Parkinson Disease, IdiopathicNCT04731246
Video-oculography and Parkinson's Disease
A study testing Video-oculography / Neuropsychological evaluations in people with Parkinson Disease, Idiopathic, run by Association de Recherche Bibliographique pour les Neurosciences at 1 site in Monaco.
Trial summary
This study aims to study, in patient with Parkinson's disease, mild to moderate stage (according to Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease, Postuma et al., 2015): the evolution of oculomotricity markers over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Idiopathic
- What is being tested?
- Video-oculography / Neuropsychological evaluations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMonaco
- Study dates
- 7 Jul 2021to Jan 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Male or Female;
- Clinically defined idiopathic Parkinson's Disease (PD);
- Brain MRI performed in routine care in the 12 months preceding inclusion;
- Cerebral DaTSCAN or cerebral PET with F-DOPA, performed as routine care before inclusion (no time limit), confirming presynaptic dopaminergic denervation;
- Hoehn \& Yahr score: 1 to 3;
- Normal clinical examination of oculomotricity (slight impairment of smooth pursuit accepted);
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- Neuro-cognitive disorders: absent or minor (according to DSM5);
- Sufficient written and oral expression in French;
- Covered by a health insurance system;
- Written informed consent signed by the patient;
- Presence of a caregiver.
Who cannot join
- Psychiatric comorbidity (except anxiety or mild to moderate depression);
- Neurological comorbidity, if significant;
- Brain MRI showing:
- significant cerebrovascular pathology (Fazekas I admitted),
- another brain disease, including stroke.
- Major cognitive impairment;
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- Absolute exclusion criteria and "Red flags" of the 2015 criteria orienting towards another degenerative pathology of the extrapyramidal system:
- Cerebellar syndrome
- Vertical oculomotricity disorders on clinical examination
- Motor symptoms restricted to the lower limbs
- Bilateral and perfectly symmetrical parkinsonism
- Early dystonia
- Clinical profile suggestive of behavioral variant frontotemporal dementia (bvFTD)
- Progressive aphasia or apraxia
- Moderate or severe postural instability and / or early falls
- Early bulbar dysfunction (dysarthria, swallowing disorders)
- Ventilatory dysfunction (inspiration)
- Severe dysautonomia
- DOPA-resistance
- Neuroleptic treatment or related
- Normal MIBG myocardial scintigraphy (if performed).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kévin POLET contact
Monaco1 site, 1 recruiting
- Recruiting
Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
Monaco, 98000
Solange HESSE, +377 99995599, solange.hesse@chpg.mc
Kevin POLET, kevin.polet@chpg.mc
About this study
Official title: Video-oculography and Parkinson's Disease: A Prospective Study
This study aims to study, in patient with Parkinson's disease, mild to moderate stage (according to Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease, Postuma et al., 2015):
- the evolution of oculomotricity markers over time.
- the correlation between neurological evaluations (motor and non-motor scores), neuropsychological evaluations (cognitive disorders) and oculomotricity evaluation, over a follow-up period of 7 years.
- the impact of antiparkinsonian drugs on the evolution of oculomotricity assessment by video-oculography.
- the value of oculomotricity assessment by video-oculography as an evolutionary marker of the disease.
- Conditions
- Parkinson Disease, Idiopathic
- Being tested
- Video-oculography / Neuropsychological evaluations
- Keywords
- Parkinson's disease, Video-oculography, Oculomotor disorders, Oculomotricity, Neuropsychological evaluations, Movement disorder, Motor disorders, Non-motor fluctuations
- Medical subject headings
- Parkinson Disease, Movement Disorders, Motor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-oculography / Neuropsychological evaluationsOther
Annual evaluation: Medical history; Clinical, Neurological and Neuropsychological evaluations; Video-oculography examination; Inventory of examinations carried out in routine care (brain MRI, cerebral DaTScan, cerebral F-Dopa PET/CT scan, MIBG myocardial scintigraphy, blood test). Follow-up is carried out over 7 years.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease (mild to moderate stage) | Experimental | Not described Receives: Other: Video-oculography / Neuropsychological evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of Oculomotor raw performance at 7 years - Latency in Horizontal saccades.
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 SD compared to their reference sample.
Measured: Baseline; Year 7
Change from Baseline of Oculomotor raw performance at 7 years - Main velocity in Horizontal saccades.
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 SD compared to their reference sample.
Measured: Baseline; Year 7
Change from Baseline of Oculomotor raw performance at 7 years - Gain in Horizontal saccades.
