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

Official title

Efficacy and Safety of Transcutaneous Electrical Acupoint Stimulation at Hand Jing-Well Points in Patients With Disorders of Consciousness：A Multicenter Randomized Controlled Trial

Overview

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.

Interventions

• Device Transcutaneous electrical stimulation
  Transcutaneous electrical acupoint stimulation at hand twelve jing-well points
• Device Sham electrical stimulation
  Sham electrical acupoint stimulation at hand twelve jing-well points

Primary outcome measures

• Proportion of consciousness improvement after 14 consecutive days of treatment [Time frame: 14 days after treatment]

Secondary outcome measures (11)

• Changes in Coma Recovery Scale-Revised (CRS-R) scores after 7 days of treatment [Time frame: 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]
• Changes in Coma Recovery Scale-Revised (CRS-R) scores after 14 days of treatment [Time frame: 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]
• Changes in ABCD model classification after 14 days of treatment [Time frame: 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 measured by the Glasgow Outcome Scale-Extended (GOSE) at 6 months after enrollment [Time frame: 6 months after enrollment]
• Incidence of adverse events during 6 months after enrollment [Time frame: 6 months after enrollment]
• Incidence of severe adverse events during 6 months after enrollment [Time frame: 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]
• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Xijing Hospital — Xi'an

Identifiers

NCT: NCT07535593 · KY20262069

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