Mild Traumatic Brain InjuryNCT03811626
Efficacy of Multidimensional Management of Mild Traumatic Brain Injury
A study testing cognitive-behavioral rehabilitation in people with Mild Traumatic Brain Injury, run by Institut de Recherche sur la Moelle épinière et l'Encéphale at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- cognitive-behavioral rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 6 sitesFrance
- Study dates
- 1 Apr 2012to 30 Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Patient with a neurological disorder
- Patient with substance dependence
- Subject under guardianship or wardship
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Chu Bicetre
Le Kremlin-Bicêtre
Chu Montpellier
Montpellier
Chu Bichat/Beaujon
Paris
CHU St ANTOINE
Paris
Chu Tenon
Paris
Chu Rouen
Rouen
About this study
Official title: Efficacy of Multidimensional Management of Mild Traumatic Brain Injury : A Randomised Clinical Trial
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
- Being tested
- cognitive-behavioral rehabilitation
- Keywords
- Mild TBI, quality of life, coping strategies, symptoms, neuropsychological tests, pain, memory reactive, Cognitive dimension
- Medical subject headings
- Brain Concussion, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive-behavioral rehabilitationProcedure or surgery
Combination of clinical examination and neuropsychological and psychological tests
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patient who underwent cognitive-behavioral rehabilitation Receives: Procedure: cognitive-behavioral rehabilitation |
| Comparator | No intervention | Patient with no specific management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months -
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 Apr 2012
- Primary completion30 Jun 2013
- Study completion30 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche sur la Moelle épinière et l'Encéphale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811626
- Sponsor's protocol ID
- 2012-A00015-38
- Status last verified
- Jan 2019
- First submitted
- 18 Jan 2019
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31551902
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Multidimensional Management of Mild Traumatic Brain Injury : A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03811626
- Acronym / sponsor ID
- 2012-A00015-38
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Mild TBI, quality of life, coping strategies, symptoms, neuropsychological tests, pain, memory reactive, Cognitive dimension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Institut de Recherche sur la Moelle épinière et l'EncéphaleUniversity, hospital or other
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- 30 Jun 2013 (actual)
- Study completion
- 30 Jun 2013 (actual)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: cognitive-behavioral rehabilitationPatient who underwent cognitive-behavioral rehabilitation |
| Comparator | No intervention | –Patient with no specific management |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive-behavioral rehabilitationCombination of clinical examination and neuropsychological and psychological tests | Procedure or surgery | Intervention |
Primary outcome
Change in quality of life
Time frame: Baseline, 6 months -
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Derived from this study: PubMed 31551902Caplain 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.
- Early Detection of Poor Outcome after Mild Traumatic Brain Injury: Predictive Factors Using a Multidimensional Approach a Pilot Study.Link provided by the sponsor.
Related trials for Mild Traumatic Brain Injury
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive-behavioral rehabilitation in people with Mild Traumatic Brain Injury, run by Institut de Recherche sur la Moelle épinière et l'Encéphale at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life (time frame: Baseline, 6 months -). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03811626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.