Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT04730167
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2021-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Monaco Initiative for Concussion in Motorsport Pilots
Sponsor:
Association de Recherche Bibliographique pour les Neurosciences
Organization:
Study Overview
Official Title:
The Monaco Initiative for Concussion in Motorsport Pilots: Brain Exploration in Retired Motorsport Pilots
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims:
* to observe a population particularly exposed by the past to brain trauma and concussion: Motorsport Pilots who are retired from a professional practice of motor sport;
* to report results of their neuro-cognitive evaluations,
* to determine if specific profiles emerge.
* to evaluate potential consequences of these traumas' history at a cerebral, physical and psychological level.
* to evaluate the contribution of the various examinations performed as part of a concussion assessment in routine care (eye-tracking, brain imaging, Neuropsychological Assessment).
* to observe a population particularly exposed by the past to brain trauma and concussion: Motorsport Pilots who are retired from a professional practice of motor sport;
* to report results of their neuro-cognitive evaluations,
* to determine if specific profiles emerge.
* to evaluate potential consequences of these traumas' history at a cerebral, physical and psychological level.
* to evaluate the contribution of the various examinations performed as part of a concussion assessment in routine care (eye-tracking, brain imaging, Neuropsychological Assessment).
Detailed Description:
The Memory Center of the Rainier III Center and The Department of Nuclear Medicine of the Princess Grace Hospital are particularly aware of evaluation, management and monitoring of patients who have suffered brain trauma, or concussions, and the study of possible long-term consequences.
They regularly receive patients, referred by neurologists or spontaneously coming for consultation, for whom the carrying out of a complete in-depth evaluation is recommended, because of their medical history and their personal history.
In partnership with the "Fédération Internationale de l'Automobile" (FIA) and the "Automobile Club of Monaco" (ACM), the Princess Grace Hospital team hopes ultimately to set up a screening campaign for traumatic brain injuries among a particularly exposed population: motorsports people.
In this context, inspired by the work carried out by the Cambridge University team (the Rescue Racer Study) and the FIA recommendations, the Sponsor wishes to carry out an observational study with retired motor sportspeople.
The objectives are to study a population particularly exposed by the past to brain trauma and concussion (who is retired from a professional practice of motor sport), to report results of their neuro-cognitive evaluations, and to determine if specific profiles emerge, to evaluate potential consequences of these traumas' history at a cerebral, physical and psychological level.
They regularly receive patients, referred by neurologists or spontaneously coming for consultation, for whom the carrying out of a complete in-depth evaluation is recommended, because of their medical history and their personal history.
In partnership with the "Fédération Internationale de l'Automobile" (FIA) and the "Automobile Club of Monaco" (ACM), the Princess Grace Hospital team hopes ultimately to set up a screening campaign for traumatic brain injuries among a particularly exposed population: motorsports people.
In this context, inspired by the work carried out by the Cambridge University team (the Rescue Racer Study) and the FIA recommendations, the Sponsor wishes to carry out an observational study with retired motor sportspeople.
The objectives are to study a population particularly exposed by the past to brain trauma and concussion (who is retired from a professional practice of motor sport), to report results of their neuro-cognitive evaluations, and to determine if specific profiles emerge, to evaluate potential consequences of these traumas' history at a cerebral, physical and psychological level.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: