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Recruiting Not applicable

Interest of the 7 Tesla MRI in the Diagnosis of Post-concussion Syndromes Among Patients With Mild Traumatic Brain Injury

NCT04982562 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-06-26
Last updated
2026-05-22

Condition(s) studied

Post-Concussion Syndrome

Investigational drug(s) / intervention(s)

7T MRI

7T MRI: Seven tesla brain MRI (7T MRI) at day 7 in patients suffering from post concussionnal symptoms after mild traumatic brain injury admitted to emergency departement of Poitiers CHU (University Hospital

Study summary

We aimed to conduct a prospective longitudinal interventionnal monocentric study to assess the ability of seven tesla MRI to detect diffuses axonal lesions in patients presenting a post concussional syndrom (PCS) at seven days about a mild traumatic brain injury (MTBI). Our first objective was to evaluate the diagnostic performance of seven tesla MRI runned at seven days after MTBI among patients presenting a PCS.

Eligibility

Sex
ALL
Min age
20 Years
Max age
72 Years
Healthy volunteers
No
Inclusion Criteria: * Mild traumatic brain injury with glascow included between 13 and 15, with indication of scan * possibilty of performing an MRI at 7 days * Patient able to get to MRI at Day 7 * Free consentement to the study * Any measure of guardianship or curatorship , any link of subordination Exclusion Criteria: * Patient does not hospitalized about head trauma * Inhability to move out for run the seven day MRI * Contraindication for MRI * Patient having already consulted the emergency for head trauma requiring imaging * Patients with psychiatric troubles : bipolarity, panic trouble, depressive trouble, schizophrenia * Patient already enrolled in the study * History of brain, tumor or neurosurgery * Untreated or poorly treated chronic vertigo * Untreated or poorly treated chronic migraines * Claustrophobia * BMI \> 40 * Refusal of consent to take part of the study * No social welfare or inhability to benefit of it by a third party * Patients with enhanced protection : minor aged under 18 ; person with freedom restriction by justice decision or administrative ; homeliving in health or social establishment ; adult in legal protection * Pregnant and nursing women

Primary outcome measure(s)

  • Determine the diagnostic performance of 7 Tesla MRI performed of mild head trauma for the occurrence of post-concussion syndrome (PCS) — Day 7
    appearance of diffuse axonal lesions

Trial sites (1)

FacilityCityRegionStatus
CHU Poitiers Poitiers France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04982562 on ClinicalTrials.gov ↗ ← All trials in France