons. Following craniocerebral injury, changes in serum levels of this biomarker can reflect damage and recovery of nerve cells. Monitoring protein levels of NSE may provide clues to the biological mechanisms underlying consciousness recovery.	"Baseline"、"After 3 weeks of treatment"
Glasgow Outcome Scale-Extended	GOSE scores were categorized into favorable outcome (GOSE score 4-8) and unfavorable outcome (GOSE score 1-3). Participants (or their informants) were asked to report dysfunction in six major life domains: independence at home, independence outside the home, work functioning, social/leisure functioning, relationship problems, and other problems affecting daily life.	"Baseline"、"After 3 months"
Disability Rating Scale	The Disability Rating Scale (DRS) has a broader focus. It is designed to measure the severity of disability following brain injury and its changes over time, covering the entire continuum from coma to community reintegration. It consists of four assessment stages, which evaluate arousal, consciousness and responsiveness, cognitive abilities, functional dependence, and psychosocial adaptation in a staged manner. The total score ranges from 0 (no disability) to 29 (vegetative state) or 30 (death).	"Baseline"、"After 3 months"

Collaborators and Investigators

• Sponsor: The Third People's Hospital of Huizhou
• Collaborators: Tianjin University of Traditional Chinese Medicine
• Investigators: Study Director: Lvping Li, Master, The Third People's Hospital of Huizhou

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Consciousness Disorders
• Other Study ID Numbers: 2026-KY-047-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No