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

Diffuse Brain Injury Clinical Trial

— phototrauma  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02420275
• Other study ID #: 2015-A000321-48
• Status: Completed
• Phase: N/A
• First received: April 10, 2015
• Last updated: December 13, 2017
• Start date: May 11, 2015
• Est. completion date: December 1, 2017

Study information

• Verified date: February 2017
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Diffuse Brain Injury
• Fatigue

Intervention

Other:
• placebo
THIS GROUP WILL RECEIVE NO BRIGHT LIGHT

Device:
• "Luminette",Lucimed Belgium
THIS GROUP WILL RECEIVE BLEU LIGHT ENRICHIDED IN WITHE BRIGHT LIGHT

Locations

Country	Name	City	State
France	Hopital Raymond Poincare	Garches

Sponsors (2)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805	Fondation Garches

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Severity Scale	Fatigue measure by fatigue severity scale	30 minutes
Secondary	Epworth slumber scale	Subjective Slumber measured by Epworth slumber scale	30 minutes
Secondary	Analog visual scales	subjective slumber measured by Epworth slumber scale	10 minutes
Secondary	Psychomotor Vigilance Task	vigilance measured by Psychomotor Vigilance Task	15 minutes
Secondary	P300	Cognitive evoked potential measure by P300	30 minutes