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

Disorder of Consciousness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03174119
• Other study ID #: OGosseries
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2019
• Est. completion date: January 2021

Study information

• Verified date: October 2018
• Source: University Hospital of Liege
• Contact: Séverine Blandiaux, 1
• Phone: +3243663915
• Email: severine.blandiaux[@]ulg.ac.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorder of Consciousness

Intervention

Device:
• Light therapy - active
Active light will be used for one week, as compared to placebo light.
• Placebo light
Placebo light will be used for one week, as compared to real light exposition.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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