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

NCT03174119 | Unknown DMC

• 1 other identifier: OGosseries
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Disorder of Consciousness

Outcome Measures

Primary Outcomes (1)

• Changes in the Coma Recovery Scale-Revised scores.

  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.

  4 weeks study

Secondary Outcomes (8)

• Change in sleep-wake cycles through the Nociception Coma Scale-Revised, after the exposition of real light instead of placebo light.

  4 weeks study

• 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 brain metabolism with Positron Emission Tomography, 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

Study Arms (2)

Real light exposition by the mean of Luminette®

ACTIVE COMPARATOR

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.

Device: Light therapy - active

Placebo light exposition by the mean of Luminette®

PLACEBO COMPARATOR

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.

Device: Placebo light

Interventions

Light therapy - active DEVICE

Active light will be used for one week, as compared to placebo light.

Also known as: Real light stimulation

Real light exposition by the mean of Luminette®

Placebo light DEVICE

Placebo light will be used for one week, as compared to real light exposition.

Placebo light exposition by the mean of Luminette®

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• disorder of consciousness
• weeks post-injury

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liege: lead

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Steven Laureys, 1

  University of Liege

  STUDY DIRECTOR

Central Study Contacts

Séverine Blandiaux, 1

CONTACT

+3243663915; severine.blandiaux@ulg.ac.be

Olivia Gosseries, 1

CONTACT

ogosseries@ulg.ac.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: June 2, 2017
• Study Start: February 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: October 23, 2018

Record last verified: 2018-10