An observational study in Brain Injuries, Concussion, Brain and Sport Injury, sponsored by Association de Recherche Bibliographique pour les Neurosciences. Completed at 1 site in Monaco. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by Association de Recherche Bibliographique pour les Neurosciences · Observational
The study aims:
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.
637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.
This study's enrollment of 12 is below the median of 149 across 166 observational studies indexed under Brain Concussion.
Browse Brain Concussion studies →Association de Recherche Bibliographique pour les Neurosciences is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Compared within Brain Concussion, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Brain Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Concussion assessment
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).
Patients description
Describe the profile of included patients
Time frame: Baseline
Medical history of concussion
Describe the Medical history of concussion of included patients
Time frame: Baseline
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).
Time frame: Baseline
Neurological evaluation
Assessed by the Neurological exam part of the Sport Concussion Assessment Tool (SCAT), composed of 5 questions.
Time frame: Baseline
Postural stability
Assessed by Balance Error Scoring System (BESS). Score of 0-60 (lower scores indicate better balance and less errors)
Time frame: Baseline
MRI scan
MRI data are described according to their nature (lesion / atrophy / sequel / signal anomaly), and classified as present or absent.
Time frame: Baseline
PET/CT scan - Visual analysis
Description of possible hypometabolic or hypermetabolic areas of the cerebral cortex on the PET / CT images of the subject.
Time frame: Baseline
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)
Time frame: Baseline
PET/CT scan - other description
Description of any abnormalities found on non-opacified CT slices.
Time frame: Baseline
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).
Time frame: Baseline
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).
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
Language
The "Dénomination d'Objet 80" (DO 80), is an image naming task in order to assess language and visual gnosias.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
Plan to share: No
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Ran from Oct 2021 to primary completion in Aug 2023, 22 months.
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Association de Recherche Bibliographique pour les Neurosciences