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

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.

Study Overview

• Status: Completed
• Conditions: Diffuse Brain Injury
• Intervention / Treatment: Other: placebo; Device: "Luminette",Lucimed Belgium

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Hôpital Raymond Poincaré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre d'Investigation Clinique et Technologique 805
• Collaborators: Fondation Garches
• Investigators: Principal Investigator: MARIA ANTONIA QUERA SALVA, MD PhD, Raymond Poincaré Hospital; Study Chair: SARAH HARTLEY, MD, Raymond Poincaré Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: April 10, 2015
• First Submitted That Met QC Criteria: April 14, 2015
• First Posted (Estimate): April 17, 2015

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: brain injury; blue enriched withe bright light therapy; sequel fatigue
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Fatigue; Brain Injuries; Brain Injuries, Diffuse
• Other Study ID Numbers: 2015-A000321-48