Luminothérapie Chez Les Patients présentant un état de la Conscience altérée: évaluations Comportementale, de Neuroimagerie et (Neuro)Physiologique.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Disorder of Consciousness
- Sponsor
- University of Liege
- Enrollment
- 50
- Primary Endpoint
- Changes in the Coma Recovery Scale-Revised scores.
- Last Updated
- 7 years ago
Overview
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.
Investigators
Olivia Gosseries
Dr
University of Liege
Eligibility Criteria
Inclusion Criteria
- •disorder of consciousness
- •6 weeks post-injury
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Changes in the Coma Recovery Scale-Revised scores.
Time Frame: 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 Outcomes
- 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)