Luminothérapie Chez Les Patients présentant un état de la Conscience altérée: évaluations Comportementale, de Neuroimagerie et (Neuro)Physiologique.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Changes in the Coma Recovery Scale-Revised scores.
研究概览
简要总结
In this randomized, double-blind, placebo controlled project, the investigators would like to assess the effect of a specific light, as compared to placebo light, on wakefulness (circadian rhythms, homeostasy, sleep-wake cycle), awareness (perceptual and self consciousness), cognition (attention, memory) and underlying brain activity (electrophysiology and neuroimaging)
详细描述
The investigators will use behavioral (CRS-R, CAP, actimeter, brainstem reflexes), physiological (body core temperature, saliva, urine, heart rate, blood sample), neuroimaging and neurophysiological tools (PET, fMRI, TMS-EEG, resting-state and auditory paradigm EEG) before, during and after treatment.
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
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •disorder of consciousness
- •6 weeks post-injury
排除标准
- •dysautonomia
- •acute illnesses (infections with fever)
- •medication that is known to affect circadian rhythmicity (melatonin)
- •uncorrected sensorial deficits or documented history of significant neurological, neurosurgical, developpemental or psychiatric disorders
- •previously known cerebral lesions prior to the brain's insult that lead to disorder of consciousness
- •any contraindication to MRI, EEG, TMS-EEG, or PET (e.g., electronic implanted devices, active epilepsy, external ventricular drain)
- •not medically stable
研究组 & 干预措施
Real light exposition by the mean of Luminette®
All patients will be exposed to a real light (1500 lux, 470 nm) during the treatment phase, 3 times per day (morning, afternoon and evening) for 60 minutes each via goggles providing light at the eyes level. Meanwhile, different assessments will be performed in order evaluating the potential effects of provided light in comparison to placebo ligh. Patients will be given behavioral assessments (Coma Recovery Scale-Revised, Nociception Coma Scale-Revised, brainstem reflexes,...), physiological (body core temperature, saliva, urine, heart rate, blood sample), neuroimaging and neurophysiological tools (PET, fMRI, TMS-EEG, resting-state and auditory paradigm EEG) before, during and after treatment.
干预措施: Light therapy - active (Device)
Placebo light exposition by the mean of Luminette®
All patients will also be exposed to a placebo light (80 lux, 470 nm) during the treatment phase, 3 times per day (morning, afternoon and evening) for 60 minutes each via goggles providing light at the eyes level. Meanwhile, different assessments will be performed in order evaluating the potential effects of provided light in comparison to placebo light. Patients will be given behavioral assessments (Coma Recovery Scale-Revised, Nociception Coma Scale-Revised, brainstem reflexes,...), physiological (body core temperature, saliva, urine, heart rate, blood sample), neuroimaging and neurophysiological tools (PET, fMRI, TMS-EEG, resting-state and auditory paradigm EEG) before, during and after treatment.
干预措施: Placebo light (Device)
结局指标
主要结局
Changes in the Coma Recovery Scale-Revised scores.
时间窗: 4 weeks study
Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with behavioral analyses and diagnosis through the CRS-R results.
次要结局
- Change in sleep-wake cycles through the actimetry, after the exposition of real light instead of placebo light.(4 weeks study)
- Change in sleep-wake cycles through the hemodynamic function of the brain with functional Magnetic Resonance Imaging, after the exposition of real light instead of placebo light.(4 weeks study)
- Change in sleep-wake cycles through the electrical activity of the brain with electroencephalography, after the exposition of real light instead of placebo light.(4 weeks study)
- Change in sleep-wake cycles through analyses of melatonine hormone, after the exposition of real light instead of placebo light.(4 weeks study)
- Change in sleep-wake cycles through temperature measurements, after the exposition of real light instead of placebo light.(4 weeks study)
- Change in sleep-wake cycles through the brain metabolism with Positron Emission Tomography, after the exposition of real light instead of placebo light.(4 weeks study)
- Change in the outcomes by the assessment of the Glasgow Outcome Scale Extended, after the study.(2 years after)
- Change in sleep-wake cycles through the Nociception Coma Scale-Revised, after the exposition of real light instead of placebo light.(4 weeks study)