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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Proportion of consciousness improvement after 14 consecutive days of treatment [Срок оценки: 14 days after treatment]

Вторичные конечные точки (11)

• Changes in Coma Recovery Scale-Revised (CRS-R) scores after 7 days of treatment [Срок оценки: 7 days after treatment]
• Changes in sub scale of Coma Recovery Scale-Revised (CRS-R) scores after 7 days of treatment [Срок оценки: 7 days after treatment]
• Changes in Coma Recovery Scale-Revised (CRS-R) scores after 14 days of treatment [Срок оценки: 14 days after treatment]
• Changes in sub scale of Coma Recovery Scale-Revised (CRS-R) scores after 14 days of treatment [Срок оценки: 14 days after treatment]
• Changes in ABCD model classification after 14 days of treatment [Срок оценки: 14 days after treatment]
• Functional outcomes measured by the Glasgow Outcome Scale-Extended (GOSE) at 3 months after enrollment [Срок оценки: 3 months after enrollment]
• Functional outcomes measured by the Glasgow Outcome Scale-Extended (GOSE) at 6 months after enrollment [Срок оценки: 6 months after enrollment]
• Incidence of adverse events during 6 months after enrollment [Срок оценки: 6 months after enrollment]
• Incidence of severe adverse events during 6 months after enrollment [Срок оценки: 6 months after enrollment]
• Incidence of adverse events prespecified for transcutaneous electrical stimulation during treatment [Срок оценки: 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 [Срок оценки: from the first treatment on Day 1 to the completion of the last treatment on Day 14]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xijing Hospital — Сиань

Идентификаторы

NCT: NCT07535593 · KY20262069

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