Clinical trial NCT04730167: The Monaco Initiative for Concussion in Motorsport Pilots
Official title: The Monaco Initiative for Concussion in Motorsport Pilots: Brain Exploration in Retired Motorsport Pilots
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries
Concussion, Brain
Sport Injury
Keywords: Motorsport Pilots
Concussions
Brain trauma
Traumatic brain injuries
MRI
positron emission tomography (PET) scan
Video-oculography
Oculomotor behaviors
Lead sponsor: Association de Recherche Bibliographique pour les Neurosciences
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Princesse Grace
name: University of Cambridge
name: Institut National de Recherche en Informatique et en Automatique
First posted: 2021-01-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retired motorsport pilots coming to the CHPG for a memory assessment or concussion assessment, meeting the study's inclusion criteria, and volunteering to participate.

All assessments and examinations are carried out in routine care, so study essential data will be collected from the patient's medical file (source file): Demographic data, Medical history, Sport practice History of sports, Results of neurological and neuropsychological assessments, Eye-tracking results, MRI results, PET-FDG results.

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).

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.

Eligibility 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.

Primary outcomes:
measure: Patients description
timeFrame: Baseline
measure: Medical history of concussion
timeFrame: Baseline
measure: Presence of Post Concussive Symptoms
timeFrame: Baseline
measure: Neurological evaluation
timeFrame: Baseline
measure: Postural stability
timeFrame: Baseline
measure: MRI scan
timeFrame: Baseline
measure: PET/CT scan - Visual analysis
timeFrame: Baseline
measure: PET/CT scan - Parametric analysis
timeFrame: Baseline
measure: PET/CT scan - other description
timeFrame: Baseline
measure: Global cognitive performance
timeFrame: Baseline
measure: Episodic memory performance
timeFrame: Baseline
measure: Executive performance - Trail Making Test A&B
timeFrame: Baseline
measure: Executive performance - Stroop test
timeFrame: Baseline
measure: Executive performance - B.R.E.F.
timeFrame: Baseline
measure: Executive performance - The Modified Card Sorting Test of Nelson (MCST)
timeFrame: Baseline
measure: Verbal fluency
timeFrame: Baseline
measure: Visuospatial/constructional ability
timeFrame: Baseline
measure: Social cognition and Emotional assessment
timeFrame: Baseline
measure: Selective and sustained attention
timeFrame: Baseline
measure: Storage and handling of information, short term and working memory skill
timeFrame: Baseline
measure: Working memory
timeFrame: Baseline
measure: A sustained attention and working memory test
timeFrame: Baseline
measure: Language
timeFrame: Baseline
measure: Oculomotor paradigms raw performance - Horizontal saccades Latency
timeFrame: Baseline
measure: Oculomotor paradigms raw performance - Horizontal saccades Main velocity
timeFrame: Baseline
measure: Oculomotor paradigms raw performance - Horizontal saccades Gain.
timeFrame: Baseline
measure: Oculomotor paradigms raw performance - Vertical saccades Latency
timeFrame: Baseline
measure: Oculomotor paradigms raw performance - Vertical saccades Main Velocity
timeFrame: Baseline
measure: Oculomotor paradigms raw performance - Vertical saccades Gain
timeFrame: Baseline
measure: Inhibition capacity
timeFrame: Baseline
measure: Internuclear ophthalmoplegia (INO) detection
timeFrame: Baseline
measure: Fixations impairments detection
timeFrame: Baseline
measure: Impairment of smooth pursuit
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Monaco
country: Monaco
facility: Princess Grace Hospital / Department of Nuclear Medicine / Memory Center of the Rainier III Clinical Gerontology Center
Study officials:
affiliation: Department of Nuclear Medicine, Princess Grace Hospital, Monaco.
name: Benoit PAULMIER
role: PRINCIPAL_INVESTIGATOR
References: