Light Therapy in Disorders of Consciousness: Behavioral, Neuroimaging and (Neuro)Physiological Assessments.
NCT ID: NCT03174119
Last Updated: 2018-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2019-02-28
2021-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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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.
Light therapy - active
Active light will be used for one week, as compared to placebo light.
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.
Placebo light
Placebo light will be used for one week, as compared to real light exposition.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 6 weeks post-injury
Exclusion Criteria
* 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
16 Years
80 Years
ALL
No
Sponsors
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University of Liege
OTHER
Responsible Party
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Olivia Gosseries
Dr
Principal Investigators
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Steven Laureys, 1
Role: STUDY_DIRECTOR
University of Liege
Central Contacts
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Other Identifiers
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OGosseries
Identifier Type: -
Identifier Source: org_study_id
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