Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion (TRACE)

Grenoble Alpes University Hospital Center (CHU)

Status: Terminated

Conditions: Traumatic Brain Injury

Treatments: Radiation: Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT04364568

38RC19.305

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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11 participants in 2 patient groups

Symptomatic group at three month

Experimental group

Description:

Rivermead Post-Concussion Syndrome \>= 12 MRI and clinical exam and sociological interview at day 105 (+/-15 days) 6 months follow up : sociological interview 1 year follow up : psychological and sociological interview, Rivermead Post Concussion Syndrome questionnaire

Treatment:

Radiation: Magnetic Resonance Imaging

Asymptomatic group at three month

Experimental group

Description:

Rivermead Post-Concussion Syndrome \< 12 MRI and clinical exam and sociological interview at day 105 (+/-15 days) 6 months follow up : sociological interview 1 year follow up : psychological and sociological interview, Rivermead Post Concussion Syndrome questionnaire

Treatment:

Radiation: Magnetic Resonance Imaging