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

NCT ID: NCT02420275

Last Updated: 2017-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-11
• Study Completion Date: 2017-12-01

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.

Conditions

Diffuse Brain Injury

Keywords

brain injury; blue enriched withe bright light therapy; sequel fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Severe brain injury patient

Severe brain injury patients with placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

THIS GROUP WILL RECEIVE NO BRIGHT LIGHT

Severe brain injury patient with device

Severe brain injury patients withe with "Luminette",Lucimed Belgium

Group Type: EXPERIMENTAL

"Luminette",Lucimed Belgium

Intervention Type: DEVICE

THIS GROUP WILL RECEIVE BLEU LIGHT ENRICHIDED IN WITHE BRIGHT LIGHT

Interventions

placebo

THIS GROUP WILL RECEIVE NO BRIGHT LIGHT

Intervention Type: OTHER

"Luminette",Lucimed Belgium

THIS GROUP WILL RECEIVE BLEU LIGHT ENRICHIDED IN WITHE BRIGHT LIGHT

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Garches

OTHER

Sponsor Role: collaborator

Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MARIA ANTONIA QUERA SALVA, MD PhD

Role: PRINCIPAL_INVESTIGATOR

RAYMOND POINCARE HOSPITAL

SARAH HARTLEY, MD

Role: STUDY_CHAIR

RAYMOND POINCARE HOSPITAL

Locations

Hopital Raymond Poincare

Garches, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 31246878 (View on PubMed)

Other Identifiers

2015-A000321-48

Identifier Type: -

Identifier Source: org_study_id