Clinical trial NCT04364568: Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion
Official title: Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Regional Council of Auvergne-Rhône-Alpes
First posted: 2020-04-28
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, monocentric, etiological cohort study
Primary purpose: DIAGNOSTIC

Brief summary: Minor traumatic brain injury (mTBI) (Glasgow Coma Scale 13 to 15) represent 70 to 90% of traumatic brain injury. Different disorders may occur after a traumatic minor brain injury (somatic, cognitive or affective) within 2 weeks.

For 10 to 20% these symptoms are persistent and are part of post-concussion syndrome. Today a small amount of tools to predict this syndrome are available. Cerebral CT scan, a routine test for mTBI, isn't relevant to predict the post concussion syndrome.

In order to improve understanding of the evolution toward this complication, it seems relevant to run a multimodal study.

Multiparameter MRI combined to psychological and sociological evaluations cold provide a better global perception.


Eligibility criteria: Inclusion Criteria:

* Patients who answered to psychological questionnaires 3 month after mTBI
* Patients with mTBI according to European Federation of Neurological Societies
* Initial CT scan indication according to 2012 French Society of Emergency Medicine and European Federation of Neurological Societies
* Health insurance
* Written consent

Exclusion Criteria:

* Under 18 years
* Psychiatric or neurologic history with long term treatment
* Hospitalization due to extra-cranial wounds or intoxication (except alcool)
* MTBI due to aggression
* MRI contraindication
* Inability to understand french language
* Pregnant or breastfeeding women
* Incapacitated patients in accordance with article L 1121-5 to L1121-8 of the public health code
* Patients in another study's exclusion time
* Inability to have a follow-up
* Patients who can't be reached in case of emergency

Primary outcomes:
measure: Compare the mean lesion volume fraction found in multiparametric magnetic resonance imaging between patients with and without post-concussions syndrome, three months after a mild Traumatic Brain Injury.
timeFrame: 3 months
Secondary outcomes:
measure: Describe correlation between anamnestic risk factors, demographic data and post-concussion syndrome occurence
timeFrame: 3 months
measure: Level of asymmetry of the signal between each hemisphere, for each magnetic resonance imagings equence, and with the techniques of ROI (Regions of Interests): asymmetry threshold corresponding to a lesion.
timeFrame: 3 months
measure: Graph metrics in resting-state functional magnetic resonance imaging in both groups
timeFrame: 3 months
measure: Clinical correlation of magnetic resonance imaging with symptoms.
timeFrame: 3 months
measure: Describe in both groups, the evolution of symptomatology at one year
timeFrame: 12 months
measure: Evaluate the impact of mTBI on patients' lifestyles
timeFrame: 6 months
measure: Evaluate the impact of mTBI on patients' lifestyles
timeFrame: 12 months
measure: Evaluate the impact of social characteristics at stake and the resources mobilized
timeFrame: 6 months
measure: Evaluate the impact of social characteristics and the resources mobilized
timeFrame: 12 months
measure: Evaluate the experience of mTBI and post-concussion syndrome through the patient's personal appreciation, the judgement of family and friends and the medical follow-up of the general practitioner.
timeFrame: 6 months
measure: Evaluate the experience of mTBI and post-concussion syndrome through the patient's personal appreciation, the judgement of family and friends and the medical follow-up of the general practitioner.
timeFrame: 12 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Chu Grenoble Alpes
Study officials:
References: