Diffuse Brain InjuryphototraumaNCT02420275
Trial Estimating the Efficiency of the Light Therapy in Brain Trauma Sequel Fatigue
A study testing "Luminette",Lucimed Belgium in people with Diffuse Brain Injury, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
After a brain injury (BI) , patients complain in particular about sequel fatigue. This symptom affects about 50 % of the patients; it is severe, with a repercussion on quality of life, reeducation and occupational reintegration, and persists often at a distance of the accident. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diffuse Brain Injury
- What is being tested?
- "Luminette",Lucimed Belgium
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2015to 1 Dec 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe brain injury patients more than 6 months after the trauma
- Out of the phase of post-traumatic amnesia (score in Galveston Orientation and Amnesia Test (GOAT) upper to 75)
- Initial score on the Glasgow coma scale inferior or equal to 8 within the first 24 hours after brain injury, except sedation
- Age from 18 to 65 years old
- Fatigue severity score ( FSS) superior or equal to 4 and/or a score on the sleepiness Epworth scale superior or equal to 10 and/or a score to the quality questionnaire of sleep of Pittsburg > in 5
- Having given a writing informed consent
- Registered on the Social Security
Who cannot join
- Non-stabilized psychiatric neurological affection and/or endocrine diseases or drug addiction
- Major depression diagnosed with the "MINI" depression scale
- Cognitive, behavioural or motor disorders incompatible with use of phototherapy glasses
- Night workers or transméridien journey in the last month
- Chronic fatigue syndrome before the accident
- Deafness
Show all 12Show fewer
- Major obesity (BMI > 33)
- High risk of apnea syndrome in the Berlin questionnaire
- Consumption of long half-l hypnotics or stimulants
- Treatments with antidepressants are tolerated if the dose is stable during all the participation on approval and for at least one month before the inclusion.
- Eye lesion, in particular of the retina
- Photosensibility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled Randomized Trial Estimating the Efficiency of Blue Enriched White Light on Sequel Fatigue, in Victims of Severe Cranial Traumas
After a brain injury (BI) , patients complain in particular about sequel fatigue. This symptom affects about 50 % of the patients; it is severe, with a repercussion on quality of life, reeducation and occupational reintegration, and persists often at a distance of the accident. The investigators' hypothesis is that patients who presented a severe BI could benefit from a treatment by withe blue enriched bright light in order to improve fatigue and quality of life.
Read the detailed description
After a BI , patients complain in particular about sequel fatigue. This symptom affects about 50 % of the patients; it is severe, with a repercussion on quality of life, reeducation and occupational reintegration, and persists often at a distance of the accident. The investigators' hypothesis is that patients who presented a severe BI could benefit from a treatment by blue enriched withe bright light in order to improve fatigue and quality of life.
The main objective is to decrease fatigue and the secondary objectives are to improve quality of life,decrease daytime sleepiness and increase vigilance.
This is a randomized clinical trial with 2 groups blue enriched withe bright light versus nothing) including 20 patients.The treatment will take 8 weeks with 30 minutes exposition at awakening to withe blue enriched bright light (Luminette, Belgium). The investigators willl estimate the fatigue severity scale score , the quality of life the score (SF12), the sleepiness Epworth score, and the Psychomotor Vigilance Task (PVT) The investigators will included patient with severe BI more than six months after the BI.
- Conditions
- Diffuse Brain Injury
- Being tested
- placebo, "Luminette",Lucimed Belgium
- Keywords
- brain injury, blue enriched withe bright light therapy, sequel fatigue
- Medical subject headings
- Brain Injuries, Diffuse, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
THIS GROUP WILL RECEIVE NO BRIGHT LIGHT
"Luminette",Lucimed BelgiumDevice
THIS GROUP WILL RECEIVE BLEU LIGHT ENRICHIDED IN WITHE BRIGHT LIGHT
| Study group | Role | What they receive |
|---|---|---|
| Severe brain injury patient | Placebo comparator | Severe brain injury patients with placebo Receives: Other: placebo |
| Severe brain injury patient with device | Experimental | Severe brain injury patients withe with "Luminette",Lucimed Belgium Receives: Device: "Luminette",Lucimed Belgium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale
Fatigue measure by fatigue severity scale
Measured: 30 minutes
Secondary outcomes (4)
Epworth slumber scale
Subjective Slumber measured by Epworth slumber scale
Measured: 30 minutes
Analog visual scales
subjective slumber measured by Epworth slumber scale
Measured: 10 minutes
Psychomotor Vigilance Task
vigilance measured by Psychomotor Vigilance Task
Measured: 15 minutes
P300
Cognitive evoked potential measure by P300
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study start11 May 2015
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diffuse Brain InjuryStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Garches
- Responsible party
- Sponsor
- Investigators
- MARIA ANTONIA QUERA SALVA, MD PhD, Principal investigator, RAYMOND POINCARE HOSPITALSARAH HARTLEY, MD, Study chair, RAYMOND POINCARE HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420275
- Sponsor's protocol ID
- 2015-A000321-48
- Acronym
- phototrauma
- Status last verified
- Feb 2017
- First submitted
- 10 Apr 2015
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Quera Salva MA, Azabou E, Hartley S, Sauvagnac R, Leotard A, Vaugier I, Pradat Diehl P, Vallat-Azouvi C, Barbot F, Azouvi P. Blue-Enriched White Light Therapy Reduces Fatigue in Survivors of Severe Traumatic Brain Injury: A Randomized Controlled Trial. J Head Trauma Rehabil. 2020 Mar/Apr;35(2):E78-E85. doi: 10.1097/HTR.0000000000000500.
