The Monaco Initiative for Concussion in Motorsport Pilots

Brain Injuries Clinical Trial

Official title:

The Monaco Initiative for Concussion in Motorsport Pilots: Brain Exploration in Retired Motorsport Pilots

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04730167
• Other study ID #: MIMP
• Status: Completed
• Start date: October 5, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: May 2023
• Source: Association de Recherche Bibliographique pour les Neurosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 31, 2023
• Est. primary completion date: August 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Athletic Injuries
• Brain Concussion
• Brain Injuries
• Concussion, Brain
• Sport Injury
• Wounds and Injuries

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Monaco	Princess Grace Hospital / Department of Nuclear Medicine / Memory Center of the Rainier III Clinical Gerontology Center	Monaco

Sponsors (4)

Lead Sponsor	Collaborator
Association de Recherche Bibliographique pour les Neurosciences	Centre Hospitalier Princesse Grace, Institut National de Recherche en Informatique et en Automatique, University of Cambridge

Country where clinical trial is conducted

Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients description	Describe the profile of included patients	Baseline
Primary	Medical history of concussion	Describe the Medical history of concussion of included patients	Baseline
Primary	Presence of Post Concussive Symptoms	Assessed by the Symptoms Scale of the Sport Concussion Assessment Tool (SCAT), composed of 22 post concussive symptom items graded on a scale from 0 (no symptoms) to 6 (severe symptoms), summed to form a symptom severity score (range 0-132).	Baseline
Primary	Neurological evaluation	Assessed by the Neurological exam part of the Sport Concussion Assessment Tool (SCAT), composed of 5 questions.	Baseline
Primary	Postural stability	Assessed by Balance Error Scoring System (BESS). Score of 0-60 (lower scores indicate better balance and less errors)	Baseline
Primary	MRI scan	MRI data are described according to their nature (lesion / atrophy / sequel / signal anomaly), and classified as present or absent.	Baseline
Primary	PET/CT scan - Visual analysis	Description of possible hypometabolic or hypermetabolic areas of the cerebral cortex on the PET / CT images of the subject.	Baseline
Primary	PET/CT scan - Parametric analysis	The uptake values of [18F]-2-fluoro-2-deoxy-D-glucose (18-FDG) (average uptake and standard deviation) of several target regions of the subject's cerebral cortex will be entered in comparison with an age-matched database developed in the Scenium software from Siemens Medical Solutions USA® (software version VB30A)	Baseline
Primary	PET/CT scan - other description	Description of any abnormalities found on non-opacified CT slices.	Baseline
Primary	Global cognitive performance	MONTREAL COGNITIVE ASSESSMENT (MOCA) is used to evaluate Global cognitive performance. MOCA is a 30-question general cognitive function assessment. The maximum score is 30. Performance of each participant is compared to their reference sample (depending on age, sex and level study).	Baseline
Primary	Episodic memory performance	The Grober and Buschke Free and Cued recall (16 items) or the Selective Reminding Test are used to evaluate Episodic memory. Performances of each participant are compared to their reference sample (depending on age, sex and level study).	Baseline
Primary	Executive performance - Trail Making Test A&B	Trail Making Test (T.M.T) A&B is used to evaluate executive performance. The task requires a subject to connect a sequence of 25 consecutive targets on a sheet of paper, in the shortest time possible without lifting the pen from the paper. Time performances of each participant are compared to their reference sample.	Baseline
Primary	Executive performance - Stroop test	Stroop test (GREFFEX) is used to evaluate executive performance and more specifically inhibition. The time to complete each condition (in seconds) is recorded, as well as the number of uncorrected and corrected errors. Stroop task performances of each participant are compared to their reference sample.	Baseline
Primary	Executive performance - B.R.E.F.	The "Batterie rapide d'évaluation frontale" (B.R.E.F.), or Frontal Assessment Battery at Bedside (F.A.B.), is used to determine the presence or not of a cognitive and behavioral dysexecution syndrom. The maximum score is 18. Performances of each participant are compared to their reference sample.	Baseline
Primary	Executive performance - The Modified Card Sorting Test of Nelson (MCST)	The Modified Card Sorting Test of Nelson (MCST) is used to evaluate executive function in patients with focal, traumatic and degenerative brain diseases. Performance on the MCST is scored by computing the number of categories achieved by a participant, and the number of perseverative errors. Performance of each participant are compared to their reference sample.	Baseline
Primary	Verbal fluency	Verbal fluency test is a short test of verbal functioning. It consists of two tasks: category fluency and letter fluency. Participant is given 1 minute to produce as many unique words as possible within a semantic category (category fluency) or starting with a given letter (letter fluency). The participant's score in each task is the number of unique correct words. Performances of each participant are compared to their reference sample.	Baseline
