MedTrace Logo

Efficacy of Multidimensional Management of Mild Traumatic Brain Injury

NCT03811626 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2019-01-24

No results posted yet for this study

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

PROCEDURE

cognitive-behavioral rehabilitation

Combination of clinical examination and neuropsychological and psychological tests

Sponsors & Collaborators

  • Institut de Recherche sur la Moelle épinière et l'Encéphale

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-01
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03811626 on ClinicalTrials.gov