Neurophysiological Effects of tPCS and tDCS on Patients With Disorders of Consciousness
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Signal coherence and EEG power as measured by Quantitative electroencephalographic analysis (qEEG)
研究概览
简要总结
This study aims at comparing the effects of transcranial direct current stimulation and transcranial pulsed current stimulation on neurophysiological outcomes on patients with disorders of consciousness. This study also aims to evaluate the effects of these techniques on patients' level of consciousness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fluent in English or French
- •Legally authorized surrogate available to provide informed consent
- •History of non-traumatic brain injury with loss of consciousness caused by stroke, cerebral hemorrhage, hypoxic ischemic insult, metabolic disorder or infection.
- •Has been followed clinically on the CRS-R for a minimum two weeks and has undergone a minimum of 4 assessments with the CRS-R.
- •Serial CRS-R scores show at least one subscale on which there is no behavioral sign of conscious awareness (ie, command following, visual fixation or pursuit, object localization or recognition, localization to noxious stimulation, object manipulation, automatic motor responses, functional object use, discernable speech, discernable yes no communication, based on clinically obtained scores contained in the medical record).
- •CRS-R screening examination completed by research staff confirms the absence of a behavioral sign of consciousness on a least one CRS-R subscale.
- •Medically stable (i.e., no systemic illness or disease) and capable of independent ventilation
排除标准
- •History of developmental, neurologic, or major psychiatric disorder resulting in functional disability up to time of enrollment.
- •Evidence or surrogate report of uncontrolled seizure disorder
- •Metallic brain implant or implanted electronic brain medical devices or pacemaker
- •Subjects with craniectomy
- •History of cranioplasty in the frontal region or recent cranioplasty that has not yet fully healed
- •Pregnancy
研究组 & 干预措施
Active tPCS / Sham tDCS
All subject will receive active tPCS and sham tDCS for 20 minutes simultaneously.
干预措施: Active tPCS (Device)
Active tPCS / Sham tDCS
All subject will receive active tPCS and sham tDCS for 20 minutes simultaneously.
干预措施: Sham tDCS (Device)
Sham tPCS / Active tDCS
All subject will receive sham tPCS and active tDCS for 20 minutes simultaneously.
干预措施: Active tDCS (Device)
Sham tPCS / Active tDCS
All subject will receive sham tPCS and active tDCS for 20 minutes simultaneously.
干预措施: Sham tPCS (Device)
Sham tPCS / Sham tDCS
All subject will receive sham tPCS and sham tDCS for 20 minutes simultaneously.
干预措施: Sham tPCS (Device)
Sham tPCS / Sham tDCS
All subject will receive sham tPCS and sham tDCS for 20 minutes simultaneously.
干预措施: Sham tDCS (Device)
结局指标
主要结局
Signal coherence and EEG power as measured by Quantitative electroencephalographic analysis (qEEG)
时间窗: It will be measured over the course of about 3 weeks
EEG measures cortical electrical activity and examines the dynamic changes.
次要结局
- Coma Recovery Scale Revised (CRS-R)(It will be measured over the course of about 3 weeks)
研究者
Aurore Thibaut
Investigator
University of Liege