NCT02420275

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

May 11, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 15, 2017

Status Verified

February 1, 2017

Enrollment Period

2.6 years

First QC Date

April 10, 2015

Last Update Submit

December 13, 2017

Conditions

Diffuse Brain Injury

Keywords

brain injuryblue enriched withe bright light therapysequel fatigue

Outcome Measures

Primary Outcomes (1)

  • Fatigue Severity Scale

    Fatigue measure by fatigue severity scale

    30 minutes

Secondary Outcomes (4)

  • Epworth slumber scale

    30 minutes

  • Analog visual scales

    10 minutes

  • Psychomotor Vigilance Task

    15 minutes

  • P300

    30 minutes

Study Arms (2)

Severe brain injury patient

PLACEBO COMPARATOR

Severe brain injury patients with placebo

Other: placebo

Severe brain injury patient with device

EXPERIMENTAL

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

Device: "Luminette",Lucimed Belgium

Interventions

placeboOTHER

THIS GROUP WILL RECEIVE NO BRIGHT LIGHT

Severe brain injury patient
"Luminette",Lucimed BelgiumDEVICE

THIS GROUP WILL RECEIVE BLEU LIGHT ENRICHIDED IN WITHE BRIGHT LIGHT

Severe brain injury patient with device

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Eye lesion, in particular of the retina
  • Photosensibility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Raymond Poincare

Garches, 92380, France

Location

Related Publications (1)

  • 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.

    PMID: 31246878DERIVED

MeSH Terms

Conditions

Brain Injuries, DiffuseBrain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • MARIA ANTONIA QUERA SALVA, MD PhD

    RAYMOND POINCARE HOSPITAL

    PRINCIPAL INVESTIGATOR

  • SARAH HARTLEY, MD

    RAYMOND POINCARE HOSPITAL

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2015

First Posted

April 17, 2015

Study Start

May 11, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 15, 2017

Record last verified: 2017-02

Locations

FR(1)