The Monaco Initiative for Concussion in Motorsport Pilots
NCT04730167, Completed, Association de Recherche Bibliographique pour les Neurosciences
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Monaco Initiative for Concussion in Motorsport Pilots | ClinicalTrials.gov |
| NCT number | NCT04730167 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 12 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Association de Recherche Bibliographique pour les Neurosciences | ClinicalTrials.gov |
| Conditions | Brain Injuries, Concussion, Brain, Sport Injury | ClinicalTrials.gov |
| Interventions | Neurological and neuropsychological assessments / MRI / PET scan / Video-oculography. | ClinicalTrials.gov |
| First posted | 2021-01-29 | ClinicalTrials.gov |
| Last updated | 2023-10-18 | ClinicalTrials.gov |
Registered outcomes 33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Patients description | Baseline | Describe the profile of included patients | ClinicalTrials.gov |
| Primary | Medical history of concussion | Baseline | Describe the Medical history of concussion of included patients | ClinicalTrials.gov |
| Primary | Presence of Post Concussive Symptoms | Baseline | 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). | ClinicalTrials.gov |
| Primary | Neurological evaluation | Baseline | Assessed by the Neurological exam part of the Sport Concussion Assessment Tool (SCAT), composed of 5 questions. | ClinicalTrials.gov |
| Primary | Postural stability | Baseline | Assessed by Balance Error Scoring System (BESS). Score of 0-60 (lower scores indicate better balance and less errors) | ClinicalTrials.gov |
| Primary | MRI scan | Baseline | MRI data are described according to their nature (lesion / atrophy / sequel / signal anomaly), and classified as present or absent. | ClinicalTrials.gov |
| Primary | PET/CT scan - Visual analysis | Baseline | Description of possible hypometabolic or hypermetabolic areas of the cerebral cortex on the PET / CT images of the subject. | ClinicalTrials.gov |
| Primary | PET/CT scan - Parametric analysis | Baseline | 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) | ClinicalTrials.gov |
| Primary | PET/CT scan - other description | Baseline | Description of any abnormalities found on non-opacified CT slices. | ClinicalTrials.gov |
| Primary | Global cognitive performance | Baseline | 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). | ClinicalTrials.gov |
| Primary | Episodic memory performance | Baseline | 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). | ClinicalTrials.gov |
| Primary | Executive performance - Trail Making Test A&B | Baseline | 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. | ClinicalTrials.gov |
| Primary | Executive performance - Stroop test | Baseline | 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. | ClinicalTrials.gov |
| Primary | Executive performance - B.R.E.F. | Baseline | 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. | ClinicalTrials.gov |
| Primary | Executive performance - The Modified Card Sorting Test of Nelson (MCST) | Baseline | 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. | ClinicalTrials.gov |
| Primary | Verbal fluency | Baseline | 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. | ClinicalTrials.gov |
| Primary | Visuospatial/constructional ability | Baseline | Rey-complex copy figure test is used to evaluate visuospatial/constructional abilities. Performance of each participant is compared to their reference sample. | ClinicalTrials.gov |
| Primary | Social cognition and Emotional assessment | Baseline | 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. | ClinicalTrials.gov |
| Primary | Selective and sustained attention | Baseline | 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. | ClinicalTrials.gov |
| Primary | Storage and handling of information, short term and working memory skill | Baseline | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 11
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Antisaccade Task | Primary outcome | ConductCognition |
| Cancellation Test | Primary outcome | ConductCognition |
| Card Sorting Test (Berg) | Primary outcome | ConductCognition |
| Category Fluency | Primary outcome | ConductCognition |
| Digit Span Test | Primary outcome | ConductCognition |
| Paced Visual Serial Addition Test | Primary outcome | ConductCognition |
| Selective Reminding Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)