Efficacy of Multidimensional Management of Mild Traumatic Brain Injury

Mild Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03811626
• Other study ID #: 2012-A00015-38
• Status: Completed
• Phase: N/A
• Start date: April 1, 2012
• Est. completion date: June 30, 2013

Study information

• Verified date: January 2019
• Source: Institut de Recherche sur la Moelle épinière et l'Encéphale
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: June 30, 2013
• Est. primary completion date: June 30, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Wounds and Injuries

Intervention

Procedure:
• cognitive-behavioral rehabilitation
Combination of clinical examination and neuropsychological and psychological tests

Locations

Country	Name	City	State
France	Chu Bicetre	Le Kremlin-Bicêtre
France	Chu Montpellier	Montpellier
France	Chu Bichat/Beaujon	Paris
France	CHU St ANTOINE	Paris
France	Chu Tenon	Paris
France	Chu Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherche sur la Moelle épinière et l'Encéphale

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life	Change in quality of life assessed by QOLIBRI (Quality of Life after Brain Injury) Scale - QOLIBRI scale assess health-related quality of life (HRQoL) of individuals after traumatic brain injury. QOLIBRI is a comprehensive questionnaire with 37 items covering six dimensions of HRQoL after TBI. The QOLIBRI scores are reported on a 0-100 scale , where 0=worst possible quality of life and 100=best possible quality of life.	Baseline, 6 months -

External Links

•   Early Detection of Poor Outcome after Mild Traumatic Brain Injury: Predictive Factors Using a Multidimensional Approach a Pilot Study.