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

Primary Purpose

Mild Traumatic Brain Injury

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Brain Magnetic Resonance Imaging (MRI)
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mild Traumatic Brain Injury

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University Hospital Bordeaux

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brain Magnetic Resonance Imaging (MRI)

Arm Description

Neuroimaging protocol to assess brain changes after minor head trauma and over the time.

Outcomes

Primary Outcome Measures

Fractional anisotropy (FA) measure
Fractional anisotropy (FA) measure by Magnetic Resonance Imaging
Fractional anisotropy (FA) measure by Magnetic Resonance Imaging
Fractional anisotropy (FA) measure by Magnetic Resonance Imaging
Radial diffusivity (RD) measure
Radial diffusivity (RD) measure by Magnetic Resonance Imaging
Radial diffusivity (RD) measure
Radial diffusivity (RD) measure by Magnetic Resonance Imaging
Mean diffusivity (MD) measure
Mean diffusivity (MD) measure by Magnetic Resonance Imaging
Mean diffusivity (MD) measure
Mean diffusivity (MD) measure by Magnetic Resonance Imaging
Axial diffusivity (AD) measure
Axial diffusivity (AD) measure by Magnetic Resonance Imaging
Axial diffusivity (AD) measure
Axial diffusivity (AD) measure by Magnetic Resonance Imaging

Secondary Outcome Measures

Brain areas on MRI sequences
Brain areas on MRI sequences
Brain's white matter injury volume on MRI
Brain's white matter injury volume on MRI
Micro-bleedings measure
Micro-bleedings measure on MRI in the brain parenchyma
Micro-bleedings measure
Micro-bleedings measure on MRI in the brain parenchyma
Blood brain circulation on MRI
Blood brain circulation on MRI
Connectivity modification of on MRI
Connectivity modification of on MRI
Actimetry
Actimetry
Cognitive performances and emotional state by Ecological Momentary Assessment (EMA)
Cognitive performances and emotional state by Ecological Momentary Assessment (EMA)

Full Information

First Posted
August 3, 2017
Last Updated
February 22, 2019
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03342612
Brief Title
Multimodal Neuroimaging Analysis After Mild Traumatic Brain Injury
Acronym
CHANGE-TBI
Official Title
Cerebral Microstructural and Functional Changes After Single and Repeated Mild Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficulties in including Mild Traumatic Brain Injury (mTBI) group despite an extended inclusion period of an additional 12 months
Study Start Date
July 18, 2016 (Actual)
Primary Completion Date
January 29, 2018 (Actual)
Study Completion Date
January 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brain Magnetic Resonance Imaging (MRI)
Arm Type
Experimental
Arm Description
Neuroimaging protocol to assess brain changes after minor head trauma and over the time.
Intervention Type
Procedure
Intervention Name(s)
Brain Magnetic Resonance Imaging (MRI)
Primary Outcome Measure Information:
Title
Fractional anisotropy (FA) measure
Description
Fractional anisotropy (FA) measure by Magnetic Resonance Imaging
Time Frame
Month 0
Title
Fractional anisotropy (FA) measure by Magnetic Resonance Imaging
Description
Fractional anisotropy (FA) measure by Magnetic Resonance Imaging
Time Frame
Month 12
Title
Radial diffusivity (RD) measure
Description
Radial diffusivity (RD) measure by Magnetic Resonance Imaging
Time Frame
Month 0
Title
Radial diffusivity (RD) measure
Description
Radial diffusivity (RD) measure by Magnetic Resonance Imaging
Time Frame
Month 12
Title
Mean diffusivity (MD) measure
Description
Mean diffusivity (MD) measure by Magnetic Resonance Imaging
Time Frame
Month 0
Title
Mean diffusivity (MD) measure
Description
Mean diffusivity (MD) measure by Magnetic Resonance Imaging
Time Frame
Month 12
Title
Axial diffusivity (AD) measure
Description
Axial diffusivity (AD) measure by Magnetic Resonance Imaging
Time Frame
Month 0
Title
Axial diffusivity (AD) measure
Description
Axial diffusivity (AD) measure by Magnetic Resonance Imaging
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Brain areas on MRI sequences
Time Frame
Month 0
Title
Brain areas on MRI sequences
Time Frame
Month 12
Title
Brain's white matter injury volume on MRI
Time Frame
Month 0
Title
Brain's white matter injury volume on MRI
Time Frame
Month 12
Title
Micro-bleedings measure
Description
Micro-bleedings measure on MRI in the brain parenchyma
Time Frame
Month 0
Title
Micro-bleedings measure
Description
Micro-bleedings measure on MRI in the brain parenchyma
Time Frame
Month 12
Title
Blood brain circulation on MRI
Time Frame
Month 0
Title
Blood brain circulation on MRI
Time Frame
Month 12
Title
Connectivity modification of on MRI
Time Frame
Month 0
Title
Connectivity modification of on MRI
Time Frame
Month 12
Title
Actimetry
Time Frame
Month 0
Title
Actimetry
Time Frame
Month 12
Title
Cognitive performances and emotional state by Ecological Momentary Assessment (EMA)
Time Frame
Month 0
Title
Cognitive performances and emotional state by Ecological Momentary Assessment (EMA)
Time Frame
Month 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
University Hospital Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Multimodal Neuroimaging Analysis After Mild Traumatic Brain Injury

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