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

TBI (Traumatic Brain Injury) Clinical Trial

— KAOUENN  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06024122
• Other study ID #: C22-48
• Secondary ID: 2022-A02619-34
• Status: Not yet recruiting
• Start date: September 2, 2023
• Est. completion date: February 27, 2025

Study information

• Verified date: June 2023
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Fanny DÉGEILH, PhD
• Phone: +33 2 99 84 71 63
• Email: fanny.degeilh[@]inserm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 27, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Months to 71 Months

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• TBI (Traumatic Brain Injury)
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
France	Unité des urgences médicochirurgicales CHU Rennes	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	Institut National de Recherche en Informatique et en Automatique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute and persistent post-concussive symptoms	Assessment of post-concussive symptoms using the REACTIONS questionnaire	Through study completion, an average of 3 months
Other	Persistent behavioural difficulties	Assessment of behaviour using the Strengths and Difficulties Questionnaire	3 months post-injury
Primary	Persistent brain structure alterations	Quantitative assessment of the brain morphometry extracted from T1-w MRI sequence	3 months post-injury
Secondary	Persistent brain lesions - Volume	Volume of brain lesions measured with susceptibility MRI	3 months post-injury
Secondary	Persistent brain lesions - Number	Number brain lesions measured with susceptibility MRI	3 months post-injury
Secondary	Cerebral blood flow alteration	Cerebral blood flow quantified by arterial spin labelling perfusion MRI (ASL)	3 months post-injury
Secondary	Functional integrity of brain networks	Functional connectivity (i.e., correlation between the activation of brain regions) measured by resting-state functional MRI	3 months post-injury
Secondary	Structural integrity of brain networks	White matter micro-structure measured by diffusion MRI	3 months post-injury