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

Air Force Military Medical University of People's Liberation Army

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Disorders of Consciousness Due to Severe Brain Injury

Treatments: Device: Sham electrical stimulation; Device: Transcutaneous electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07535593

KY20262069

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups

Transcutaneous electrical stimulation group

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous electrical stimulation

Sham electrical stimulation group

Sham Comparator group

Description:

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.

Treatment:

Device: Sham electrical stimulation