Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study

NCT06024122 | Recruiting

• 2 other identifiers: C22-482022-A02619-34
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

TBI (Traumatic Brain Injury)

Outcome Measures

Primary Outcomes (1)

• Persistent brain structure alterations

  Quantitative assessment of the brain morphometry extracted from T1-w MRI sequence

  3 months post-injury

Secondary Outcomes (5)

• Persistent brain lesions - Volume

  3 months post-injury

• Persistent brain lesions - Number

  3 months post-injury

• Cerebral blood flow alteration

  3 months post-injury

• Functional integrity of brain networks

  3 months post-injury

• Structural integrity of brain networks

  3 months post-injury

Other Outcomes (2)

• Acute and persistent post-concussive symptoms

  Through study completion, an average of 3 months

• Persistent behavioural difficulties

  3 months post-injury

Study Arms (2)

Patients with a mTBI

Children with a mTBI aged 3 to 5 years (i.e., up to 71 months and 31 days, i.e., before the 6th birthday) recruited from the paediatric emergency department of Rennes University Hospital.

Other: IRM exam

Control with an orthopaedic injury

Children with an orthopaedic injury aged 3 to 5 years (i.e., up to 71 months and 31 days, i.e., before the 6th birthday) recruited from the paediatric emergency department of Rennes University Hospital.

Other: IRM exam

Interventions

IRM exam OTHER

A non-sedated MRI scan will be performed to assess the structure and function of the children's brains

Control with an orthopaedic injury; Patients with a mTBI

Eligibility Criteria

• Age: 36 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday) with mTBI. Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday) with orthopaedic injury (simple fracture, sprain, contusion or unspecified trauma to a limb (mild))

You may qualify if:

• Patient group with mild traumatic brain injury (mTBI) :
• Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday)
• Presentation to the emergency department within 48 hours post-injury
• Documented, unintentional traumatic event (e.g. blow, fall, etc.) resulting in non-penetrating head injury
• Diagnosis of mTBI (World Health Organization (WHO) paediatric diagnostic criteria)
• Control group with orthopaedic injury:
• Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday)
• Presentation to the emergency department within 48 hours post-injury
• Documented, unintentional traumatic event (e.g. blow, fall, etc.) resulting in trauma to an upper or lower limb
• Diagnosis of simple fracture, sprain, contusion or unspecified trauma to a limb (mild).

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• Institut National de Recherche en Informatique et en Automatique: collaborator

Study Sites (1)

Unité des urgences médicochirurgicales CHU Rennes

Rennes, 35200, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Fanny DÉGEILH, PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

Central Study Contacts

Fanny DÉGEILH, PhD

CONTACT

+33 2 99 84 71 63; fanny.degeilh@inserm.fr

Véronique CHASLE, MD

CONTACT

+33 2 99 26 67 58; veronique.chasle@chu-rennes.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: September 6, 2023
• Study Start: July 3, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

FR (1)