Clinical trial NCT03174119: Light Therapy in Disorders of Consciousness: Behavioral, Neuroimaging and (Neuro)Physiological Assessments.
Official title: Luminothérapie Chez Les Patients présentant un état de la Conscience altérée: évaluations Comportementale, de Neuroimagerie et (Neuro)Physiologique.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Disorder of Consciousness
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in the Coma Recovery Scale-Revised scores.
timeFrame: 4 weeks study
Secondary outcomes:
measure: Change in sleep-wake cycles through the Nociception Coma Scale-Revised, after the exposition of real light instead of placebo light.
timeFrame: 4 weeks study
measure: Change in sleep-wake cycles through the actimetry, after the exposition of real light instead of placebo light.
timeFrame: 4 weeks study
measure: Change in sleep-wake cycles through the brain metabolism with Positron Emission Tomography, after the exposition of real light instead of placebo light.
timeFrame: 4 weeks study
measure: 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.
timeFrame: 4 weeks study
measure: Change in sleep-wake cycles through the electrical activity of the brain with electroencephalography, after the exposition of real light instead of placebo light.
timeFrame: 4 weeks study
measure: Change in sleep-wake cycles through analyses of melatonine hormone, after the exposition of real light instead of placebo light.
timeFrame: 4 weeks study
measure: Change in sleep-wake cycles through temperature measurements, after the exposition of real light instead of placebo light.
timeFrame: 4 weeks study
measure: Change in the outcomes by the assessment of the Glasgow Outcome Scale Extended, after the study.
timeFrame: 2 years after
Other outcomes:
Locations:
Study officials:
affiliation: University of Liege
name: Steven Laureys, 1
role: STUDY_DIRECTOR
References: