Efficacy and Safety of Spinal Cord Stimulation in Patients With Disorders of Consciousness: A Multicenter, Double-blind, Randomized Controlled Trail
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Effective rate of awakening
研究概览
简要总结
Investigating the efficacy and safety of spinal cord stimulation for patients with disorders of consciousness.
详细描述
Disorder of Consciousness (DOC) is a highly significant and concerning consequence that frequently ensues various acute brain injuries. The DOC encompasses coma, unresponsive wakefulness syndrome (UWS), also known as persistent vegetative state (PVS), and minimally conscious state (MCS). Currently, the available treatments for arousing patients with DOC are relatively limited, encompassing pharmacotherapy, hyperbaric oxygen therapy, neuromodulation, physical rehabilitation exercises, and traditional Chinese acupuncture. Among these approaches, only amantadine and transcranial direct current stimulation have demonstrated efficacy in DOC patients; however, further extensive validation is still warranted.
In recent years, spinal cord stimulation (SCS) has emerged as a cutting-edge and extensively researched modality for arousal therapy. SCS is a form of neuromodulation therapy primarily utilized for intractable pain, diabetic neuropathy, and muscle spasticity, the therapeutic efficacy of the SCS is both significant and safe. Although preliminary studies have demonstrated the potential of SCS in promoting arousal in patients with DOC, these findings are currently limited to small sample reports. Therefore, this multicenter randomized controlled trial aims to provide robust evidence on the effectiveness of SCS in promoting arousal among patients with DOC, thereby standardizing its clinical application and offering advanced evidence-based medicine for DOC management.
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
This study is being conducted as a double-blind trial, wherein the surgeons, assessors and participants' family members are kept unaware of the assigned research groups. However, it is necessary to inform the physicians responsible for adjustment of stimulation parameters about the allocation of participants. Follow-up assessments of participants after stimulation will be conducted by an independent assessor using standardized evaluation criteria.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between the ages of 18 and 65, experiencing DOC for a duration ranging from 3 months to 1 year following brain disease.
- •Patients diagnosed with DOC as a consequence of traumatic brain injury, hypertensive intracerebral hemorrhage, or severe cerebral infarction.
- •Patients exhibiting stable cerebral anatomy and no need for further cranioplasty or hydrocephalus shunt.
- •Patients in MCS, who fulfill at least one of the following criteria: ① Demonstrating an oriented response to noxious stimuli; ② Exhibiting sustained eye tracking behavior; ③ Displaying purposeful movements; ④ Manifesting comprehension of language or emotions and actions (often observed in specific environments such as when hearing family members crying).
- •The vital signs and state of consciousness are stable: normal body temperature, the spontaneous breathing is stable (minimal sputum production and respiratory stability without oxygen supplementation for at least 2 hours); there is no significant change in the level of consciousness for at least 1 month and more.
- •Presence of short-latency responses (N20/P25) on somatosensory evoked potentials (SEP) recorded from the median nerve in the upper limbs.
- •Written informed consent obtained from legal guardians or representatives.
排除标准
- •Patients with a history of severe neurological or psychiatric disorders, or other significant diseases impacting prognosis prior to the onset of DOC;
- •Patients with contraindications for surgery, such as acute infections or coagulation disorders;
- •Patients who require short-wave diathermy treatment and are unable to undergo neurostimulation;
- •Patients with hypoxic brain injury due to suffocation, cardiac arrest, or respiratory arrest;
- •Patients with brainstem hemorrhage;
- •Pregnant women;
- •Patients who voluntarily request SCS implantation but are unwilling to cooperate with the research protocol;
- •Participants in other clinical trials.
结局指标
主要结局
Effective rate of awakening
时间窗: SCS stimulation for 3 months after operation
The CRS-R is employed, with a minimum of 5 CRS-R assessments conducted at each follow-up time point, accompanied by simultaneous video recording. And the highest value is scored as a state of consciousness. The clinical assessment of participants' consciousness is deemed significantly improved when it fulfills the following criteria: a) MCS- recover to consciousness level of MCS+ or higher; b) MCS status (MCS- or MCS+) recover to emergence from MCS (restoration of functional communication).
次要结局
- The difference of modified Ashworth scale relative to baseline between SCS group and Sham group(SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation)
- The difference of effective rate of awakening between SCS group and Sham group by SECONDs scale(SCS stimulation for 6-month-postoperative-stimulation)
- SCS stimulation for 6-month-postoperative-stimulation, the difference of effective rate of awakening between SCS group and Sham group by CRS-R scale(SCS stimulation for 6-month-postoperative-stimulation)
- The difference of CRS-R scale relative to baseline between SCS group and Sham group(SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation)
- The difference of SECONDs scale relative to baseline between SCS group and Sham group(SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation)
- The NCS-R scale relative to baseline between SCS group and Sham group(SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation)
- The difference of recovery trajectories of consciousness level between SCS group and Sham group(SCS stimulation for 6-month-postoperative-stimulation)
- The difference of effective rate of awakening of 3 month s of sham stimulation and 3 month s of SCS stimulation in Sham group(6-month-postoperation)
研究者
Xuehai Wu
Deputy Director of Shanghai Neurosurgical Emergency Center
Huashan Hospital