Efficacy of Multidimensional Management of Mild Traumatic Brain Injury

NCT03811626 | Completed

• 1 other identifier: 2012-A00015-38
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Mild TBI; quality of life; coping strategies; symptoms; neuropsychological tests; pain; memory reactive; Cognitive dimension

Outcome Measures

Primary Outcomes (1)

• 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 -

Study Arms (2)

Intervention

EXPERIMENTAL

Patient who underwent cognitive-behavioral rehabilitation

Procedure: cognitive-behavioral rehabilitation

Comparator

NO INTERVENTION

Patient with no specific management

Interventions

cognitive-behavioral rehabilitation PROCEDURE

Combination of clinical examination and neuropsychological and psychological tests

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (6)

Chu Bicetre

Le Kremlin-Bicêtre, France

Location

Chu Montpellier

Montpellier, France

Location

Chu Bichat/Beaujon

Paris, France

Location

CHU St ANTOINE

Paris, France

Location

Chu Tenon

Paris, France

Location

Chu Rouen

Rouen, France

Location

Related Publications (1)

• Caplain S, Chenuc G, Blancho S, Marque S, Aghakhani N. Efficacy of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury for Preventing Post-concussional Syndrome in Individuals With High Risk of Poor Prognosis: A Randomized Clinical Trial. Front Neurol. 2019 Sep 4;10:929. doi: 10.3389/fneur.2019.00929. eCollection 2019.

  PMID: 31551902 DERIVED

Related Links

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

MeSH Terms

Conditions

Brain Concussion; Pain

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 22, 2019
• Study Start: April 1, 2012
• Primary Completion: June 30, 2013
• Study Completion: June 30, 2013
• Last Updated: January 24, 2019

Record last verified: 2019-01

Locations

FR (6)