Hand Jing-Well Points Stimulation to Treat Disorders of Consciousness (Wells-DoC)

July 13, 2026 updated by: Xijing Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital
      • Xi'an, Shaanxi, China, 710068
        • Shaanxi Provincial People's Hospital
      • Xi'an, Shaanxi, China, 710038
        • Xi'an TCM Hospital of Encephalopathy
      • Xi'an, Shaanxi, China, 710100
        • Xi'an International Medical Center Hospita

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 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

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bloodletting Puncture
Bloodletting puncture at hand twelve jing-well points for 5 consecutive days, once a day, combined with conventional medical treatment.
Other: Bloodletting Acupuncture
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).
Experimental: Transcutaneous electrical stimulation
Transcutaneous electrical acupoint stimulation at hand twelve jing-well points for 5 consecutive days, once a day, combined with conventional medical treatment.
Device: Transcutaneous electrical stimulation
Transcutaneous electrical acupoint stimulation at hand twelve jing-well points.
No Intervention: Control
Control group was treated with conventional medical treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline, immediately after the end of the 5-day treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ABCD model change
Time Frame: baseline, immediately after the end of the 5-day treatment
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.
baseline, immediately after the end of the 5-day treatment
ABCD model change
Time Frame: baseline, immediately after the end of the first treatment
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.
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
CRS-R score ranges from 0 to 23, with higher scores mean a better outcome.
baseline, immediately after the end of the first treatment
Incidence of Adverse Events
Time Frame: from the first treatment to the end of the fifth treatment
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。
from the first treatment to the end of the fifth treatment
Glasgow Outcome Scale-Extended (GOSE)
Time Frame: at six months post enrollment
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.
at six months post enrollment
Consciousness level change
Time Frame: baseline, at six months post enrollment
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.
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
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.
on the first day, the fifth day and at six months post enrollment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Coma Recovery Scale-Revised (CRS-R)
Time Frame: Immediately after the first treatment
CRS-R score ranges from 0 to 23, with higher scores mean a better outcome.
Immediately after the first treatment
ABCD model
Time Frame: Immediately after the first treatment
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.
Immediately after the first treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 26, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY20252094JIANGWEN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data are available in the main text.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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