Primary	Visuospatial/constructional ability	Rey-complex copy figure test is used to evaluate visuospatial/constructional abilities. Performance of each participant is compared to their reference sample.	Baseline
Primary	Social cognition and Emotional assessment	The Mini-sea is used to evaluate Social cognition. Evaluation criteria: Scores to Ekman Faces task (1976): total score / 35 and sub-scores / 5. Performances of each participant are compared to their reference sample.	Baseline
Primary	Selective and sustained attention	The d2 Test of Attention is a cancellation test of attention and concentration that measures selective and sustained attention. Participant cross out any letter "d" with two marks around above it or below it in any order. The surrounding distractors are usually similar to the target stimulus, for example a "p" with two marks or a "d" with one or three marks (Ability to concentrate, Processing speed, Percentage of errors). The quotation provides values for the three main indices. Performances of each participant are compared to their reference sample.	Baseline
Primary	Storage and handling of information, short term and working memory skill	The Digit span and spatial span tasks (Empans) assess the storage and handling of information, short term and working memory skill. Participant reads a sequence of numbers and is asked to repeat the same sequence back to the examiner in order (forward span) or in reverse order (backward span). As well for spatial span task. Four scores are obtained (forward and backward verbal scores, forward and backward visuospatial scores). Performances of each participant are compared to their reference sample.	Baseline
Primary	Working memory	Baddeley's dual task assess the ability to coordinate two tasks simultaneously divided attention ability. The score of each participant are compared to their reference sample.	Baseline
Primary	A sustained attention and working memory test	PASAT (Paced Auditory Serial Addition Test) is a sustained attention and working memory test. The results are expressed as a score of 60 points. Performances of each participant are compared to their reference sample.	Baseline
Primary	Language	The "Dénomination d'Objet 80" (DO 80), is an image naming task in order to assess language and visual gnosias.	Baseline
Primary	Oculomotor paradigms raw performance - Horizontal saccades Latency	This concerns saccades Latency (in ms) during horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device.; For each subject value were judged abnormal if they differed by >1.65 Standard Deviation (SD) compared to their reference sample.	Baseline
Primary	Oculomotor paradigms raw performance - Horizontal saccades Main velocity	This concerns saccades Main velocity (in °/sec) during horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device.; For each subject value were judged abnormal if they differed by >1.65 Standard Deviation (SD) compared to their reference sample.	Baseline
Primary	Oculomotor paradigms raw performance - Horizontal saccades Gain.	This concerns saccades Gain (gaze accuracy) during horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device.; For each subject value were judged abnormal if they differed by >1.65 Standard Deviation (SD) compared to their reference sample.	Baseline
Primary	Oculomotor paradigms raw performance - Vertical saccades Latency	This concerns saccades Latency (in ms) during vertical paradigms. Eye movements were recorded and analyzed with an eye-tracking device.; For each subject value were judged abnormal if they differed by >1.65 SD compared to their reference sample.	Baseline
Primary	Oculomotor paradigms raw performance - Vertical saccades Main Velocity	This concerns saccades Main velocity (in °/sec) during vertical paradigms. Eye movements were recorded and analyzed with an eye-tracking device.; For each subject value were judged abnormal if they differed by >1.65 SD compared to their reference sample.	Baseline
Primary	Oculomotor paradigms raw performance - Vertical saccades Gain	This concerns saccades Gain (gaze accuracy) during vertical paradigms. Eye movements were recorded and analyzed with an eye-tracking device.; For each subject value were judged abnormal if they differed by >1.65 SD compared to their reference sample.	Baseline
Primary	Inhibition capacity	Measure of inhibition capacity performance during an "antisaccades" paradigm. Eye movements were recorded and analyzed with an eye-tracking device. Evaluation criteria: percentage of errors. For each subject value were judged abnormal if they differed by >1.65 SD compared to their reference sample.	Baseline
Primary	Internuclear ophthalmoplegia (INO) detection	Highlight presence/absence of INO. Eye movements were recorded and analyzed with an eye-tracking device. Evaluation criteria: INO is present if calculated ratio of abducting to adducting eye movement (both mean and peak velocity) is >1.	Baseline
Primary	Fixations impairments detection	Highlight presence/absence of Fixations impairments. Eye movements were recorded and analyzed with an eye-tracking device. Evaluation criteria: presence/absence/frequency of square wave-jerks, nystagmus, flutters.	Baseline
Primary	Impairment of smooth pursuit	Highlight Impairment of horizontal and vertical smooth pursuit. Eye movements were recorded and analyzed with an eye-tracking device. Evaluation criteria: presence/absence of saccade and perturbation.	Baseline