Disorders of Consciousness Due to Severe Brain InjuryPhase 2/3Wells-DoC IINCT07535593
Transcutaneous Electrical Acupoint Stimulation at Jing-Well Points for Disorders of Consciousness
A Phase 2/3 study testing Transcutaneous electrical stimulation in people with Disorders of Consciousness Due to Severe Brain Injury, run by Xijing Hospital at 1 site in China.
Trial summary
Effective treatment options for disorders of consciousness (DoC) remain limited, and available interventions show heterogeneous efficacy. To date, limited evidences support the use of amantadine and transcranial direct current stimulation in this population. 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?
- Transcutaneous electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to Dec 2028
- Phase
- Phase 2/3
- 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 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 brain injury;
- Epilepsy and seizure
- Unstable vital signs or life-threatening comorbidities
- Implanted devices: including cardiac pacemakers or implantable cardioverter-defibrillators (ICDs), deep brain stimulators, ventriculoperitoneal (VP) shunts, and other indwelling electronic or neurosurgical implants.
- Documented pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi
Wen Jiang, Dr., +86 29 84771319, jiangwen@fmmu.edu.cn
Zhirong Fan, Dr., fzr1601@163.com
About this study
Official title: Efficacy and Safety of Transcutaneous Electrical Acupoint Stimulation at Hand Jing-Well Points in Patients With Disorders of Consciousness：A Multicenter Randomized Controlled Trial
Effective treatment options for disorders of consciousness (DoC) remain limited, and available interventions show heterogeneous efficacy. To date, limited evidences support the use of amantadine and transcranial direct current stimulation in this population.
Bloodletting puncture (BP) at the hand twelve Jing-Well points (HTWPs) has been traditionally used in China as an empirical therapy for DoC; however, its efficacy has not been established by robust clinical evidence. Transcutaneous electrical acupoint stimulation (TEAS) provides a modern, noninvasive alternative for acupoint stimulation. The Wells-DoC trial, a multicenter, randomized, controlled, open-label study with blinded endpoint assessment, provided preliminary evidence that TEAS applied at the hand twelve Jing-Well points was associated with a numerically higher proportion of consciousness improvement in patients with DoC, although the difference did not reach statistical significance. These findings support the need for further evaluation in an adequately powered randomized controlled trial.
Read more
The Wells-DoC II trial is a multicenter, randomized, controlled, double-blind clinical trial designed to evaluate the efficacy and safety of TEAS at the twelve Jing-Well points of the hand in patients with DoC. The primary objective of the Wells-DoC II trial is to determine whether TEAS applied at the twelve Jing-Well points of the hand improves consciousness in adults with DoC. The primary endpoint is the proportion of patients achieving consciousness improvement after 14 consecutive days of treatment, compared between the TEAS group and the sham stimulation (placebo control) group.
The secondary objectives are to assess the effects of TEAS versus sham stimulation on: (1) changes in Coma Recovery Scale-Revised (CRS-R) scores at 7 and 14 days; (2) change in ABCD model classification at day 14; and (3) functional outcomes measured by the Glasgow Outcome Scale-Extended (GOSE) at 3 and 6 months after enrollment.
A total of 160 patients will be recruited over a 28-month period.
- Being tested
- Transcutaneous electrical stimulation, Sham electrical stimulation
- Keywords
- Transcutaneous Electrical Acupoint Stimulation, Hand Jing-Well Points, Disorders of Consciousness
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical stimulationDevice
Transcutaneous electrical acupoint stimulation at hand twelve jing-well points
Sham electrical stimulationDevice
Sham electrical acupoint stimulation at hand twelve jing-well points
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous electrical stimulation group | Experimental | Patients randomized to the treatment group will receive transcutaneous electrical acupoint stimulation at hand twelve jing-well points for 14 consecutive days, twice a day, combined with conventional treatment or rehabilitation for patients with DoC. Receives: Device: Transcutaneous electrical stimulation |
| Sham electrical stimulation group | Sham comparator | Patients randomized to the Sham electrical stimulation group will receive sham electrical acupoint stimulation at hand twelve jing-well points for 14 consecutive days, twice a day, combined with conventional treatment or rehabilitation for patients with DoC. Receives: Device: Sham electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of consciousness improvement after 14 consecutive days of treatment
The primary effectiveness outcome was the proportion of patients with consciousness improvement after 14 consecutive days of treatment, wherein improvements from unresponsive wakefulness syndrome (UWS)/vegetative state (VS) to minimally conscious state (MCS) or emergence from minimally conscious state (EMCS), from MCS minus (MCS-) to MCS plus (MCS+) or EMCS, or from MCS+ to EMCS signify a consciousness improvement. Diagnoses of UWS/VS, MCS (minus or plus) and EMCS were determined based on the presence of specific Coma Recovery Scale-Revised (CRS-R) subscale items, assessed by a trained neurologist. The hierarchical order of consciousness levels from worst to best is UWS/VS, MCS-, MCS+, and EMCS.
