Interest of the 7 Tesla MRI in the Diagnosis of Post-concussion Syndromes

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Among patients admitted in emergency care units in France for mild traumatic brain injury, 10 % will develop post concussionnal symptoms. The variability of the clinical presentation lead to a syndrome at the border of neurology, psychiatry and neuro-traumatology. Ninety per cent of these patients will have a favorable evolution in three to six months while ten per cent will have persistant symptoms : dizziness, headache, nausea, drowsiness, anxio-depressive symptoms, irritability, memory impairments, attentionnal disorders. This conduct to an additionnal medical and social cost (medical re-consultation in emergency services, pharmaceutical expenditure due to over medication, social recognition, deterioration of social and professionnal relationships …). The litterature data show the presence of diffuse axonal lesions (DAL) frequently observed in patients victims of MTBI. These lesions seemed to be correlate with the occurrence of post concussional symptoms. New brain imagery have lead to these discoveries but are not relevant in clinical routine (functionnal MRI, Diffusion Tensor Imaging, tractography). Computed Tomography is often normal and not able to detect these lesions. Standard MRI is not enough sensible for the detection of the DAL. Some autor shows alose that his sensibility decrease in time. These observations and encouraging results lead us to initiate a prospective interventionnal, longitudinal, pilot study monocentric using seven tesla MRI to evaluate its input in the detection of diffuse axonal lesions among patients presenting post concussionnal symptoms after a mild traumatic brain injury at day seven after they are admitted to our emergency service. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04982562
Study type	Interventional
Source	Poitiers University Hospital
Contact	Jeremy GUENEZAN, Dr
Phone	05 49 44 44 44
Email	jeremy.guenezan@chu-poitiers.fr
Status	Recruiting
Phase	N/A
Start date	June 26, 2021
Completion date	June 26, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms