Clinical trial NCT03811626: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mild Traumatic Brain Injury
Keywords: Mild TBI
quality of life
coping strategies
symptoms
neuropsychological tests
pain
memory reactive
Cognitive dimension
Lead sponsor: Institut de Recherche sur la Moelle épinière et l'Encéphale
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change in quality of life
timeFrame: Baseline, 6 months -
Secondary outcomes:
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Chu Bicetre
city: Montpellier
country: France
facility: Chu Montpellier
city: Paris
country: France
facility: Chu Bichat/Beaujon
city: Paris
country: France
facility: CHU St ANTOINE
city: Paris
country: France
facility: Chu Tenon
city: Rouen
country: France
facility: Chu Rouen
Study officials:
References:
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.