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Trial record 46 of 313 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

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

August 3, 2017
November 17, 2017
November 17, 2017
July 18, 2016
July 18, 2019   (Final data collection date for primary outcome measure)
  • Fractional anisotropy (FA) measure [ Time Frame: Month 0 ]
    Fractional anisotropy (FA) measure by Magnetic Resonance Imaging
  • Fractional anisotropy (FA) measure by Magnetic Resonance Imaging [ Time Frame: Month 12 ]
    Fractional anisotropy (FA) measure by Magnetic Resonance Imaging
  • Radial diffusivity (RD) measure [ Time Frame: Month 0 ]
    Radial diffusivity (RD) measure by Magnetic Resonance Imaging
  • Radial diffusivity (RD) measure [ Time Frame: Month 12 ]
    Radial diffusivity (RD) measure by Magnetic Resonance Imaging
  • Mean diffusivity (MD) measure [ Time Frame: Month 0 ]
    Mean diffusivity (MD) measure by Magnetic Resonance Imaging
  • Mean diffusivity (MD) measure [ Time Frame: Month 12 ]
    Mean diffusivity (MD) measure by Magnetic Resonance Imaging
  • Axial diffusivity (AD) measure [ Time Frame: Month 0 ]
    Axial diffusivity (AD) measure by Magnetic Resonance Imaging
  • Axial diffusivity (AD) measure [ Time Frame: Month 12 ]
    Axial diffusivity (AD) measure by Magnetic Resonance Imaging
Same as current
No Changes Posted
  • Brain areas on MRI sequences [ Time Frame: Month 0 ]
  • Brain areas on MRI sequences [ Time Frame: Month 12 ]
  • Brain's white matter injury volume on MRI [ Time Frame: Month 0 ]
  • Brain's white matter injury volume on MRI [ Time Frame: Month 12 ]
  • Micro-bleedings measure [ Time Frame: Month 0 ]
    Micro-bleedings measure on MRI in the brain parenchyma
  • Micro-bleedings measure [ Time Frame: Month 12 ]
    Micro-bleedings measure on MRI in the brain parenchyma
  • Blood brain circulation on MRI [ Time Frame: Month 0 ]
  • Blood brain circulation on MRI [ Time Frame: Month 12 ]
  • Connectivity modification of on MRI [ Time Frame: Month 0 ]
  • Connectivity modification of on MRI [ Time Frame: Month 12 ]
  • Actimetry [ Time Frame: Month 0 ]
  • Actimetry [ Time Frame: Month 12 ]
  • Cognitive performances and emotional state by Ecological Momentary Assessment (EMA) [ Time Frame: Month 0 ]
  • Cognitive performances and emotional state by Ecological Momentary Assessment (EMA) [ Time Frame: Month 12 ]
Same as current
Not Provided
Not Provided
 
Multimodal Neuroimaging Analysis After Mild Traumatic Brain Injury
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.

Not Provided
Interventional
Not Applicable
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
Mild Traumatic Brain Injury
Procedure: Brain Magnetic Resonance Imaging (MRI)
Experimental: Brain Magnetic Resonance Imaging (MRI)
Neuroimaging protocol to assess brain changes after minor head trauma and over the time.
Intervention: Procedure: Brain Magnetic Resonance Imaging (MRI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Same as current
July 18, 2019
July 18, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 25 Years   (Adult)
Yes
Contact: Igor SIBON 0556795520 igor.sibon@chu-bordeaux.fr
Contact: Caroline BUISSON 0556795540 caroline.buisson@chu-bordeaux.fr
France
 
 
NCT03342612
CHUBX2016/07
No
Not Provided
Plan to Share IPD: No
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Not Provided
University Hospital, Bordeaux
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP