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

Primary Purpose

Diffuse Brain Injury

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

placebo

"Luminette",Lucimed Belgium

About this trial

This is an interventional treatment trial for Diffuse Brain Injury focused on measuring brain injury, blue enriched withe bright light therapy, sequel fatigue

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hopital Raymond Poincare

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Severe brain injury patient

Severe brain injury patient with device

Arm Description

Severe brain injury patients with placebo

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

Outcomes

Primary Outcome Measures

Fatigue Severity Scale

Fatigue measure by fatigue severity scale

Secondary Outcome Measures

Epworth slumber scale

Subjective Slumber measured by Epworth slumber scale

Analog visual scales

subjective slumber measured by Epworth slumber scale

Psychomotor Vigilance Task

vigilance measured by Psychomotor Vigilance Task

P300

Cognitive evoked potential measure by P300

Full Information

NCT ID

NCT02420275

First Posted

April 10, 2015

Last Updated

December 13, 2017

Sponsor

Centre d'Investigation Clinique et Technologique 805

Collaborators

Fondation Garches

1. Study Identification

Unique Protocol Identification Number

NCT02420275

Brief Title

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

Acronym

phototrauma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

May 11, 2015 (Actual)

Primary Completion Date

December 1, 2017 (Actual)

Study Completion Date

December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre d'Investigation Clinique et Technologique 805

Collaborators

Fondation Garches

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Brain Injury

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Severe brain injury patient

Arm Type

Placebo Comparator

Arm Description

Severe brain injury patients with placebo

Arm Title

Severe brain injury patient with device

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

THIS GROUP WILL RECEIVE NO BRIGHT LIGHT

Intervention Type

Device

Intervention Name(s)

"Luminette",Lucimed Belgium

Intervention Description

THIS GROUP WILL RECEIVE BLEU LIGHT ENRICHIDED IN WITHE BRIGHT LIGHT

Primary Outcome Measure Information:

Title

Fatigue Severity Scale

Description

Fatigue measure by fatigue severity scale

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

Epworth slumber scale

Description

Subjective Slumber measured by Epworth slumber scale

Time Frame

30 minutes

Title

Analog visual scales

Description

subjective slumber measured by Epworth slumber scale

Time Frame

10 minutes

Title

Psychomotor Vigilance Task

Description

vigilance measured by Psychomotor Vigilance Task

Time Frame

15 minutes

Title

P300

Description

Cognitive evoked potential measure by P300

Time Frame

30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MARIA ANTONIA QUERA SALVA, MD PhD

Organizational Affiliation

RAYMOND POINCARE HOSPITAL

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

SARAH HARTLEY, MD

Organizational Affiliation

RAYMOND POINCARE HOSPITAL

Official's Role

Study Chair

Facility Information:

Facility Name

Hopital Raymond Poincare

City

Garches

ZIP/Postal Code

92380

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

31246878

Citation

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.

Results Reference

derived

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

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