Actively Recruiting
Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study
Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2026-03-05
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
I
Institut National de la Santé Et de la Recherche Médicale, France
Lead Sponsor
I
Institut National de Recherche en Informatique et en Automatique
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of mild traumatic brain injury (concussion) in young children aged 3 to under 6 years. This observational study compares 30 children who had a concussion to 30 children with an orthopedic injury to an arm or leg, to understand how concussions affect brain structure, function, and behavior during this critical period of brain development. The study involves two groups: children with a concussion and children with an orthopedic injury, both aged between 3 and just under 6 years. Each child will undergo a non-sedated MRI scan to examine brain structure and function. The children are recruited from a pediatric emergency department shortly after injury, and their brain changes will be compared between the two groups. Participants will have brain imaging performed around 3 months after their injury to measure persistent brain structure changes, brain lesion volume and number, blood flow alterations, and the integrity of brain networks. The study will collect detailed brain scans and behavioral data to assess any lasting effects of concussion in young children. The total duration of participation spans from injury to follow-up imaging at 3 months.
CONDITIONS
Brief Title
Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged between 36 months (3 years) and 71 months and 31 days (just before 6 years old)
- Presented to the emergency department within 48 hours after injury
- For concussion group: unintentional non-penetrating head injury diagnosed as mild traumatic brain injury (mTBI) by WHO criteria
- For control group: unintentional injury to an upper or lower limb diagnosed as simple fracture, sprain, contusion, or mild trauma
- Parent or guardian fluent in French
You will not qualify if you...
- Previous diagnosis of any traumatic brain injury
- Intentional injury
- Use of sedative drugs that affect brain function
- Complications following injury
- Contraindications to MRI
- Prematurity
- Severe neurological, developmental, or psychiatric disorders
- Children in foster care at the time of recruitment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 48 hours after injury
Participants undergo a non-sedated MRI scan to assess brain structure and function following injury.
1 visit (in-person)
Duration - 3 months post-injury
Participants are observed for persistent brain structure and function alterations three months post-injury.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Unité des urgences médicochirurgicales CHU Rennes
Rennes, France, 35200
Actively Recruiting
Research Team
F
Fanny DÉGEILH, PhD
V
Véronique CHASLE, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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