Back to resultsLight Therapy in Disorders of Consciousness: Behavioral, Neuroimaging and (Neuro)Physiological Assessments.
Primary Purpose
Disorder of Consciousness
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Light therapy - active
Placebo light
Sponsored by
About this trial
This is an interventional treatment trial for Disorder of Consciousness
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Real light exposition by the mean of Luminette®
Placebo light exposition by the mean of Luminette®
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03174119
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2019 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Consciousness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Real light exposition by the mean of Luminette®
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo light exposition by the mean of Luminette®
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Light therapy - active
Other Intervention Name(s)
Real light stimulation
Intervention Description
Active light will be used for one week, as compared to placebo light.
Intervention Type
Device
Intervention Name(s)
Placebo light
Intervention Description
Placebo light will be used for one week, as compared to real light exposition.
Primary Outcome Measure Information:
Title
Changes in the Coma Recovery Scale-Revised scores.
Description
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.
Time Frame
4 weeks study
Secondary Outcome Measure Information:
Title
Change in sleep-wake cycles through the Nociception Coma Scale-Revised, after the exposition of real light instead of placebo light.
Description
Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with behavioral analyses through the NCS-R results.
Time Frame
4 weeks study
Title
Change in sleep-wake cycles through the actimetry, after the exposition of real light instead of placebo light.
Description
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.
Time Frame
4 weeks study
Title
Change in sleep-wake cycles through the brain metabolism with Positron Emission Tomography, after the exposition of real light instead of placebo light.
Description
Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with PET scan analyses.
Time Frame
4 weeks study
Title
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.
Description
Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with fMRI analyses.
Time Frame
4 weeks study
Title
Change in sleep-wake cycles through the electrical activity of the brain with electroencephalography, after the exposition of real light instead of placebo light.
Description
Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with EEG analyses.
Time Frame
4 weeks study
Title
Change in sleep-wake cycles through analyses of melatonine hormone, after the exposition of real light instead of placebo light.
Description
Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with urine analyses.
Time Frame
4 weeks study
Title
Change in sleep-wake cycles through temperature measurements, after the exposition of real light instead of placebo light.
Description
Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with body core temperature analyses.
Time Frame
4 weeks study
Title
Change in the outcomes by the assessment of the Glasgow Outcome Scale Extended, after the study.
Description
Improvement of the recovery's outcomes after the end of the real light therapy exposure.
Time Frame
2 years after
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Séverine Blandiaux, 1
Phone
+3243663915
Email
severine.blandiaux@ulg.ac.be
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia Gosseries, 1
Email
ogosseries@ulg.ac.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Laureys, 1
Organizational Affiliation
University of Liege
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Light Therapy in Disorders of Consciousness: Behavioral, Neuroimaging and (Neuro)Physiological Assessments.
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