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Efficacy of Multidimensional Management of Mild Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03811626
Recruitment Status : Completed
First Posted : January 22, 2019
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Institut de Recherche sur la Moelle épinière et l'Encéphale

Brief Summary:
Unfavorable outcomes (UO) are seen in 15 to 20% of patients with mild traumatic brain injury (mTBI). Early identification of patients at risk for UO is crucial for suitable management to be initiated, increasing their chances for a return to a normal life. The investigators previously developed a diagnostic tool enabling early identification (8 to 21 days after the injury) of patients likely to develop UO. In the present study, the investigators examined the value and beneficial effects of early multidimensional management (MM) on prognosis. The investigators used a diagnostic tool to classify 221 mTBI patients as UO (97) or FO (favorable outcome) (124). Patients whose initial risk factors point to UO are at risk of developing post-concussion syndrome (PCS). UO patients were randomized into 2 groups: a group that underwent MM (cognitive-behavioral rehabilitation) (34) and a group with no specific management (46). At 6 months, these 2 groups were compared and the impact of MM on outcome was assessed. Among patients initially classified as FO (101), 95% had FO at 6 months and only 5 had PCS as defined by DSM-IV classification. Of the UO patients who received MM, 94% had no PCS 6 months after injury, whereas 52% of the UO patients who did not receive MM had persistent PCS. The effect of MM on the recovery of patients at 6 months, once adjusted for the main confounding factors, was statistically significant (p<0.001). These results show that the initiation of MM after early identification of at-risk mTBI patients can considerably improves their prognosis.

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Procedure: cognitive-behavioral rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Efficacy of Multidimensional Management of Mild Traumatic Brain Injury : A Randomised Clinical Trial
Actual Study Start Date : April 1, 2012
Actual Primary Completion Date : June 30, 2013
Actual Study Completion Date : June 30, 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Patient who underwent cognitive-behavioral rehabilitation
Procedure: cognitive-behavioral rehabilitation
Combination of clinical examination and neuropsychological and psychological tests

No Intervention: Comparator
Patient with no specific management



Primary Outcome Measures :
  1. Change in quality of life [ Time Frame: Baseline, 6 months - ]
    Change in quality of life assessed by QOLIBRI (Quality of Life after Brain Injury) Scale - QOLIBRI scale assess health-related quality of life (HRQoL) of individuals after traumatic brain injury. QOLIBRI is a comprehensive questionnaire with 37 items covering six dimensions of HRQoL after TBI. The QOLIBRI scores are reported on a 0-100 scale , where 0=worst possible quality of life and 100=best possible quality of life.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Patients aged 18 to 65 who have suffered mTBI, have health care coverage, who understand French, who can be followed for 6 months, and who are able to understand, reply, and cooperate.

Exclusion Criteria:

  • Patient intubated and/or ventilated and/or sedated upon arrival at hospital
  • Patient with injury to the medulla and with neurological signs or multiple injuries (at least 1 of which is life-threatening)
  • Brain injury incurred during a suicide attempt
  • Patient presenting psychiatric or psychological disorders that are debilitating and/or interfere with follow-up and/or evaluation
  • Psychoactive treatment ongoing at the time of injury
  • History of hospitalization in specialized a psychiatric setting and/or sick leave for psychological reasons
  • Patient with a neurological disorder
  • Patient with substance dependence
  • Subject under guardianship or wardship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811626


Locations
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France
Chu Bicetre
Le Kremlin-Bicêtre, France
Chu Montpellier
Montpellier, France
Chu Bichat/Beaujon
Paris, France
CHU St ANTOINE
Paris, France
Chu Tenon
Paris, France
Chu Rouen
Rouen, France
Sponsors and Collaborators
Institut de Recherche sur la Moelle épinière et l'Encéphale
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut de Recherche sur la Moelle épinière et l'Encéphale
ClinicalTrials.gov Identifier: NCT03811626    
Other Study ID Numbers: 2012-A00015-38
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut de Recherche sur la Moelle épinière et l'Encéphale:
Mild TBI
quality of life
coping strategies
symptoms
neuropsychological tests
pain
memory reactive
Cognitive dimension
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating