Light Therapy in Disorders of Consciousness: Behavioral, Neuroimaging and (Neuro)Physiological Assessments.

University of Liege

Status: Unknown

Conditions: Disorder of Consciousness

Treatments: Device: Light therapy - active; Device: Placebo light

Study type: Interventional

Funder types: Other

Identifiers

NCT03174119

OGosseries

Details and patient eligibility

About

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)

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Real light exposition by the mean of Luminette®

Active Comparator group

Description:

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.

Treatment:

Device: Light therapy - active

Placebo light exposition by the mean of Luminette®

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo light