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Efficacy of Multidimensional Management of Mild Traumatic Brain Injury

Primary Purpose

Mild Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cognitive-behavioral rehabilitation
Sponsored by
Institut de Recherche sur la Moelle épinière et l'Encéphale
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mild Traumatic Brain Injury focused on measuring Mild TBI, quality of life, coping strategies, symptoms, neuropsychological tests, pain, memory reactive, Cognitive dimension

Eligibility Criteria

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

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

Sites / Locations

  • Chu Bicetre
  • Chu Montpellier
  • Chu Bichat/Beaujon
  • CHU St ANTOINE
  • Chu Tenon
  • Chu Rouen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Comparator

Arm Description

Patient who underwent cognitive-behavioral rehabilitation

Patient with no specific management

Outcomes

Primary Outcome Measures

Change in quality of life
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.

Secondary Outcome Measures

Full Information

First Posted
January 18, 2019
Last Updated
January 23, 2019
Sponsor
Institut de Recherche sur la Moelle épinière et l'Encéphale
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1. Study Identification

Unique Protocol Identification Number
NCT03811626
Brief Title
Efficacy of Multidimensional Management of Mild Traumatic Brain Injury
Official Title
Efficacy of Multidimensional Management of Mild Traumatic Brain Injury : A Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2012 (Actual)
Primary Completion Date
June 30, 2013 (Actual)
Study Completion Date
June 30, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherche sur la Moelle épinière et l'Encéphale

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury
Keywords
Mild TBI, quality of life, coping strategies, symptoms, neuropsychological tests, pain, memory reactive, Cognitive dimension

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patient who underwent cognitive-behavioral rehabilitation
Arm Title
Comparator
Arm Type
No Intervention
Arm Description
Patient with no specific management
Intervention Type
Procedure
Intervention Name(s)
cognitive-behavioral rehabilitation
Intervention Description
Combination of clinical examination and neuropsychological and psychological tests
Primary Outcome Measure Information:
Title
Change in quality of life
Description
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.
Time Frame
Baseline, 6 months -

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Chu Bicetre
City
Le Kremlin-Bicêtre
Country
France
Facility Name
Chu Montpellier
City
Montpellier
Country
France
Facility Name
Chu Bichat/Beaujon
City
Paris
Country
France
Facility Name
CHU St ANTOINE
City
Paris
Country
France
Facility Name
Chu Tenon
City
Paris
Country
France
Facility Name
Chu Rouen
City
Rouen
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31551902
Citation
Caplain S, Chenuc G, Blancho S, Marque S, Aghakhani N. Efficacy of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury for Preventing Post-concussional Syndrome in Individuals With High Risk of Poor Prognosis: A Randomized Clinical Trial. Front Neurol. 2019 Sep 4;10:929. doi: 10.3389/fneur.2019.00929. eCollection 2019.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/29312112
Description
Early Detection of Poor Outcome after Mild Traumatic Brain Injury: Predictive Factors Using a Multidimensional Approach a Pilot Study.

Learn more about this trial

Efficacy of Multidimensional Management of Mild Traumatic Brain Injury

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