NCT03342612: CHANGE-TBI

Multimodal Neuroimaging Analysis After Mild Traumatic Brain Injury

Terminated NA Last updated 26 February 2019

What this trial tests

NA trial testing Brain Magnetic Resonance Imaging (MRI) in Mild Traumatic Brain Injury in 41 participants. Terminated before completion.

Timeline

18 July 2016

Primary endpoint
29 January 2018

29 January 2018

Quick facts

Lead sponsor	University Hospital, Bordeaux
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	41
Start date	18 July 2016
Primary completion	29 January 2018
Estimated completion	29 January 2018
Sites	1 location across France

Drugs / interventions tested

• Brain Magnetic Resonance Imaging (MRI)

Conditions studied

• Mild Traumatic Brain Injury — all drugs for Mild Traumatic Brain Injury →

Sponsor

University Hospital, Bordeaux

Who can join

Adults 18 to 30, male only, with Mild Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.