Efficacy of Multidimensional Management of Mild Traumatic Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-01

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Mild Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

Patient who underwent cognitive-behavioral rehabilitation

Group Type EXPERIMENTAL

cognitive-behavioral rehabilitation

Intervention Type PROCEDURE

Combination of clinical examination and neuropsychological and psychological tests

Comparator

Patient with no specific management

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cognitive-behavioral rehabilitation

Combination of clinical examination and neuropsychological and psychological tests

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No