PubMed 31246878
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Randomized Trial Estimating the Efficiency of Blue Enriched White Light on Sequel Fatigue, in Victims of Severe Cranial Traumas
- ClinicalTrials.gov ID
- NCT02420275
- Acronym / sponsor ID
- phototrauma / 2015-A000321-48
- Conditions
- Diffuse Brain Injury
- Keywords
- brain injury, blue enriched withe bright light therapy, sequel fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- Fondation Garches
- Study start
- 11 May 2015 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 17 Apr 2015 (estimated)
- 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.
After a brain injury (BI) , patients complain in particular about sequel fatigue. This symptom affects about 50 % of the patients; it is severe, with a repercussion on quality of life, reeducation and occupational reintegration, and persists often at a distance of the accident. The investigators' hypothesis is that patients who presented a severe BI could benefit from a treatment by withe blue enriched bright light in order to improve fatigue and quality of life.
Detailed description
After a BI , patients complain in particular about sequel fatigue. This symptom affects about 50 % of the patients; it is severe, with a repercussion on quality of life, reeducation and occupational reintegration, and persists often at a distance of the accident. The investigators' hypothesis is that patients who presented a severe BI could benefit from a treatment by blue enriched withe bright light in order to improve fatigue and quality of life.
The main objective is to decrease fatigue and the secondary objectives are to improve quality of life,decrease daytime sleepiness and increase vigilance.
This is a randomized clinical trial with 2 groups blue enriched withe bright light versus nothing) including 20 patients.The treatment will take 8 weeks with 30 minutes exposition at awakening to withe blue enriched bright light (Luminette, Belgium). The investigators willl estimate the fatigue severity scale score , the quality of life the score (SF12), the sleepiness Epworth score, and the Psychomotor Vigilance Task (PVT) The investigators will included patient with severe BI more than six months after the BI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe brain injury patient | Placebo comparator | Other: placeboSevere brain injury patients with placebo |
| Severe brain injury patient with device | Experimental | Device: "Luminette",Lucimed BelgiumSevere brain injury patients withe with "Luminette",Lucimed Belgium |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Severe brain injury patients more than 6 months after the trauma
- Out of the phase of post-traumatic amnesia (score in Galveston Orientation and Amnesia Test (GOAT) upper to 75)
- Initial score on the Glasgow coma scale inferior or equal to 8 within the first 24 hours after brain injury, except sedation
- Age from 18 to 65 years old
- Fatigue severity score ( FSS) superior or equal to 4 and/or a score on the sleepiness Epworth scale superior or equal to 10 and/or a score to the quality questionnaire of sleep of Pittsburg > in 5
Key exclusion criteria (12 listed)
- Non-stabilized psychiatric neurological affection and/or endocrine diseases or drug addiction
- Major depression diagnosed with the "MINI" depression scale
- Cognitive, behavioural or motor disorders incompatible with use of phototherapy glasses
- Night workers or transméridien journey in the last month
- Chronic fatigue syndrome before the accident
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 |
|---|---|---|
| placeboTHIS GROUP WILL RECEIVE NO BRIGHT LIGHT | Other | Severe brain injury patient |
| "Luminette",Lucimed BelgiumTHIS GROUP WILL RECEIVE BLEU LIGHT ENRICHIDED IN WITHE BRIGHT LIGHT | Device | Severe brain injury patient with device |
Primary outcome
Fatigue Severity Scale
Time frame: 30 minutes
Fatigue measure by fatigue severity scale
4 secondary outcomes
Epworth slumber scale
Time frame: 30 minutes
Analog visual scales
Time frame: 10 minutes
Psychomotor Vigilance Task
Time frame: 15 minutes
P300
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
- Derived from this study: PubMed 31246878Quera Salva MA, Azabou E, Hartley S, Sauvagnac R, Leotard A, Vaugier I, Pradat Diehl P, Vallat-Azouvi C, Barbot F, Azouvi P. Blue-Enriched White Light Therapy Reduces Fatigue in Survivors of Severe Traumatic Brain Injury: A Randomized Controlled Trial. J Head Trauma Rehabil. 2020 Mar/Apr;35(2):E78-E85. doi: 10.1097/HTR.0000000000000500.
Related trials for Diffuse Brain Injury
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Screening Emotions in Adolescents at the Hospital for mTBI
Brain Injury Traumatic Mild, Brain Injuries
RecruitingPhase 2
Assessment of Noninvasive Neuromodulation in a Group of Traumatic Brain Injured Patients and Healthy Volunteers
Traumatic Brain Injury
Recruiting
NEUROBALANCE Training to Improve Postural Control in Individuals With Traumatic Brain Injury
Traumatic Brain Injury, TBI
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.
MARIA ANTONIA QUERA SALVA, MD PhD principal investigator
RAYMOND POINCARE HOSPITAL
SARAH HARTLEY, MD study chair
RAYMOND POINCARE HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Luminette",Lucimed Belgium in people with Diffuse Brain Injury, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
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 7 inclusion and 12 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: finished, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02420275, which also lists 1 linked publication.
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 15 Dec 2017.