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Completed

NCT Number: NCT06927713

Hand Jing-Well Points Stimulation to Treat 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.

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Key information

Conditions

Disorders of Consciousness Due to Severe Brain Injury

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaanxi Provincial People's Hospital, Xi'an, Shaanxi, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bloodletting Acupuncture

Other

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 stimulation

Device

Transcutaneous electrical acupoint stimulation at hand twelve jing-well points.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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。

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study 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

Acronym: Wells-DoC

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 15, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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