Pilot Study Evaluating brainQuant's Ability to Detect Alterations in White Matter in Diffusion MR… (NCT07302503) | Clinical Trial Compass
RecruitingNot Applicable
Pilot Study Evaluating brainQuant's Ability to Detect Alterations in White Matter in Diffusion MRI, Indicative of Post-traumatic Lesions
France80 participantsStarted 2024-09-10
Plain-language summary
Chronic traumatic encephalopathy (CTE) is a neurodegenerative disease described in boxing, but also in contact sports such as American football.
Soccer, due to repeated headers, could also be associated, albeit to a lesser degree, with the development of this type of pathology.
Indeed, it has been shown that playing soccer can be accompanied by cognitive impairments, and neurodegenerative brain abnormalities have been described in neuropathology studies of former professional soccer players. Subradiological brain abnormalities have been found in multimodal MRI in various sports. Similarly, a decrease in cognitive performance has been described.
The discovery of this type of anomaly in a population of professional footballers nearing the end of their careers could lead to:
* The implementation of appropriate monitoring for professional footballers through early detection of lesions via MRI and cognitive disorders
* The implementation of preventative measures for professional footballers, but also for amateur footballers from a very young age.
Who can participate
Age range
32 Years – 60 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male subject
* Aged 32 to 60 years inclusive
* Professional footballer nearing the end of their career or recently retired, or subject who has never regularly participated in sports that expose them to head trauma (particularly rugby, basketball, handball, American football, hockey, combat sports, etc.)
Exclusion Criteria:
\- Subject who expressed their opposition to participating in the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes found in MRI diffusion tensor imaging of professional football players