NCT03811626

Efficacy of Multidimensional Management of Mild Traumatic Brain Injury

Efficacy of Multidimensional Management of Mild Traumatic Brain Injury : A Randomised Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Institut de Recherche sur la Moelle épinière et l'Encéphale · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Traumatic Brain Injury

Interventions

Type	Name	Description
PROCEDURE	cognitive-behavioral rehabilitation	Combination of clinical examination and neuropsychological and psychological tests

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-06-30
• Completion: 2013-06-30
• First posted: 2019-01-22
• Last updated: 2019-01-24

Locations

6 sites across 1 country: France