Disorders of Consciousness Due to Severe Brain InjuryWells-DoCNCT06927713
Hand Jing-Well Points Stimulation to Treat Disorders of Consciousness
A study testing Bloodletting Acupuncture and Transcutaneous electrical stimulation in people with Disorders of Consciousness Due to Severe Brain Injury, run by Xijing Hospital at 4 sites in China.
Trial summary
The purpose of this academic lead study is to explore the ideal stimulation strategies at Hand twelve jing-well points in patients with disorders of consciousness. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Disorders of Consciousness Due to Severe Brain Injury
- What is being tested?
- Bloodletting Acupuncture and Transcutaneous electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 4 sitesChina
- Study dates
- 12 May 2025to 26 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-80 years old
- From 7 to 90 days since brain injury
- Diagnosed in VS/UWS or MCS as defined by at least two CRS-R assessments performed during the screening period
- Acquired cerebral damage of known etiology
- Intact hand skin
- Informed consent given by the legal surrogate
Who cannot join
- Patients who continuously receive sedative drugs and Na+ or Ca2+ channel blockers (e.g., carbamazepine) or NMDA receptor antagonists (e.g., dextromethorphan)
- History of previous serious、progressive neurological disorder prior to the brian injury
- Epilepsy and seizure
- Unstable vital signs or life-threatening comorbidities
- Active implant (e.g., cardiac pacemakers/defibrillators, deep brain stimulators, ventriculoperitoneal shunt, etc)
- Documented pregnancy
Trial locations and contacts
4 sites in 1 country.
China4 sites
Xijing Hospital
Xi'an, Shaanxi, 710032
Xi'an TCM Hospital of Encephalopathy
Xi'an, Shaanxi, 710038
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068
Xi'an International Medical Center Hospita
Xi'an, Shaanxi, 710100
About this study
Official title: A Multi-center Randomised Controlled Trial to Explore the Ideal Stimulation Strategies at Hand Twelve Jing-Well Points in Patients With Disorders of Consciousness
The purpose of this academic lead study is to explore the ideal stimulation strategies at Hand twelve jing-well points in patients with disorders of consciousness.
- Being tested
- Bloodletting Acupuncture, Transcutaneous electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bloodletting AcupunctureOther
Bloodletting was applied to the right hand first and then the left hand in the order of Shaoshang (LU 11), Shangyang (LI 1), Zhongchong (PC 9), Guanchong (TE 1), Shaochong (HT 9) and Shaoze (SI 1).
Transcutaneous electrical stimulationDevice
Transcutaneous electrical acupoint stimulation at hand twelve jing-well points.
| Study group | Role | What they receive |
|---|---|---|
| Bloodletting Puncture | Experimental | Bloodletting puncture at hand twelve jing-well points for 5 consecutive days, once a day, combined with conventional medical treatment. Receives: Other: Bloodletting Acupuncture |
| Transcutaneous electrical stimulation | Experimental | Transcutaneous electrical acupoint stimulation at hand twelve jing-well points for 5 consecutive days, once a day, combined with conventional medical treatment. Receives: Device: Transcutaneous electrical stimulation |
| Control | No intervention | Control group was treated with conventional medical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coma Recovery Scale-Revised (CRS-R) change
CRS-R score ranges from 0 to 23, with higher scores mean a better outcome.
Measured: baseline, immediately after the end of the 5-day treatment
Secondary outcomes (7)
ABCD model change
This model classifies the power spectrum of resting-state EEG data into four categories: A, B, C, and D. Type A exhibits a power spectrum peak in the delta range (0-4 Hz), indicative of a completely disconnected thalamocortical network. Type B shows a primary power spectrum peak in the theta range (4-8 Hz), reflecting a severely disconnected thalamocortical network. Type C exhibits power spectrum peaks in both the theta (4-8 Hz) and beta (13-24 Hz) ranges, indicative of a moderately disconnected thalamocortical network. Type D shows power spectrum peaks in the alpha (8-13 Hz) and beta ranges, representing a fully intact thalamocortical network.
Measured: baseline, immediately after the end of the 5-day treatment
ABCD model change
This model classifies the power spectrum of resting-state EEG data into four categories: A, B, C, and D. Type A exhibits a power spectrum peak in the delta range (0-4 Hz), indicative of a completely disconnected thalamocortical network. Type B shows a primary power spectrum peak in the theta range (4-8 Hz), reflecting a severely disconnected thalamocortical network. Type C exhibits power spectrum peaks in both the theta (4-8 Hz) and beta (13-24 Hz) ranges, indicative of a moderately disconnected thalamocortical network. Type D shows power spectrum peaks in the alpha (8-13 Hz) and beta ranges, representing a fully intact thalamocortical network.
Measured: baseline, immediately after the end of the first treatment
Coma Recovery Scale-Revised (CRS-R) change
CRS-R score ranges from 0 to 23, with higher scores mean a better outcome.
Measured: baseline, immediately after the end of the first treatment
Glasgow Outcome Scale-Extended (GOSE)
A GOSE score of 1 indicates death, 2 indicates a vegetative state, 3 to 4 indicates severe disability, 5 to 6 indicates moderate disability, and 7 to 8 indicates good recovery. Favorable functional outcome is defined as an GOSE score of 4-8, while unfavorable functional outcome is defined as an GOSE score of 1-3.
