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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2021-01-19', 'studyFirstSubmitQcDate': '2021-01-25', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients description', 'timeFrame': 'Baseline', 'description': 'Describe the profile of included patients'}, {'measure': 'Medical history of concussion', 'timeFrame': 'Baseline', 'description': 'Describe the Medical history of concussion of included patients'}, {'measure': 'Presence of Post Concussive Symptoms', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Neurological evaluation', 'timeFrame': 'Baseline', 'description': 'Assessed by the Neurological exam part of the Sport Concussion Assessment Tool (SCAT), composed of 5 questions.'}, {'measure': 'Postural stability', 'timeFrame': 'Baseline', 'description': 'Assessed by Balance Error Scoring System (BESS). Score of 0-60 (lower scores indicate better balance and less errors)'}, {'measure': 'MRI scan', 'timeFrame': 'Baseline', 'description': 'MRI data are described according to their nature (lesion / atrophy / sequel / signal anomaly), and classified as present or absent.'}, {'measure': 'PET/CT scan - Visual analysis', 'timeFrame': 'Baseline', 'description': 'Description of possible hypometabolic or hypermetabolic areas of the cerebral cortex on the PET / CT images of the subject.'}, {'measure': 'PET/CT scan - Parametric analysis', 'timeFrame': 'Baseline', 'description': "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)"}, {'measure': 'PET/CT scan - other description', 'timeFrame': 'Baseline', 'description': 'Description of any abnormalities found on non-opacified CT slices.'}, {'measure': 'Global cognitive performance', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Episodic memory performance', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Executive performance - Trail Making Test A&B', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Executive performance - Stroop test', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Executive performance - B.R.E.F.', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Executive performance - The Modified Card Sorting Test of Nelson (MCST)', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Verbal fluency', 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'Visuospatial/constructional ability', 'timeFrame': 'Baseline', 'description': 'Rey-complex copy figure test is used to evaluate visuospatial/constructional abilities. Performance of each participant is compared to their reference sample.'}, {'measure': 'Social cognition and Emotional assessment', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Selective and sustained attention', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Storage and handling of information, short term and working memory skill', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Working memory', 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'A sustained attention and working memory test', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Language', 'timeFrame': 'Baseline', 'description': 'The "Dénomination d\'Objet 80" (DO 80), is an image naming task in order to assess language and visual gnosias.'}, {'measure': 'Oculomotor paradigms raw performance - Horizontal saccades Latency', 'timeFrame': 'Baseline', 'description': 'This concerns saccades Latency (in ms) during horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device.\n\nFor each subject value were judged abnormal if they differed by \\>1.65 Standard Deviation (SD) compared to their reference sample.'}, {'measure': 'Oculomotor paradigms raw performance - Horizontal saccades Main velocity', 'timeFrame': 'Baseline', 'description': 'This concerns saccades Main velocity (in °/sec) during horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device.\n\nFor each subject value were judged abnormal if they differed by \\>1.65 Standard Deviation (SD) compared to their reference sample.'}, {'measure': 'Oculomotor paradigms raw performance - Horizontal saccades Gain.', 'timeFrame': 'Baseline', 'description': 'This concerns saccades Gain (gaze accuracy) during horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device.\n\nFor each subject value were judged abnormal if they differed by \\>1.65 Standard Deviation (SD) compared to their reference sample.'}, {'measure': 'Oculomotor paradigms raw performance - Vertical saccades Latency', 'timeFrame': 'Baseline', 'description': 'This concerns saccades Latency (in ms) during vertical paradigms. Eye movements were recorded and analyzed with an eye-tracking device.\n\nFor each subject value were judged abnormal if they differed by \\>1.65 SD compared to their reference sample.'}, {'measure': 'Oculomotor paradigms raw performance - Vertical saccades Main Velocity', 'timeFrame': 'Baseline', 'description': 'This concerns saccades Main velocity (in °/sec) during vertical paradigms. Eye movements were recorded and analyzed with an eye-tracking device.\n\nFor each subject value were judged abnormal if they differed by \\>1.65 SD compared to their reference sample.'}, {'measure': 'Oculomotor paradigms raw performance - Vertical saccades Gain', 'timeFrame': 'Baseline', 'description': 'This concerns saccades Gain (gaze accuracy) during vertical paradigms. Eye movements were recorded and analyzed with an eye-tracking device.\n\nFor each subject value were judged abnormal if they differed by \\>1.65 SD compared to their reference sample.'}, {'measure': 'Inhibition capacity', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Internuclear ophthalmoplegia (INO) detection', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Fixations impairments detection', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Impairment of smooth pursuit', 'timeFrame': 'Baseline', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Motorsport Pilots', 'Concussions', 'Brain trauma', 'Traumatic brain injuries', 'MRI', 'positron emission tomography (PET) scan', 'Video-oculography', 'Oculomotor behaviors'], 'conditions': ['Brain Injuries', 'Concussion, Brain', 'Sport Injury']}, 'descriptionModule': {'briefSummary': "The study aims:\n\n* 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;\n* to report results of their neuro-cognitive evaluations,\n* to determine if specific profiles emerge.\n* to evaluate potential consequences of these traumas' history at a cerebral, physical and psychological level.\n* to evaluate the contribution of the various examinations performed as part of a concussion assessment in routine care (eye-tracking, brain imaging, Neuropsychological Assessment).", 'detailedDescription': '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.\n\nThey 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.\n\nIn 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.\n\nIn 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Retired motorsport pilots coming to the CHPG for a memory assessment or concussion assessment, meeting the study's inclusion criteria, and volunteering to participate.\n\nAll 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.", 'healthyVolunteers': False, 'eligibilityCriteria': '* Men or women.\n* Aged 18 years and older.\n* Retired motor sport pilot (Formula 1 or rally).\n* 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.\n* Who are willing to participate in the study and give their written informed consent.\n* Covered by a health insurance system.'}, 'identificationModule': {'nctId': 'NCT04730167', 'briefTitle': 'The Monaco Initiative for Concussion in Motorsport Pilots', 'organization': {'class': 'OTHER', 'fullName': 'Association de Recherche Bibliographique pour les Neurosciences'}, 'officialTitle': 'The Monaco Initiative for Concussion in Motorsport Pilots: Brain Exploration in Retired Motorsport Pilots', 'orgStudyIdInfo': {'id': 'MIMP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retired Motorsport Pilots', 'description': 'Concussion assessment', 'interventionNames': ['Other: Neurological and neuropsychological assessments / MRI / PET scan / Video-oculography.']}], 'interventions': [{'name': 'Neurological and neuropsychological assessments / MRI / PET scan / Video-oculography.', 'type': 'OTHER', 'description': '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).', 'armGroupLabels': ['Retired Motorsport Pilots']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98000', 'city': 'Monaco', 'country': 'Monaco', 'facility': 'Princess Grace Hospital / Department of Nuclear Medicine / Memory Center of the Rainier III Clinical Gerontology Center', 'geoPoint': {'lat': 43.73718, 'lon': 7.42145}}], 'overallOfficials': [{'name': 'Benoit PAULMIER', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nuclear Medicine, Princess Grace Hospital, Monaco.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association de Recherche Bibliographique pour les Neurosciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Princesse Grace', 'class': 'OTHER'}, {'name': 'University of Cambridge', 'class': 'OTHER'}, {'name': 'Institut National de Recherche en Informatique et en Automatique', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}