The Consciousness Variation of Deep Brain Stimulation (DBS) and Transcranial Magnetic Stimulation (TMS) for Disorders of Consciousness(DOC) Patients in a Large Scale Randomised Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The consciousness variation of DBS and TMS for DOC Patients in a large scale randomised trial (revised-coma recovery scale)
研究概览
简要总结
Aims:To explore the consciousness stimulation role of DBS (Deep Brain Stimulation) and TMS (Transcranial Magnetic Simulation) for DOC (Disorders of Consciousness) patients.
Methods:Seventy-five DOC patients will be randomised into three groups: DBS group, TMS group and Control group. Three months after treatments, the result will be analysed and concluded.
详细描述
To explore the consciousness stimulation role of DBS (Deep Brain Stimulation) and TMS (Transcranial Magnetic Stimulation) for DOC (Disorders of Consciousness) patients. Seventy-five DOC patients will be randomised into three groups: DBS group, TMS group and Control group. These patients will be recorded the conscious level, fMRI (functional magnetic resonance imaging) and EEG evaluation before treatment of research, and three months later the prognosis was also recorded. Finally, the variation of consciousness, prognosis, fMRI and EEG index for three groups will be analyzed and compared. Hopefully, there will be a conclusion for these treatments to DOC patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages 14 to 65 years old;
- •DOC patients, including vegetative state and minimally consciousness state.
- •With normal body temperature, stable vital signs, spontaneous breathing without extra oxygen supply, no tracheotomy using metal trachea cannula, and feasible for magnetic resonance inspectors;
- •Written informed consent from patient families
排除标准
- •History with nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
- •Patients with V-P shunt or ommaya implantation, which may effects magnetic resonance scan signal analysis;
- •Body temperature is abnormal, vital signs is not stable, still need ventilator to support breathing; Plentiful sputum needed suction during MRI scans.
研究组 & 干预措施
DBS group
Besides routine treatment, Doc patients in this group will accepted deep brain stimulation treatment.
干预措施: deep brain stimulation (Device)
TMS group
Besides routine treatment, Doc patients in this group will accepted transcranial magnetic stimulation treatment.
干预措施: transcranial magnetic stimulation (Device)
Control group
This Doc patients will accepted routine treatment.
干预措施: Routine treatment (Other)
结局指标
主要结局
The consciousness variation of DBS and TMS for DOC Patients in a large scale randomised trial (revised-coma recovery scale)
时间窗: 3 months
revised-coma recovery scale(CRS-R)
次要结局
- The conscious index based on EEG(3 months)
- The conscious index based on fMRI(3 months)
研究者
Xuehai Wu
Associate Professor
Huashan Hospital