Measured: 14 days after treatment
Secondary outcomes (11)
Changes in Coma Recovery Scale-Revised (CRS-R) scores after 7 days of treatment
CRS-R is composed of six subscales: auditory function, visual function, motor function, oromotor function, communication ability, and arousal level. CRS-R score ranges from 0 to 23, with higher scores mean a better outcome.
Measured: 7 days after treatment
Changes in sub scale of Coma Recovery Scale-Revised (CRS-R) scores after 7 days of treatment
CRS-R is composed of six subscales: auditory function, visual function, motor function, oromotor function, communication ability, and arousal level. CRS-R score ranges from 0 to 23, with higher scores mean a better outcome. Each sub scale consists of multiple hierarchically organized questions, with higher scores indicating greater performance.
Measured: 7 days after treatment
Changes in Coma Recovery Scale-Revised (CRS-R) scores after 14 days of treatment
CRS-R is composed of six subscales: auditory function, visual function, motor function, oromotor function, communication ability, and arousal level. CRS-R score ranges from 0 to 23, with higher scores mean a better outcome.
Measured: 14 days after treatment
Changes in sub scale of Coma Recovery Scale-Revised (CRS-R) scores after 14 days of treatment
CRS-R is composed of six subscales: auditory function, visual function, motor function, oromotor function, communication ability, and arousal level. CRS-R score ranges from 0 to 23, with higher scores mean a better outcome. Each sub scale consists of multiple hierarchically organized questions, with higher scores indicating greater performance.
Measured: 14 days after treatment
Changes in ABCD model classification after 14 days of treatment
This model classifies the power spectrum of resting-state EEG data into four categories: A, B, C, and D. Type A exhibit 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: 14 days after treatment
Functional outcomes measured by the Glasgow Outcome Scale-Extended (GOSE) at 3 months after enrollment
Functional outcomes were assessed at 3 months after enrollment using the Glasgow Outcome Scale-Extended (GOSE; range 1-8, where higher scores indicate better functional outcomes).
Measured: 3 months after enrollment
Functional outcomes measured by the Glasgow Outcome Scale-Extended (GOSE) at 6 months after enrollment
Functional outcomes were assessed at 6 months after enrollment using the Glasgow Outcome Scale-Extended (GOSE; range 1-8, where higher scores indicate better functional outcomes).
Measured: 6 months after enrollment
Incidence of adverse events during 6 months after enrollment
The safety outcome was the incidence of adverse events during 6 months after enrollment.
Measured: 6 months after enrollment
Incidence of severe adverse events during 6 months after enrollment
The safety outcome was the incidence of severe adverse events during 6 months after enrollment.
Measured: 6 months after enrollment
Incidence of adverse events prespecified for transcutaneous electrical stimulation during treatment
The following adverse events are prespecified for transcutaneous electrical stimulation applied to the twelve Jing-Well points of the hand, including treatment intolerance: manifested as observable distress responses during stimulation, (e.g., painful facial expressions, moaning, crying, or involuntary head movements); local adverse effects: skin infection (e.g., redness, swelling, suppuration), subcutaneous ecchymosis, and skin burns (e.g., blistering or eschar formation) at stimulation sites; and systemic adverse effects: epileptic seizures temporally associated with the intervention.
Measured: from the first treatment on Day 1 to the completion of the last treatment on Day 14
Incidence of severe adverse events prespecified for transcutaneous electrical stimulation during treatment
The following adverse events are prespecified for transcutaneous electrical stimulation applied to the twelve Jing-Well points of the hand, including treatment intolerance: manifested as observable distress responses during stimulation, (e.g., painful facial expressions, moaning, crying, or involuntary head movements); local adverse effects: skin infection (e.g., redness, swelling, suppuration), subcutaneous ecchymosis, and skin burns (e.g., blistering or eschar formation) at stimulation sites; and systemic adverse effects: epileptic seizures temporally associated with the intervention. Serious adverse events (SAEs) are defined as any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability/incapacity
Measured: from the first treatment on Day 1 to the completion of the last treatment on Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start20 Apr 2026
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535593
- Sponsor's protocol ID
- KY20262069
- Acronym
- Wells-DoC II
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NOT YET DECIDED
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Transcutaneous Electrical Acupoint Stimulation at Hand Jing-Well Points in Patients With Disorders of Consciousness：A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07535593
- Acronym / sponsor ID
- Wells-DoC II / KY20262069
- Keywords
- Transcutaneous Electrical Acupoint Stimulation, Hand Jing-Well Points, Disorders of Consciousness
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 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.
Effective treatment options for disorders of consciousness (DoC) remain limited, and available interventions show heterogeneous efficacy. To date, limited evidences support the use of amantadine and transcranial direct current stimulation in this population.
Bloodletting puncture (BP) at the hand twelve Jing-Well points (HTWPs) has been traditionally used in China as an empirical therapy for DoC; however, its efficacy has not been established by robust clinical evidence. Transcutaneous electrical acupoint stimulation (TEAS) provides a modern, noninvasive alternative for acupoint stimulation. The Wells-DoC trial, a multicenter, randomized, controlled, open-label study with blinded endpoint assessment, provided preliminary evidence that TEAS applied at the hand twelve Jing-Well points was associated with a numerically higher proportion of consciousness improvement in patients with DoC, although the difference did not reach statistical significance. These findings support the need for further evaluation in an adequately powered randomized controlled trial.