Measured: at six months post enrollment
Consciousness level change
The level of consciousness was evaluated using CRS-R score. Patients who transitioned from UWS to MCS (UWS-MCS) or to emergence from MCS (EMCS) (UWS-EMCS), from MCS minus to MCS plus (MCS - -MCS + ) or to EMCS (MCS - -EMCS), and from MCS to EMCS (MCS-EMCS) were categorized in the improved consciousness group. The unimproved consciousness was defined as a reduced or unchanged level of consciousness.
Measured: baseline, at six months post enrollment
Correlation between EEG responsiveness and long-term outcomes
EEG responsiveness to the treatment was considered positive if, after the hand Jing-Well points stimulation, patients exhibited elevated levels of EEG "ABCD" patterns compared to the baseline after either the first or fifth stimulation session. The correlation between EEG responsiveness and long-term consciousness improvement and favorable functional outcome was assessed.
Measured: on the first day, the fifth day and at six months post enrollment
Incidence of Adverse Events
The incidence of adverse events occurred during the intervention period, including treatment intolerance：painful facial expressions, moans, crying, and head movements；Local adverse effect：skin infections (redness, swelling, suppuration), subcutaneous ecchymosis, skin burns (blisters or eschar formation)；Systemic adverse effect：epileptic seizures。
Measured: from the first treatment to the end of the fifth treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start12 May 2025
- Primary completion26 Dec 2025
- Study completion26 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of Consciousness Due to Severe Brain InjuryStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927713
- Sponsor's protocol ID
- KY20252094JIANGWEN
- Acronym
- Wells-DoC
- Status last verified
- Jun 2026
- First submitted
- 30 Mar 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data are available in the main text.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Randomised Controlled Trial to Explore the Ideal Stimulation Strategies at Hand Twelve Jing-Well Points in Patients With Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT06927713
- Acronym / sponsor ID
- Wells-DoC / KY20252094JIANGWEN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 26 Dec 2025 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 15 Apr 2025 (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.
The purpose of this academic lead study is to explore the ideal stimulation strategies at Hand twelve jing-well points in patients with disorders of consciousness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bloodletting Puncture | Experimental | Other: Bloodletting AcupunctureBloodletting puncture at hand twelve jing-well points for 5 consecutive days, once a day, combined with conventional medical treatment. |
| Transcutaneous electrical stimulation | Experimental | Device: Transcutaneous electrical stimulationTranscutaneous electrical acupoint stimulation at hand twelve jing-well points for 5 consecutive days, once a day, combined with conventional medical treatment. |
| Control | No intervention | –Control group was treated with conventional medical treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18-80 years old
- From 7 to 90 days since brain injury
- Diagnosed in VS/UWS or MCS as defined by at least two CRS-R assessments performed during the screening period
- Acquired cerebral damage of known etiology
- Intact hand skin
Key exclusion criteria (6 listed)
- Patients who continuously receive sedative drugs and Na+ or Ca2+ channel blockers (e.g., carbamazepine) or NMDA receptor antagonists (e.g., dextromethorphan)
- History of previous serious、progressive neurological disorder prior to the brian injury
- Epilepsy and seizure
- Unstable vital signs or life-threatening comorbidities
- Active implant (e.g., cardiac pacemakers/defibrillators, deep brain stimulators, ventriculoperitoneal shunt, etc)
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 |
|---|---|---|
| Bloodletting AcupunctureBloodletting was applied to the right hand first and then the left hand in the order of Shaoshang (LU 11), Shangyang (LI 1), Zhongchong (PC 9), Guanchong (TE 1), Shaochong (HT 9) and Shaoze (SI 1). | Other | Bloodletting Puncture |
| Transcutaneous electrical stimulationTranscutaneous electrical acupoint stimulation at hand twelve jing-well points. | Device | Transcutaneous electrical stimulation |
Primary outcome
Coma Recovery Scale-Revised (CRS-R) change
Time frame: baseline, immediately after the end of the 5-day treatment
CRS-R score ranges from 0 to 23, with higher scores mean a better outcome.
7 secondary outcomes
ABCD model change
Time frame: baseline, immediately after the end of the 5-day treatment
ABCD model change
Time frame: baseline, immediately after the end of the first treatment
Coma Recovery Scale-Revised (CRS-R) change
Time frame: baseline, immediately after the end of the first treatment
Glasgow Outcome Scale-Extended (GOSE)
Time frame: at six months post enrollment
Consciousness level change
Time frame: baseline, at six months post enrollment
Correlation between EEG responsiveness and long-term outcomes
Time frame: on the first day, the fifth day and at six months post enrollment
Incidence of Adverse Events
Time frame: from the first treatment to the end of the fifth treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Yes. All data are available in the main text.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bloodletting Acupuncture and Transcutaneous electrical stimulation in people with Disorders of Consciousness Due to Severe Brain Injury, run by Xijing Hospital at 4 sites in China.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coma Recovery Scale-Revised (CRS-R) change (time frame: baseline, immediately after the end of the 5-day 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 15 Jul 2026.