Efficacy and Safety of Transcutaneous Electrical Acupoint Stimulation at Hand Jing-Well Points in Patients With Disorders of Consciousness：A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Proportion of consciousness improvement after 14 consecutive days of treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Sham electrical stimulation group
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.
干预措施: Sham electrical stimulation (Device)
Transcutaneous electrical stimulation group
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.
干预措施: Transcutaneous electrical stimulation (Device)
结局指标
主要结局
Proportion of consciousness improvement after 14 consecutive days of treatment
时间窗: 14 days after 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.
次要结局
- 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)
- Functional outcomes measured by the Glasgow Outcome Scale-Extended (GOSE) at 3 months after enrollment(3 months after enrollment)
- Functional outcomes measured by the Glasgow Outcome Scale-Extended (GOSE) at 6 months after enrollment(6 months after enrollment)
- Incidence of adverse events during 6 months after enrollment(6 months after enrollment)
- Incidence of severe adverse events during 6 months after enrollment(6 months after enrollment)
- Incidence of adverse events prespecified for transcutaneous electrical stimulation during treatment(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(from the first treatment on Day 1 to the completion of the last treatment on Day 14)