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

N/ANot Yet RecruitingNCT07551076

The Third People's Hospital of Huizhou66 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Disorder of Consciousness

Eligibility

Sex: ALLMin age: 18 YearsMax age: 72 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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)"

Secondary Outcomes

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.

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)"

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.

Time frame: "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).

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