The Wells-DoC II trial is a multicenter, randomized, controlled, double-blind clinical trial designed to evaluate the efficacy and safety of TEAS at the twelve Jing-Well points of the hand in patients with DoC. The primary objective of the Wells-DoC II trial is to determine whether TEAS applied at the twelve Jing-Well points of the hand improves consciousness in adults with DoC. The primary endpoint is the proportion of patients achieving consciousness improvement after 14 consecutive days of treatment, compared between the TEAS group and the sham stimulation (placebo control) group.
The secondary objectives are to assess the effects of TEAS versus sham stimulation on: (1) changes in Coma Recovery Scale-Revised (CRS-R) scores at 7 and 14 days; (2) change in ABCD model classification at day 14; and (3) functional outcomes measured by the Glasgow Outcome Scale-Extended (GOSE) at 3 and 6 months after enrollment.
A total of 160 patients will be recruited over a 28-month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous electrical stimulation group | Experimental | Device: Transcutaneous electrical stimulationPatients randomized to the treatment group will receive transcutaneous electrical acupoint stimulation at hand twelve jing-well points for 14 consecutive days, twice a day, combined with conventional treatment or rehabilitation for patients with DoC. |
| Sham electrical stimulation group | Sham comparator | Device: Sham electrical stimulationPatients randomized to the Sham electrical stimulation group will receive sham electrical acupoint stimulation at hand twelve jing-well points for 14 consecutive days, twice a day, combined with conventional treatment or rehabilitation for patients with DoC. |
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 brain injury;
- Epilepsy and seizure
- Unstable vital signs or life-threatening comorbidities
- Implanted devices: including cardiac pacemakers or implantable cardioverter-defibrillators (ICDs), deep brain stimulators, ventriculoperitoneal (VP) shunts, and other indwelling electronic or neurosurgical implants.
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 |
|---|---|---|
| Transcutaneous electrical stimulationTranscutaneous electrical acupoint stimulation at hand twelve jing-well points | Device | Transcutaneous electrical stimulation group |
| Sham electrical stimulationSham electrical acupoint stimulation at hand twelve jing-well points | Device | Sham electrical stimulation group |
Primary outcome
Proportion of consciousness improvement after 14 consecutive days of treatment
Time frame: 14 days after treatment
The primary effectiveness outcome was the proportion of patients with consciousness improvement after 14 consecutive days of treatment, wherein improvements from unresponsive wakefulness syndrome (UWS)/vegetative state (VS) to minimally conscious state (MCS) or emergence from minimally conscious state (EMCS), from MCS minus (MCS-) to MCS plus (MCS+) or EMCS, or from MCS+ to EMCS signify a consciousness improvement. Diagnoses of UWS/VS, MCS (minus or plus) and EMCS were determined based on the presence of specific Coma Recovery Scale-Revised (CRS-R) subscale items, assessed by a trained neurologist. The hierarchical order of consciousness levels from worst to best is UWS/VS, MCS-, MCS+, and EMCS.
11 secondary outcomes
Changes in Coma Recovery Scale-Revised (CRS-R) scores after 7 days of treatment
Time frame: 7 days after treatment
Changes in sub scale of Coma Recovery Scale-Revised (CRS-R) scores after 7 days of treatment
Time frame: 7 days after treatment
Changes in Coma Recovery Scale-Revised (CRS-R) scores after 14 days of treatment
Time frame: 14 days after treatment
Changes in sub scale of Coma Recovery Scale-Revised (CRS-R) scores after 14 days of treatment
Time frame: 14 days after treatment
Changes in ABCD model classification after 14 days of treatment
Time frame: 14 days after treatment
Functional outcomes measured by the Glasgow Outcome Scale-Extended (GOSE) at 3 months after enrollment
Time frame: 3 months after enrollment
Functional outcomes measured by the Glasgow Outcome Scale-Extended (GOSE) at 6 months after enrollment
Time frame: 6 months after enrollment
Incidence of adverse events during 6 months after enrollment
Time frame: 6 months after enrollment
Incidence of severe adverse events during 6 months after enrollment
Time frame: 6 months after enrollment
Incidence of adverse events prespecified for transcutaneous electrical stimulation during treatment
Time frame: from the first treatment on Day 1 to the completion of the last treatment on Day 14
Incidence of severe adverse events prespecified for transcutaneous electrical stimulation during treatment
Time frame: from the first treatment on Day 1 to the completion of the last treatment on Day 14
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 5 Aug 2026.
- Individual participant dataSharing planned: Undecided. NOT YET DECIDED
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Transcutaneous electrical stimulation in people with Disorders of Consciousness Due to Severe Brain Injury, run by Xijing Hospital at 1 site 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Wen Jiang, Dr. (+86 29 84771319, jiangwen@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of consciousness improvement after 14 consecutive days of treatment (time frame: 14 days after 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 5 Aug 2026.