Multimodal Neuroimaging Analysis After Mild Traumatic Brain Injury

NCT03342612 | Terminated

• 1 other identifier: CHUBX2016/07
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (8)

• Fractional anisotropy (FA) measure

  Fractional anisotropy (FA) measure by Magnetic Resonance Imaging

  Month 0

• Fractional anisotropy (FA) measure by Magnetic Resonance Imaging

  Fractional anisotropy (FA) measure by Magnetic Resonance Imaging

  Month 12

• Radial diffusivity (RD) measure

  Radial diffusivity (RD) measure by Magnetic Resonance Imaging

  Month 0

• Radial diffusivity (RD) measure

  Radial diffusivity (RD) measure by Magnetic Resonance Imaging

  Month 12

• Mean diffusivity (MD) measure

  Mean diffusivity (MD) measure by Magnetic Resonance Imaging

  Month 0

• Mean diffusivity (MD) measure

  Mean diffusivity (MD) measure by Magnetic Resonance Imaging

  Month 12

• Axial diffusivity (AD) measure

  Axial diffusivity (AD) measure by Magnetic Resonance Imaging

  Month 0

• Axial diffusivity (AD) measure

  Axial diffusivity (AD) measure by Magnetic Resonance Imaging

  Month 12

Secondary Outcomes (14)

• Brain areas on MRI sequences

  Month 0

• Brain areas on MRI sequences

  Month 12

• Brain's white matter injury volume on MRI

  Month 0

• Brain's white matter injury volume on MRI

  Month 12

• Micro-bleedings measure

  Month 0

Study Arms (1)

Brain Magnetic Resonance Imaging (MRI)

EXPERIMENTAL

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

Procedure: Brain Magnetic Resonance Imaging (MRI)

Interventions

Brain Magnetic Resonance Imaging (MRI) PROCEDURE

Brain Magnetic Resonance Imaging (MRI)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

University Hospital Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: August 3, 2017
• First Posted: November 17, 2017
• Study Start: July 18, 2016
• Primary Completion: January 29, 2018
• Study Completion: January 29, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)