Light Therapy in Disorders of Consciousness: Behavioral, Neuroimaging and (Neuro)Physiological Assessments.
- Conditions
- Disorder of Consciousness
- Interventions
- Device: Placebo lightDevice: Light therapy - active
- Registration Number
- NCT03174119
- Lead Sponsor
- University of Liege
- Brief Summary
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)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- disorder of consciousness
- 6 weeks post-injury
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo light exposition by the mean of Luminette® Placebo light 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. Real light exposition by the mean of Luminette® Light therapy - active 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.
- Primary Outcome Measures
Name Time Method Changes in the Coma Recovery Scale-Revised scores. 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.
- Secondary Outcome Measures
Name Time Method Change in sleep-wake cycles through the actimetry, after the exposition of real light instead of placebo light. 4 weeks study Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with behavioral analyses through the arms movements measured with the actimetry.
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 Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with fMRI analyses.
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 Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with EEG analyses.
Change in sleep-wake cycles through analyses of melatonine hormone, after the exposition of real light instead of placebo light. 4 weeks study Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with urine analyses.
Change in sleep-wake cycles through temperature measurements, after the exposition of real light instead of placebo light. 4 weeks study Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with body core temperature analyses.
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 Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with PET scan analyses.
Change in the outcomes by the assessment of the Glasgow Outcome Scale Extended, after the study. 2 years after Improvement of the recovery's outcomes after the end of the real light therapy exposure.
Change in sleep-wake cycles through the Nociception Coma Scale-Revised, after the exposition of real light instead of placebo light. 4 weeks study Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with behavioral analyses through the NCS-R results.