TBI (Traumatic Brain Injury)KAOUENNNCT06024122
Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study
An observational study of TBI (Traumatic Brain Injury), run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 36 to 71 months
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- IRM exam
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 71 months
- All sexes
- No healthy volunteers
- Child
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))
Who may be able to join
- 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:
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- 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).
Who cannot join
- 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,
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- Prematurity,
- Diagnosis of a severe neurological, developmental, or psychiatric disorder
- Children in foster care at the time of recruitment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Unité des urgences médicochirurgicales CHU Rennes
Rennes, 35200
Véronique Chasle, MD, +33 2 99 26 67 58, veronique.chasle@chu-rennes.fr
About this study
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)
- Being tested
- IRM exam
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRM examOther
A non-sedated MRI scan will be performed to assess the structure and function of the children's brains
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: IRM exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent brain structure alterations
Quantitative assessment of the brain morphometry extracted from T1-w MRI sequence
Measured: 3 months post-injury
Secondary outcomes (5)
Persistent brain lesions - Volume
Volume of brain lesions measured with susceptibility MRI
Measured: 3 months post-injury
Persistent brain lesions - Number
Number brain lesions measured with susceptibility MRI
Measured: 3 months post-injury
Cerebral blood flow alteration
Cerebral blood flow quantified by arterial spin labelling perfusion MRI (ASL)
Measured: 3 months post-injury
Functional integrity of brain networks
Functional connectivity (i.e., correlation between the activation of brain regions) measured by resting-state functional MRI
Measured: 3 months post-injury
Structural integrity of brain networks
White matter micro-structure measured by diffusion MRI
Measured: 3 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start3 Jul 2024
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Institut National de Recherche en Informatique et en Automatique
- Responsible party
- Sponsor
- Investigators
- Fanny DÉGEILH, PhD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024122
- Sponsor's protocol ID
- C22-48
- Other IDs
- 2022-A02619-34
- Acronym
- KAOUENN
- Status last verified
- Mar 2026
- First submitted
- 7 Jul 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study
- ClinicalTrials.gov ID
- NCT06024122
- Acronym / sponsor ID
- KAOUENN / C22-48
- Conditions
- TBI (Traumatic Brain Injury)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Institut National de Recherche en Informatique et en Automatique
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with a mTBI | – | Other: IRM examChildren 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. |
| Control with an orthopaedic injury | – | Other: IRM examChildren 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. |
Who may qualify
- Ages
- 36 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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))
Key inclusion criteria (10 listed)
- Patient group with mild traumatic brain injury (mTBI) :
- Control group with orthopaedic injury:
Key exclusion criteria (9 listed)
- Diagnosis of previous TBI (any severity, any age)
- Intentional injury,
- Administration of sedative drugs that can alter brain function
- Complications following injury
- MRI contraindication,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRM examA non-sedated MRI scan will be performed to assess the structure and function of the children's brains | Other | Control with an orthopaedic injury, Patients with a mTBI |
Primary outcome
Persistent brain structure alterations
Time frame: 3 months post-injury
Quantitative assessment of the brain morphometry extracted from T1-w MRI sequence
5 secondary outcomes
Persistent brain lesions - Volume
Time frame: 3 months post-injury
Persistent brain lesions - Number
Time frame: 3 months post-injury
Cerebral blood flow alteration
Time frame: 3 months post-injury
Functional integrity of brain networks
Time frame: 3 months post-injury
Structural integrity of brain networks
Time frame: 3 months post-injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fanny DÉGEILH, PhD study director
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TBI (Traumatic Brain Injury), run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fanny DÉGEILH, PhD (+33 2 99 84 71 63, fanny.degeilh@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent brain structure alterations (time frame: 3 months post-injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.