Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion
NCT ID: NCT04364568
Last Updated: 2024-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
11 participants
INTERVENTIONAL
2021-07-02
2024-05-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Symptomatic group at three month
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
Magnetic Resonance Imaging
IRM Sequences T1, T2, FLAIR, T2\*, Cerebral Blood Flow (CBF) et mean diffusivity (MD)
Asymptomatic group at three month
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
Magnetic Resonance Imaging
IRM Sequences T1, T2, FLAIR, T2\*, Cerebral Blood Flow (CBF) et mean diffusivity (MD)
Interventions
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Magnetic Resonance Imaging
IRM Sequences T1, T2, FLAIR, T2\*, Cerebral Blood Flow (CBF) et mean diffusivity (MD)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Regional Council of Auvergne-Rhône-Alpes
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
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Locations
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Chu Grenoble Alpes
Grenoble, , France
Countries
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Other Identifiers
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38RC19.305
Identifier Type: -
Identifier Source: org_study_id
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