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 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 <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.

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 at the end of the follow-up period.	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 (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 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 (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	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"、"1 month after treatment completion"
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";"1 month after treatment completion"

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (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	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 (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	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 (Day 0, pre-first treatment)";"Day 20 post-enrollment (post all 18 treatments, end of 3-week treatment)"

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): December 23, 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): September 2, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: August 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