Disorder of ConsciousnessNCT07551076
Electroacupuncture at Jing-Well Points for Chronic Disorders of Consciousness: A Randomized Controlled Study With Multimodal Assessment
A study testing Electrostimulation at the Twelve Hand Jing-Well Points in people with Disorder of Consciousness, run by The Third People's Hospital of Huizhou.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Disorder of Consciousness
- What is being tested?
- Electrostimulation at the Twelve Hand Jing-Well Points
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 23 Dec 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Being tested
- Electrostimulation at the Twelve Hand Jing-Well Points
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrostimulation at the Twelve Hand Jing-Well PointsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Electrostimulation at the Twelve Hand Jing-Well Points |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "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
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.
Measured: "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.
Measured: "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).
Measured: "Baseline";"1 month after treatment completion"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start23 Dec 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third People's Hospital of Huizhou
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Lvping Li, The Third People's Hospital of Huizhou
- Investigators
- Lvping Li, Master, Study director, The Third People's Hospital of Huizhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551076
- Sponsor's protocol ID
- 2026-KY-047-01
- Status last verified
- Aug 2026
- First submitted
- 20 Apr 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Electroacupuncture Stimulation at Jing-Well Points for Chronic Disorders of Consciousness Based on Multimodal Assessment
- ClinicalTrials.gov ID
- NCT07551076
- Acronym / sponsor ID
- 2026-KY-047-01
- Conditions
- Disorder of Consciousness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- The Third People's Hospital of HuizhouUniversity, hospital or other
- Collaborators
- Tianjin University of Traditional Chinese Medicine
- Study start
- 23 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture group | Experimental | Other: Electrostimulation at the Twelve Hand Jing-Well PointsBased 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. |
| Waiting-treatment group | Other | Other: Electrostimulation at the Twelve Hand Jing-Well PointsAll 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. |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrostimulation at the Twelve Hand Jing-Well PointsA 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 | Electroacupuncture group, Waiting-treatment group |
Primary outcome
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.
3 secondary outcomes
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)"
Glasgow Outcome Scale-Extended
Time frame: "Baseline"、"1 month after treatment completion"
Disability Rating Scale
Time frame: "Baseline";"1 month after treatment completion"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lvping Li, Master study director
The Third People's Hospital of Huizhou
Questions about this trial
What is this clinical trial studying?
A study testing Electrostimulation at the Twelve Hand Jing-Well Points in people with Disorder of Consciousness, run by The Third People's Hospital of Huizhou.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lvping Li, Master (13542799020, 4531027@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.