Efficacy of Multidimensional Management of Mild Traumatic Brain Injury

Institut de Recherche sur la Moelle épinière et l'Encéphale

Status

Completed

Conditions

Mild Traumatic Brain Injury

Treatments

Procedure: cognitive-behavioral rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT03811626

2012-A00015-38

Details and patient eligibility

About

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.

Enrollment

221 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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