Transcutaneous Electrical Acupoint Stimulation at Jing-Well Points for Disorders of Consciousness

NCT07535593 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: KY20262069
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Disorders of Consciousness Due to Severe Brain Injury

Keywords

Transcutaneous Electrical Acupoint Stimulation; Hand Jing-Well Points; Disorders of Consciousness

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days after treatment

Secondary Outcomes (11)

• Changes in Coma Recovery Scale-Revised (CRS-R) scores after 7 days of treatment

  7 days after treatment

• Changes in sub scale of Coma Recovery Scale-Revised (CRS-R) scores after 7 days of treatment

  7 days after treatment

• Changes in Coma Recovery Scale-Revised (CRS-R) scores after 14 days of treatment

  14 days after treatment

• Changes in sub scale of Coma Recovery Scale-Revised (CRS-R) scores after 14 days of treatment

  14 days after treatment

• Changes in ABCD model classification after 14 days of treatment

  14 days after treatment

Study Arms (2)

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.

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.

Device: Sham electrical stimulation

Interventions

Transcutaneous electrical stimulation DEVICE

Transcutaneous electrical acupoint stimulation at hand twelve jing-well points

Transcutaneous electrical stimulation group

Sham electrical stimulation DEVICE

Sham electrical acupoint stimulation at hand twelve jing-well points

Sham electrical stimulation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, China

Location

MeSH Terms

Conditions

Consciousness Disorders

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Wen Jiang, Dr.

CONTACT

+86 29 84771319; jiangwen@fmmu.edu.cn

Zhirong Fan, Dr.

CONTACT

+86 29 84771319; fzr1601@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study members are blinded to randomization except the following: electrical stimulation operators in each investigation site. Electrical stimulation operators are independent of all other components of the trial and are responsible for participant randomization as well as the administration of both active TEAS and sham interventions. Consequently, they are aware of treatment allocation. To minimize bias, they will not be involved in outcome assessment, data collection beyond the intervention procedures, or statistical analysis, and will be required to maintain strict confidentiality regarding group assignments throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CN (1)