The Monaco Initiative for Concussion in Motorsport Pilots

NCT ID: NCT04730167

Last Updated: 2023-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-05

Study Completion Date

2023-08-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Brain Injuries Concussion, Brain Sport Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Retired Motorsport Pilots

Concussion assessment

Neurological and neuropsychological assessments / MRI / PET scan / Video-oculography.

Intervention Type OTHER

Essential data for this study are those collected during the concussion assessment, carried out as part of routine care at Princess Grace Hospital (medical background; history of sports practice and history of concussions; data extracted from clinical and neuropsychological evaluations, from imaging exams (MRI and PET-Scan) and from eye-tracking evaluation).

Interventions

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Neurological and neuropsychological assessments / MRI / PET scan / Video-oculography.

Essential data for this study are those collected during the concussion assessment, carried out as part of routine care at Princess Grace Hospital (medical background; history of sports practice and history of concussions; data extracted from clinical and neuropsychological evaluations, from imaging exams (MRI and PET-Scan) and from eye-tracking evaluation).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men or women.
* Aged 18 years and older.
* Retired motor sport pilot (Formula 1 or rally).
* Expressing a cognitive, memory, somatic, emotional complaint, sleep disorders or a concern following the practice of Motorsport, that motivate carrying out of a memory assessment or a concussion assessment in routine care.
* Who are willing to participate in the study and give their written informed consent.
* Covered by a health insurance system.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Princesse Grace

OTHER

Sponsor Role collaborator

University of Cambridge

OTHER

Sponsor Role collaborator

Institut National de Recherche en Informatique et en Automatique

OTHER

Sponsor Role collaborator

Association de Recherche Bibliographique pour les Neurosciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benoit PAULMIER

Role: PRINCIPAL_INVESTIGATOR

Department of Nuclear Medicine, Princess Grace Hospital, Monaco.

Locations

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Princess Grace Hospital / Department of Nuclear Medicine / Memory Center of the Rainier III Clinical Gerontology Center

Monaco, , Monaco

Site Status

Countries

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Monaco

Other Identifiers

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MIMP

Identifier Type: -

Identifier Source: org_study_id

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