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NCT Number: NCT07551076

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

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Key information

Conditions

Disorder of Consciousness Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. coma recovery scale-revised

    Time frame: "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)"

    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.

Secondary outcomes

  1. Full Outline of UnResponsiveness

    Time frame: "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)"

    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.

  2. Glasgow Outcome Scale-Extended

    Time frame: "Baseline"、"1 month after treatment completion"

    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.

  3. Disability Rating Scale

    Time frame: "Baseline";"1 month after treatment completion"

    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).

Other outcomes

  1. Mismatch Negativity

    Time frame: "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)"

    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.

  2. P300

    Time frame: "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, 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.

  3. Neuron-Specific Enolase

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lvping Li, Master

CONTACT

[email protected]

13542799020

Sponsors and collaborators

Lead sponsor

The Third People's Hospital of Huizhou

Other

Collaborators

  • Tianjin University of Traditional Chinese Medicine

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 24, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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