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

Luminothérapie Chez Les Patients présentant un état de la Conscience altérée: évaluations Comportementale, de Neuroimagerie et (Neuro)Physiologique.

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)

Study Overview

• Status: Unknown
• Conditions: Disorder of Consciousness
• Intervention / Treatment: Device: Light therapy - active; Device: Placebo light

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Séverine Blandiaux, 1; Phone Number: +3243663915; Email: severine.blandiaux@ulg.ac.be
• Study Contact Backup: Name: Olivia Gosseries, 1; Email: ogosseries@ulg.ac.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 78 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Real light exposition by the mean of Luminette®; 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; Active light will be used for one week, as compared to placebo light.; Other Names: Real light stimulation
Placebo Comparator: Placebo light exposition by the mean of Luminette®; 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; Placebo light will be used for one week, as compared to real light exposition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep-wake cycles through the Nociception Coma Scale-Revised, after the exposition of real light instead of placebo light.	Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with behavioral analyses through the NCS-R results.	4 weeks study
Change in sleep-wake cycles through the actimetry, after the exposition of real light instead of placebo light.	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.	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.	Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with PET scan analyses.	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.	Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with fMRI analyses.	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.	Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with EEG analyses.	4 weeks study
Change in sleep-wake cycles through analyses of melatonine hormone, after the exposition of real light instead of placebo light.	Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with urine analyses.	4 weeks study
Change in sleep-wake cycles through temperature measurements, after the exposition of real light instead of placebo light.	Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with body core temperature analyses.	4 weeks study
Change in the outcomes by the assessment of the Glasgow Outcome Scale Extended, after the study.	Improvement of the recovery's outcomes after the end of the real light therapy exposure.	2 years after

Collaborators and Investigators

• Sponsor: University of Liege
• Investigators: Study Director: Steven Laureys, 1, University of Liège

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 29, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders
• Other Study ID Numbers: OGosseries

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No