Unité des urgences médicochirurgicales CHU Rennes
Rennes, 35200, France
Location status: Recruiting
NCT Number: NCT06024122
Concussions (also known as mild traumatic brain injury) are common in young children. In some children, they can lead to short- and long-term difficulties. However, our knowledge of the exact consequences of injuries on young children's brains and behavior is limited. These consequences may be different in children under 6, as their brains are fragile and undergoing significant developmental changes.
The aim of this study is to determine the extent to which a concussion sustained before the age of 6 years is associated with changes in young children's brain structure, function and behaviours, using a brain imaging.
In this study, the results of a group of 30 children with a concussion will be compared to those of 30 children of the same age with an orthopaedic injury to the upper or lower limbs.
Interested in participating?
Request Info36 month–71 month
All sexes
Observational
Rennes, 35200, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A non-sedated MRI scan will be performed to assess the structure and function of the children's brains
Time frame: 3 months post-injury
Quantitative assessment of the brain morphometry extracted from T1-w MRI sequence
Time frame: 3 months post-injury
Volume of brain lesions measured with susceptibility MRI
Time frame: 3 months post-injury
Number brain lesions measured with susceptibility MRI
Time frame: 3 months post-injury
Cerebral blood flow quantified by arterial spin labelling perfusion MRI (ASL)
Time frame: 3 months post-injury
Functional connectivity (i.e., correlation between the activation of brain regions) measured by resting-state functional MRI
Time frame: 3 months post-injury
White matter micro-structure measured by diffusion MRI
Time frame: Through study completion, an average of 3 months
Assessment of post-concussive symptoms using the REACTIONS questionnaire
Time frame: 3 months post-injury
Assessment of behaviour using the Strengths and Difficulties Questionnaire
Contact information is provided by the study sponsor or research team.
Fanny DÉGEILH, PhD
CONTACT
Véronique CHASLE, MD
CONTACT
Institut National de la Santé Et de la Recherche Médicale, France
Other Gov
Acronym: KAOUENN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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