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Clinical Trials/NCT04364568
NCT04364568
Terminated
Not Applicable

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

University Hospital, Grenoble1 site in 1 country11 target enrollmentJuly 2, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
University Hospital, Grenoble
Enrollment
11
Locations
1
Primary Endpoint
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.
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2, 2021
End Date
May 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

Time Frame: 3 months

Mean of cerebral volume fraction corresponding to lesions areas, found in multiparametrical magnetic resonance imaging (expressed as a percentage), 3 months after mild traumatic brain injury.

Secondary Outcomes

  • Clinical correlation of magnetic resonance imaging with symptoms.(3 months)
  • Describe in both groups, the evolution of symptomatology at one year(12 months)
  • Evaluate the impact of mTBI on patients' lifestyles(12 months)
  • Evaluate the impact of social characteristics and the resources mobilized(12 months)
  • Describe correlation between anamnestic risk factors, demographic data and post-concussion syndrome occurence(3 months)
  • 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.(3 months)
  • Graph metrics in resting-state functional magnetic resonance imaging in both groups(3 months)
  • Evaluate the impact of social characteristics at stake and the resources mobilized(6 months)
  • 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.(12 months)

Study Sites (1)

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