Diffuse Brain Injury
Conditions
Keywords
brain injury, blue enriched withe bright light therapy, sequel fatigue
Brief 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. 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.
Interventions
OTHERplacebo
THIS GROUP WILL RECEIVE NO BRIGHT LIGHT
DEVICELuminette,Lucimed Belgium
THIS GROUP WILL RECEIVE BLEU LIGHT ENRICHIDED IN WITHE BRIGHT LIGHT
Sponsors
Fondation Garches
Centre d'Investigation Clinique et Technologique 805
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Severity Scale | 30 minutes | Fatigue measure by fatigue severity scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epworth slumber scale | 30 minutes | Subjective Slumber measured by Epworth slumber scale |
| Analog visual scales | 10 minutes | subjective slumber measured by Epworth slumber scale |
| Psychomotor Vigilance Task | 15 minutes | vigilance measured by Psychomotor Vigilance Task |
| P300 | 30 minutes | Cognitive evoked potential measure by P300 |
Countries
France
Outcome results
None listed