NCT06024122 Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study
| NCT ID | NCT06024122 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
| Condition | TBI (Traumatic Brain Injury) |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-07-03 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-07-03 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patient group with mild traumatic brain injury (mTBI) : 1. Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday) 2. Presentation to the emergency department within 48 hours post-injury 3. Documented, unintentional traumatic event (e.g. blow, fall, etc.) resulting in non-penetrating head injury 4. Diagnosis of mTBI (World Health Organization (WHO) paediatric diagnostic criteria) * Control group with orthopaedic injury: 1. Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday) 2. Presentation to the emergency department within 48 hours post-injury 3. Documented, unintentional traumatic event (e.g. blow, fall, etc.) resulting in trauma to an upper or lower limb 4. Diagnosis of simple fracture, sprain, contusion or unspecified trauma to a limb (mild). Exclusion Criteria: * Diagnosis of previous TBI (any severity, any age) * Intentional injury, * Administration of sedative drugs that can alter brain function * Complications following injury * MRI contraindication, * Parent non-fluent in French, * Prematurity, * Diagnosis of a severe neurological, developmental, or psychiatric disorder * Children in foster care at the time of recruitment
Contact & Investigator
Fanny DÉGEILH, PhD
STUDY DIRECTOR
Institut National de la Santé Et de la Recherche Médicale, France
Frequently Asked Questions
Who can join the NCT06024122 clinical trial?
This trial is open to participants of all sexes, aged 36 Months or older, up to 71 Months, studying TBI (Traumatic Brain Injury). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06024122 currently recruiting?
Yes, NCT06024122 is actively recruiting participants. Contact the research team at fanny.degeilh@inserm.fr for enrollment information.
Where is the NCT06024122 trial being conducted?
This trial is being conducted at Rennes, France.
Who is sponsoring the NCT06024122 clinical trial?
NCT06024122 is sponsored by Institut National de la Santé Et de la Recherche Médicale, France. The principal investigator is Fanny DÉGEILH, PhD at Institut National de la Santé Et de la Recherche Médicale, France. The trial plans to enroll 60 participants.