Trial Estimating the Efficiency of the Light Therapy in Brain Trauma Sequel Fatigue

Study Overview
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Brief Summary
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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
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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.

Official Title
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Controlled Randomized Trial Estimating the Efficiency of Blue Enriched White Light on Sequel Fatigue, in Victims of Severe Cranial Traumas

Conditions
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Diffuse Brain Injury

Intervention / Treatment
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* Other: placebo
* Device: Luminette,Lucimed Belgium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Severe brain injury patient<br>Severe brain injury patients with placebo | Other: placebo<br>* THIS GROUP WILL RECEIVE NO BRIGHT LIGHT<br>|
| Experimental: Severe brain injury patient with device<br>Severe brain injury patients withe with Luminette,Lucimed Belgium | Device: Luminette,Lucimed Belgium<br>* THIS GROUP WILL RECEIVE BLEU LIGHT ENRICHIDED IN WITHE BRIGHT LIGHT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Severity Scale | Fatigue measure by fatigue severity scale | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epworth slumber scale | Subjective Slumber measured by Epworth slumber scale | 30 minutes | 
| Analog visual scales | subjective slumber measured by Epworth slumber scale | 10 minutes | 
| Psychomotor Vigilance Task | vigilance measured by Psychomotor Vigilance Task | 15 minutes | 
| P300 | Cognitive evoked potential measure by P300 | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sequel fatigue, brain injury, blue enriched withe bright light therapy