Examining brain development in young children after mild traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the impact of mild traumatic brain injury (mTBI) on brain structure, function, and behavior in children aged 3 to 5 years. By comparing a group of 30 children who have sustained a concussion with another group of 30 children who have experienced an orthopedic injury, researchers will utilize brain imaging techniques to assess potential differences. The study seeks to enhance understanding of how concussions affect young children's developing brains, which may differ significantly from older children. The findings could provide valuable insights into the long-term consequences of mTBI in early childhood.

Why it matters

Who can join: the full rules

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

Where it's running

• Unité des urgences médicochirurgicales CHU Rennes
  Rennes, France Recruiting

Study contacts

• Study coordinator: Fanny DÉGEILH, PhD
• Email: fanny.degeilh@inserm.fr
• Phone: +33 2 99 84 71 63

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ReVIVE for mTBI: Using VR and therapy to help adults with mild traumatic brain injury

  This study tests a virtual reality therapy combined with standard psychotherapy to see if it can reduce PTSD symptoms and improve executive function in adults with mild traumatic brain injury.

  Recruiting Phase 1 Johns Hopkins University · Baltimore, Maryland · NCT07890337

• Fibrinogen-to-Albumin Ratio as a Predictor of ARDS in Traumatic Brain Injury

  This study tests whether the fibrinogen-to-albumin ratio can predict who among adults with traumatic brain injury will develop acute respiratory distress syndrome (ARDS).

  Recruiting Tanta University · Tanta, Gharbia Governorate · NCT07664358

• Support-TBI: Testing a partner-based program to help people with traumatic brain injury stay connected

  A small pilot test will see if a partnered person with TBI and a close supporter can successfully participate in a 12-week program to improve social support and daily life participation.

  Recruiting Phase 1 Washington University School of Medicine · St Louis, Missouri · NCT07625098

• ENGAGE-TBI: A Feasibility Program to Reduce Social Isolation for Adults with Traumatic Brain Injury

  We’re testing a 12-session group program to help adults with traumatic brain injury in the community build social participation and reduce isolation.

  Recruiting Phase 1 Washington University School of Medicine · St Louis, Missouri · NCT07549997

• Can a bedside brain scan (fNIRS) detect activity in healthy people and in people with disorders of consciousness

  This observational study tests whether functional near-infrared spectroscopy (fNIRS) can measure brain activity at the bedside in healthy adults and in patients with disorders of consciousness in the Neuro-ICU.

  Recruiting University of California, Los Angeles · Los Angeles, California · NCT07485361

• Long-lasting effects of hyperbaric oxygen therapy on thinking after traumatic brain injury

  This project will see if people with traumatic brain injury who completed a course of hyperbaric oxygen therapy 1–4 years ago still have improved thinking and memory.

  Recruiting Assaf-Harofeh Medical Center · Zrifin · NCT07430150

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.