- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03342612
Multimodal Neuroimaging Analysis After Mild Traumatic Brain Injury (CHANGE-TBI)
Cerebral Microstructural and Functional Changes After Single and Repeated Mild Traumatic Brain Injury
Mild Traumatic Brain Injury (mTBI), including concussion, is a real public health problem. Indeed mTBI might induce long-term brain disorders with increased risk of neurodegenerative diseases and the healthcare costs can be significant for both the individual and the society. However mTBI is called the "silent epidemic", because of the lack of research in this field in France as well as in the rest of the world. Most of the time, mTBI is associated with sports injuries, road traffic accidents and falls. The risk of neurodegenerative diseases is significantly increased with the repetition of mTBI, which may have a cumulative effect. In this context, playing football (or 'soccer') is associated with a high risk of concussion and with frequent head-ball contacts which are repeated during the training and matches. Moreover, football is the most popular team sport in the world, with more than 265 million players. The long-term impact of "heading" in football is still debated in the literature. Nevertheless, several studies suggest the possible emergence of early neurocognitive disorders. Otherwise, while mTBI is usually characterized by normal brain images using traditional neuroimaging techniques, microscopic anatomical changes might be detectable by new neuroimaging techniques. According to recent studies, cognitive dysfunctions could be based on these microstructural changes in the gray matter and white matter, secondary to the primary mechanical injury. Studies that have examined the structural changes in the brain white matter in football players are rare and lack of evidence regarding the consequences of accumulated brain impacts explains the lack of preventive measures in this sport. In addition, post-traumatic secondary lesions cause functional alterations of the neurovascular unit and its effect on cerebral perfusion may play a crucial role, which has never been yet explored in humans over the long term.
In this research, the investigators will develop a unique multi-modal neuroimaging protocols to assess brain changes after minor head trauma and over the time. Investigators want to perform magnetic resonance imaging (MRI) to assess cerebral blood flow using Arteria Spin Labelling (ASL), structural changes using Diffusion Tensor Imaging (DTI), susceptibility weighted imaging (SWI), and functional changes using BOLD resting-functional MRI.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bordeaux, France, 33076
- University Hospital Bordeaux
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Applicable to all :
- Male 18 to 25 years, enrolled in French Social Security.
Group of mTBI patients:
- Diagnosis of mTBI in the last 2 weeks confirmed in emergency department of Bordeaux CHU, using the WHO definition (2004): "head trauma ≤ 24h with Glasgow Coma Scale score of 13-15 and with one or more of the three symptoms following: confusion or disorientation, loss of consciousness for 30 minutes or less, posttraumatic amnesia for less than 24h".
Group of footballers:
- Member of the "CFA" and "U19" teams of "Girondins de Bordeaux".
Group of controls:
- Practicing regular physical activity (excluding combat or contact sports).
Exclusion Criteria :
- Abnormal neurological examination
- Drug addiction including alcohol Taking drugs targeting the central nervous system History of head trauma, or other notion of central nervous system injury
- History of severe high blood pressure, diabetes, chronic cardiovascular pathology, progressive or debilitating disease
- Subject unable to give informed consent
- Contraindication to MRI: head circumference> 60 - Claustrophobia - Pacemaker, Implantable Neurostimulation, Implantable Defibrillator - Cochlear Implants - Ocular or cerebral ferromagnetic foreign body
- Refusal to be informed of an abnormality detected during MRI.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brain Magnetic Resonance Imaging (MRI)
Neuroimaging protocol to assess brain changes after minor head trauma and over the time.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fractional anisotropy (FA) measure
Time Frame: Month 0
|
Fractional anisotropy (FA) measure by Magnetic Resonance Imaging
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Month 0
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Fractional anisotropy (FA) measure by Magnetic Resonance Imaging
Time Frame: Month 12
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Fractional anisotropy (FA) measure by Magnetic Resonance Imaging
|
Month 12
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Radial diffusivity (RD) measure
Time Frame: Month 0
|
Radial diffusivity (RD) measure by Magnetic Resonance Imaging
|
Month 0
|
Radial diffusivity (RD) measure
Time Frame: Month 12
|
Radial diffusivity (RD) measure by Magnetic Resonance Imaging
|
Month 12
|
Mean diffusivity (MD) measure
Time Frame: Month 0
|
Mean diffusivity (MD) measure by Magnetic Resonance Imaging
|
Month 0
|
Mean diffusivity (MD) measure
Time Frame: Month 12
|
Mean diffusivity (MD) measure by Magnetic Resonance Imaging
|
Month 12
|
Axial diffusivity (AD) measure
Time Frame: Month 0
|
Axial diffusivity (AD) measure by Magnetic Resonance Imaging
|
Month 0
|
Axial diffusivity (AD) measure
Time Frame: Month 12
|
Axial diffusivity (AD) measure by Magnetic Resonance Imaging
|
Month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain areas on MRI sequences
Time Frame: Month 0
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Month 0
|
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Brain areas on MRI sequences
Time Frame: Month 12
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Month 12
|
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Brain's white matter injury volume on MRI
Time Frame: Month 0
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Month 0
|
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Brain's white matter injury volume on MRI
Time Frame: Month 12
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Month 12
|
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Micro-bleedings measure
Time Frame: Month 0
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Micro-bleedings measure on MRI in the brain parenchyma
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Month 0
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Micro-bleedings measure
Time Frame: Month 12
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Micro-bleedings measure on MRI in the brain parenchyma
|
Month 12
|
Blood brain circulation on MRI
Time Frame: Month 0
|
Month 0
|
|
Blood brain circulation on MRI
Time Frame: Month 12
|
Month 12
|
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Connectivity modification of on MRI
Time Frame: Month 0
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Month 0
|
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Connectivity modification of on MRI
Time Frame: Month 12
|
Month 12
|
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Actimetry
Time Frame: Month 0
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Month 0
|
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Actimetry
Time Frame: Month 12
|
Month 12
|
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Cognitive performances and emotional state by Ecological Momentary Assessment (EMA)
Time Frame: Month 0
|
Month 0
|
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Cognitive performances and emotional state by Ecological Momentary Assessment (EMA)
Time Frame: Month 12
|
Month 12
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX2016/07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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