Brain InjuriesNCT04730167
The Monaco Initiative for Concussion in Motorsport Pilots
An observational study of Brain Injuries and Concussion, Brain, run by Association de Recherche Bibliographique pour les Neurosciences at 1 site in Monaco.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Concussion, Brain, Sport Injury
- What is being tested?
- Neurological and neuropsychological assessments / MRI / PET scan / Video-oculography.
- How many people
- 12 participants
- Where
- 1 siteMonaco
- Study dates
- 5 Oct 2021to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
- 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.
Trial locations and contacts
1 site in 1 country.
Monaco1 site
Princess Grace Hospital / Department of Nuclear Medicine / Memory Center of the Rainier III Clinical Gerontology Center
Monaco, 98000
About this study
Official title: The Monaco Initiative for Concussion in Motorsport Pilots: Brain Exploration in Retired Motorsport Pilots
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).
Read the 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.
- Conditions
- Brain Injuries, Concussion, Brain, Sport Injury
- Being tested
- Neurological and neuropsychological assessments / MRI / PET scan / Video-oculography.
- Keywords
- Motorsport Pilots, Concussions, Brain trauma, Traumatic brain injuries, MRI, positron emission tomography (PET) scan, Video-oculography, Oculomotor behaviors
- Medical subject headings
- Brain Injuries, Brain Concussion, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological and neuropsychological assessments / MRI / PET scan / Video-oculography.Other
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).
| Study group | Role | What they receive |
|---|---|---|
| Retired Motorsport Pilots | Concussion assessment Receives: Other: Neurological and neuropsychological assessments / MRI / PET scan / Video-oculography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients description
Describe the profile of included patients
Measured: Baseline
Medical history of concussion
Describe the Medical history of concussion of included patients
Measured: 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).
Measured: Baseline
Neurological evaluation
Assessed by the Neurological exam part of the Sport Concussion Assessment Tool (SCAT), composed of 5 questions.
Measured: Baseline
Postural stability
Assessed by Balance Error Scoring System (BESS). Score of 0-60 (lower scores indicate better balance and less errors)
Measured: Baseline
MRI scan
MRI data are described according to their nature (lesion / atrophy / sequel / signal anomaly), and classified as present or absent.
Measured: 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.
Measured: 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)
Measured: Baseline
PET/CT scan - other description
Description of any abnormalities found on non-opacified CT slices.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Language
The "Dénomination d'Objet 80" (DO 80), is an image naming task in order to assess language and visual gnosias.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start5 Oct 2021
- Primary completion5 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association de Recherche Bibliographique pour les Neurosciences
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Princesse Grace, University of Cambridge, Institut National de Recherche en Informatique et en Automatique
- Responsible party
- Sponsor
- Investigators
- Benoit PAULMIER, Principal investigator, Department of Nuclear Medicine, Princess Grace Hospital, Monaco.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730167
- Sponsor's protocol ID
- MIMP
- Status last verified
- May 2023
- First submitted
- 19 Jan 2021
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Monaco Initiative for Concussion in Motorsport Pilots: Brain Exploration in Retired Motorsport Pilots
- ClinicalTrials.gov ID
- NCT04730167
- Acronym / sponsor ID
- MIMP
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Association de Recherche Bibliographique pour les NeurosciencesUniversity, hospital or other
- Collaborators
- Centre Hospitalier Princesse Grace, University of Cambridge, Institut National de Recherche en Informatique et en Automatique
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retired Motorsport Pilots | – | Other: Neurological and neuropsychological assessments / MRI / PET scan / Video-oculography.Concussion assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Retired Motorsport Pilots |
Primary outcome
Patients description
Time frame: Baseline
Describe the profile of included patients
Medical history of concussion
Time frame: Baseline
Describe the Medical history of concussion of included patients
Presence of Post Concussive Symptoms
Time frame: 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).
Neurological evaluation
Time frame: Baseline
Assessed by the Neurological exam part of the Sport Concussion Assessment Tool (SCAT), composed of 5 questions.
Postural stability
Time frame: Baseline
Assessed by Balance Error Scoring System (BESS). Score of 0-60 (lower scores indicate better balance and less errors)
MRI scan
Time frame: Baseline
MRI data are described according to their nature (lesion / atrophy / sequel / signal anomaly), and classified as present or absent.
PET/CT scan - Visual analysis
Time frame: Baseline
Description of possible hypometabolic or hypermetabolic areas of the cerebral cortex on the PET / CT images of the subject.
PET/CT scan - Parametric analysis
Time frame: 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)
PET/CT scan - other description
Time frame: Baseline
Description of any abnormalities found on non-opacified CT slices.
Global cognitive performance
Time frame: 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).
Episodic memory performance
Time frame: 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).
Executive performance - Trail Making Test A&B
Time frame: 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.
Executive performance - Stroop test
Time frame: 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.
Executive performance - B.R.E.F.
Time frame: 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.
Executive performance - The Modified Card Sorting Test of Nelson (MCST)
Time frame: 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.
Verbal fluency
Time frame: 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.
Visuospatial/constructional ability
Time frame: Baseline
Rey-complex copy figure test is used to evaluate visuospatial/constructional abilities. Performance of each participant is compared to their reference sample.
Social cognition and Emotional assessment
Time frame: 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.
Selective and sustained attention
Time frame: 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.
Storage and handling of information, short term and working memory skill
Time frame: 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.
Working memory
Time frame: Baseline
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.
A sustained attention and working memory test
Time frame: Baseline
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.
Language
Time frame: Baseline
The "Dénomination d'Objet 80" (DO 80), is an image naming task in order to assess language and visual gnosias.
Oculomotor paradigms raw performance - Horizontal saccades Latency
Time frame: Baseline
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.
Oculomotor paradigms raw performance - Horizontal saccades Main velocity
Time frame: Baseline
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.
Oculomotor paradigms raw performance - Horizontal saccades Gain.
Time frame: Baseline
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.
Oculomotor paradigms raw performance - Vertical saccades Latency
Time frame: Baseline
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.
Oculomotor paradigms raw performance - Vertical saccades Main Velocity
Time frame: Baseline
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.
Oculomotor paradigms raw performance - Vertical saccades Gain
Time frame: Baseline
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.
Inhibition capacity
Time frame: Baseline
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.
Internuclear ophthalmoplegia (INO) detection
Time frame: Baseline
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.
Fixations impairments detection
Time frame: Baseline
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.
Impairment of smooth pursuit
Time frame: Baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Brain Injuries
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit PAULMIER principal investigator
Department of Nuclear Medicine, Princess Grace Hospital, Monaco.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries and Concussion, Brain, run by Association de Recherche Bibliographique pour les Neurosciences at 1 site in Monaco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients description (time frame: Baseline). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.