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Multimodal Neuroimaging Analysis After Mild Traumatic Brain Injury (CHANGE-TBI)

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ClinicalTrials.gov Identifier: NCT03342612
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Procedure: Brain Magnetic Resonance Imaging (MRI) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Cerebral Microstructural and Functional Changes After Single and Repeated Mild Traumatic Brain Injury
Actual Study Start Date : July 18, 2016
Estimated Primary Completion Date : July 18, 2019
Estimated Study Completion Date : July 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brain Magnetic Resonance Imaging (MRI)
Neuroimaging protocol to assess brain changes after minor head trauma and over the time.
Procedure: Brain Magnetic Resonance Imaging (MRI)



Primary Outcome Measures :
  1. Fractional anisotropy (FA) measure [ Time Frame: Month 0 ]
    Fractional anisotropy (FA) measure by Magnetic Resonance Imaging

  2. Fractional anisotropy (FA) measure by Magnetic Resonance Imaging [ Time Frame: Month 12 ]
    Fractional anisotropy (FA) measure by Magnetic Resonance Imaging

  3. Radial diffusivity (RD) measure [ Time Frame: Month 0 ]
    Radial diffusivity (RD) measure by Magnetic Resonance Imaging

  4. Radial diffusivity (RD) measure [ Time Frame: Month 12 ]
    Radial diffusivity (RD) measure by Magnetic Resonance Imaging

  5. Mean diffusivity (MD) measure [ Time Frame: Month 0 ]
    Mean diffusivity (MD) measure by Magnetic Resonance Imaging

  6. Mean diffusivity (MD) measure [ Time Frame: Month 12 ]
    Mean diffusivity (MD) measure by Magnetic Resonance Imaging

  7. Axial diffusivity (AD) measure [ Time Frame: Month 0 ]
    Axial diffusivity (AD) measure by Magnetic Resonance Imaging

  8. Axial diffusivity (AD) measure [ Time Frame: Month 12 ]
    Axial diffusivity (AD) measure by Magnetic Resonance Imaging


Secondary Outcome Measures :
  1. Brain areas on MRI sequences [ Time Frame: Month 0 ]
  2. Brain areas on MRI sequences [ Time Frame: Month 12 ]
  3. Brain's white matter injury volume on MRI [ Time Frame: Month 0 ]
  4. Brain's white matter injury volume on MRI [ Time Frame: Month 12 ]
  5. Micro-bleedings measure [ Time Frame: Month 0 ]
    Micro-bleedings measure on MRI in the brain parenchyma

  6. Micro-bleedings measure [ Time Frame: Month 12 ]
    Micro-bleedings measure on MRI in the brain parenchyma

  7. Blood brain circulation on MRI [ Time Frame: Month 0 ]
  8. Blood brain circulation on MRI [ Time Frame: Month 12 ]
  9. Connectivity modification of on MRI [ Time Frame: Month 0 ]
  10. Connectivity modification of on MRI [ Time Frame: Month 12 ]
  11. Actimetry [ Time Frame: Month 0 ]
  12. Actimetry [ Time Frame: Month 12 ]
  13. Cognitive performances and emotional state by Ecological Momentary Assessment (EMA) [ Time Frame: Month 0 ]
  14. Cognitive performances and emotional state by Ecological Momentary Assessment (EMA) [ Time Frame: Month 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342612


Contacts
Contact: Igor SIBON 0556795520 igor.sibon@chu-bordeaux.fr
Contact: Caroline BUISSON 0556795540 caroline.buisson@chu-bordeaux.fr

Locations
France
University Hospital Bordeaux Recruiting
Bordeaux, France, 33076
Contact: Igor SIBON    0556795513    igor.sibon@u-bordeaux.fr   
Contact: Hélène CASSOUDESALLE    0556795546    helene.cassoudesalle@chu-bordeaux.fr   
Principal Investigator: Igor SIBON         
Sub-Investigator: Patrick DEHAIL         
Sub-Investigator: Hervé PETIT         
Sub-Investigator: Guillaume VALDENAIRE         
Sub-Investigator: Hugues LOISEAU         
Sponsors and Collaborators
University Hospital, Bordeaux

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03342612     History of Changes
Other Study ID Numbers: CHUBX2016/07
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Brain Injuries, Traumatic
Wounds and Injuries
Brain Injuries
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating