Disorder of Consciousness
Conditions
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.
Interventions
DEVICELight therapy - active
Active light will be used for one week, as compared to placebo light.
DEVICEPlacebo light
Placebo light will be used for one week, as compared to real light exposition.
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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. |
| 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 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 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. |
Contacts
Primary ContactSéverine Blandiaux, 1
Backup ContactOlivia Gosseries, 1
Outcome results
None listed