Disorder of ConsciousnessNCT03174119
Light Therapy in Disorders of Consciousness: Behavioral, Neuroimaging and (Neuro)Physiological Assessments.
A study testing Light therapy - active in people with Disorder of Consciousness, run by University of Liege.
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… Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Disorder of Consciousness
- What is being tested?
- Light therapy - active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2019to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- disorder of consciousness
- 6 weeks post-injury
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Olivia Gosseries, 1 contact
About this study
Official title: 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)
Read the 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.
- Conditions
- Disorder of Consciousness
- Being tested
- Light therapy - active, Placebo light
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light therapy - activeDevice
Also called Real light stimulation
Active light will be used for one week, as compared to placebo light.
Placebo lightDevice
Placebo light will be used for one week, as compared to real light exposition.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Placebo light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Identify the improvement in sleep-wake cycle and circadian rhythm after the real light therapy exposure, with behavioral analyses through the NCS-R results.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study startFeb 2019 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivia Gosseries, University of Liege
- Investigators
- Steven Laureys, 1, Study director, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174119
- Sponsor's protocol ID
- OGosseries
- Status last verified
- Oct 2018
- First submitted
- 16 May 2017
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Luminothérapie Chez Les Patients présentant un état de la Conscience altérée: évaluations Comportementale, de Neuroimagerie et (Neuro)Physiologique.
- ClinicalTrials.gov ID
- NCT03174119
- Acronym / sponsor ID
- OGosseries
- Conditions
- Disorder of Consciousness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Feb 2019 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real light exposition by the mean of Luminette® | Active comparator | Device: Light therapy - activeAll 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. |
| Placebo light exposition by the mean of Luminette® | Placebo comparator | Device: Placebo lightAll 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. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- disorder of consciousness
- 6 weeks post-injury
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light therapy - activeAlso: Real light stimulationActive light will be used for one week, as compared to placebo light. | Device | Real light exposition by the mean of Luminette® |
| Placebo lightPlacebo light will be used for one week, as compared to real light exposition. | Device | Placebo light exposition by the mean of Luminette® |
Primary outcome
Changes in the Coma Recovery Scale-Revised scores.
Time frame: 4 weeks study
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.
8 secondary outcomes
Change in sleep-wake cycles through the Nociception Coma Scale-Revised, after the exposition of real light instead of placebo light.
Time frame: 4 weeks study
Change in sleep-wake cycles through the actimetry, after the exposition of real light instead of placebo light.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks study
Change in sleep-wake cycles through analyses of melatonine hormone, after the exposition of real light instead of placebo light.
Time frame: 4 weeks study
Change in sleep-wake cycles through temperature measurements, after the exposition of real light instead of placebo light.
Time frame: 4 weeks study
Change in the outcomes by the assessment of the Glasgow Outcome Scale Extended, after the study.
Time frame: 2 years after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivia Gosseries, 1 contact
Steven Laureys, 1 study director
University of Liege
Questions about this trial
What is this clinical trial studying?
A study testing Light therapy - active in people with Disorder of Consciousness, run by University of Liege.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Séverine Blandiaux, 1 (+3243663915, severine.blandiaux@ulg.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Coma Recovery Scale-Revised scores. (time frame: 4 weeks study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.