Transcutaneous Electrical Acupoint Stimulation at Jing-Well Points for Disorders of Consciousness (Wells-DoC II)

April 14, 2026 updated by: Xijing Hospital

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Zhirong Fan, Dr.
  • Phone Number: +86 29 84771319
  • Email: fzr1601@163.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous electrical stimulation group
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.
Device: Transcutaneous electrical stimulation
Transcutaneous electrical acupoint stimulation at hand twelve jing-well points
Sham Comparator: Sham electrical stimulation group
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.
Device: Sham electrical stimulation
Sham electrical acupoint stimulation at hand twelve jing-well points

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Coma Recovery Scale-Revised (CRS-R) scores after 7 days of treatment
Time Frame: 7 days after 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.
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
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.
7 days after treatment
Changes in Coma Recovery Scale-Revised (CRS-R) scores after 14 days of treatment
Time Frame: 14 days after 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.
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
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.
14 days after treatment
Changes in ABCD model classification after 14 days of treatment
Time Frame: 14 days after 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.
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 were assessed at 3 months after enrollment using the Glasgow Outcome Scale-Extended (GOSE; range 1-8, where higher scores indicate better functional outcomes).
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
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).
6 months after enrollment
Incidence of adverse events during 6 months after enrollment
Time Frame: 6 months after enrollment
The safety outcome was the incidence of adverse events during 6 months after enrollment.
6 months after enrollment
Incidence of severe adverse events during 6 months after enrollment
Time Frame: 6 months after enrollment
The safety outcome was the incidence of severe adverse events during 6 months after enrollment.
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
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.
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
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
from the first treatment on Day 1 to the completion of the last treatment on Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20262069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NOT YET DECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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