Vagus Nerve Stimulation in Patients With Chronic Consciousness Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change over time of clinical scores on the Coma Recovery Scale - Revised
研究概览
简要总结
Minimally Conscious (MCS) or Vegetative State (VS) are disorders of consciousness which often occur following traumatic brain injury or ischemia. These alterations result most of the time in patients' loss of autonomy and require long years of special care. No efficient therapy to improve patients' consciousness has been found so far. Investigators propose to use vagal nerve stimulation (VNS) to restore cortical activity and patients' embodied self. The investigators' main hypothesis is that VNS will reestablish the thalamo-cortical connectivity leading to an improvement of the consciousness state. To test this hypothesis, investigators will use behavioral measures as well as fMRI, PET scan and EEG to assess brain activity. Patients will be evaluated before and during eight months following implantation of the stimulation device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 60 years old
- •Patients with history of cranial trauma, cerebrovascular accident, or other event leading to cerebral anoxia, suffering of chronic alteration of consciousness (Vegetative State, Minimally Conscious State, akinetic mutism). The diagnostic will be based on clinical scales
- •Patients already having a neurophysiologic checkup (EEG)
- •Patients breathing without invasive help, and who are in a stable medical state
- •Patients with a history of disease of at least 6 months
- •Patients without clinical evolution for several months
- •Patients with social security
- •Patients for whom a family member have signed a written consent
排除标准
- •Patients with tracheotomy
- •Pregnant women
- •Intubated patients
- •Patients with damaged vagus nerves
- •Patients with pre existing neurological conditions other than the one responsible for the consciousness disorder
- •Patients with medical complications
- •Patients suffering of septic infection
- •Patients with a significant dysphagia
- •Patients with dyspnea or shortness of breath
- •Patients with obstructive sleep apnea
- •Patients with any conditions non authorized by the stimulating device manufacturer (Cyberonics)
结局指标
主要结局
Change over time of clinical scores on the Coma Recovery Scale - Revised
时间窗: First assessment one week before implantation second assessment 3 weeks after implantation, then once per week for a month starting one week after the beginning of stimulation; then once a month for 6 months.
The primary outcome will be the change over time of patients' clinical state. Investigators will employ a widely used scale: Coma Recovery Scale - Revised. Patients will be evaluated by the same trained doctor. Results will be analyzed using a within subject design, each patients will be his own control. Investigators predict a progressive improvement after the onset of treatment, compared to the two pre-stimulation evaluations.
次要结局
- PET scan evaluation of brain metabolism (Glucose consumption) changes(One baseline assessment one week before stimulation and a second one after 3 months of stimulation.)
- Monitoring changes of thermal reaction to emotional stimuli(First assessment one week before implantation second assessment 3 weeks after implantation, then once per week for a month starting one week after the beginning of stimulation, then once a month for 6 months.)
- MRI (anisotropy and fibers density) evaluation of anatomo-connectivity changes(First assessment one week before implantation second assessment 3 weeks after implantation and then one, three and six months after the onset of stimulation.)
- fMRI evaluation of bold signal resting state activity and functional connectivity changes(Firsts First assessment one week before implantation second assessment 3 weeks after implantation,, and then one, three and six months after the onset of stimulation.)
- : Monitoring changes of serum free serotonin concentration(First assessment one week before implantation second assessment 3 weeks after implantation, then once per week for a month starting one week after the beginning of stimulation, then once a month for 6 months.)
- Evaluation of brain activity changes using EEG(First assessment one week before implantation second assessment 3 weeks after implantation, then once per week for a month starting one week after the beginning of stimulation, then once a month for 6 months.)
- Monitoring heart rate variability(First assessment one week before implantation second assessment 3 weeks after implantation, then once per week for a month starting one week after the beginning of stimulation, then once a month for 6 months.)