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

Not Applicable

Completed

• Conditions: Diffuse Brain Injury
• Interventions: Device: "Luminette",Lucimed Belgium; Other: placebo

• Registration Number: NCT02420275
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

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.

Study Timeline

• Study First Submitted: 2015-04-10
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-17
• Study Start: 2015-05-11
• Status Verified: 2017-02
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Last Update Submitted: 2017-12-13
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Severe brain injury patient with device	"Luminette",Lucimed Belgium	Severe brain injury patients withe with "Luminette",Lucimed Belgium
Severe brain injury patient	placebo	Severe brain injury patients with placebo

Primary Outcome Measures

Name	Time	Method
Fatigue Severity Scale	30 minutes	Fatigue measure by fatigue severity scale

Secondary Outcome Measures

Name	Time	Method
Analog visual scales	10 minutes	subjective slumber measured by Epworth slumber scale
Epworth slumber scale	30 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

Trial Locations

Locations (1)

Hopital Raymond Poincare; 🇫🇷 Garches, France