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 SD compared to their reference sample.
Measured: Baseline; Year 7
Change from Baseline of Oculomotor raw performance at 7 years - Latency in Vertical saccades.
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; Year 7
Change from Baseline of Oculomotor raw performance at 7 years - Main velocity in Vertical saccades.
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; Year 7
Change from Baseline of Oculomotor raw performance at 7 years - Gain in Vertical saccades.
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; Year 7
Change from Baseline of Inhibition capacity at 7 years
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; Year 7
Change from Baseline of Internuclear ophthalmoplegia (INO) detection at 7 years
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; Year 7
Change from Baseline of Fixations impairments detection at 7 years
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; Year 7
Secondary outcomes (32)
Patients description
Profile description of included patients, based on demographic data and clinical exam (sex, age, Weight, height), inclusion/exclusion criteria, medical history, concomitant treatments.
Measured: Baseline
Treatments of Parkinson's disease
Description of PD treatments of included patients (Name, start date, end date, dose).
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Evolution of Oculomotor raw performance - Latency in Horizontal saccades
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 SD compared to their reference sample. Parameter used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Evolution of Oculomotor raw performance - Main velocity in Horizontal saccades.
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 SD compared to their reference sample. Parameter used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Evolution of Oculomotor raw performance - Gain in Horizontal saccades.
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 SD compared to their reference sample. Parameter used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Evolution of Oculomotor raw performance - Latency in Vertical saccades
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. Parameter used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Evolution of Oculomotor raw performance - Main velocity in Vertical saccades
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. Parameter used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Evolution of Oculomotor raw performance - Gain in Vertical saccades
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. Parameter used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
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. Parameter used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
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. Parameter used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
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. Parameter used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Neurological evaluation - evolution of motor disorders
Motor disorders are applause sign, Pyramidal signs, conjugate oculomotricity disorders, cerebellar syndrome. They are categorised as present/absent following neurological clinic evaluation. These parameters are used for description, evolution and correlation analysis.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Neurological evaluation - Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
Score on the Part III subscale of the MDS-UPDRS, that assesses the motor signs of PD. Scores range from 0-33 with a lower score indicating less severe impairment. These scores are used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Neurological evaluation - Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV
Score on the Part IV subscale of the MDS-UPDRS, that assesses the motor complications of PD. Scores range from 0-6 with a lower score indicating less severe impairment. These scores are used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Neurological evaluation - Movement Disorder Society Non-Motor rating Scale (MDS-NMS)
This Non-Motor rating Scale measures frequency and severity of 13 non-motor domains, over 52 items, and covers a range of key non-motor symptoms both PD and treatment related. The MDS-NMS total score is the sum of the 13 non-motors domains subscales scores (these subscales' scores are the sum of the frequency multiplied by the intensity of each items composing each 13 non-motor domains). Higher score means a worse outcome. Score range 0-832. These scores are used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Neurological evaluation - Movement Disorder Society Non-Motor rating Scale (MDS-NMS) Non-Motor Fluctuations (NMF)
The MDS-NMS has a Non-Motor Fluctuations subscale (NMF) to assess changes in non-motor symptoms in relation to the timing of anti-parkinsonian medications across 8 domains. The MDS-NMS NMF Total score is the Subscore "Change" (range 0-32) multiplied by Subscore "Time" (range 1-4). The MDS-NMS NMF Total score range is 0-128. Higher score means a worse outcome.
This score is used for description, evolution and correlation studies. [Time Frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable]
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Orthostatic hypotension
Blood pressure measures in order to determine presence or absence of Orthostatic hypotension. These parameters are used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
MRI scan
Brain MRI data described according to their nature (lesion / atrophy / anomaly / Score Fasekas) are classified as normal or abnormal.
Measured: Baseline; Year 3; Year 7
DAT scan
Cerebral DAT-Scan data are classified as presence/absence of Dopaminergic denervation.
Measured: Baseline; Year 3; Year 7
PET/CT scan
Cerebral F-Dopa PET/CT-Scan data are classified as presence/absence of Dopaminergic denervation.
Measured: Baseline; Year 3; Year 7
MIBG myocardial scintigraphy
MIBG myocardial scintigraphy are classified as normal/abnormal.
Measured: Baseline; Year 3; Year 7
Mini Mental State (MMSE)
Mini Mental State (MMSE) is used to evaluate Global cognitive performance. MMSE 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). Scores are used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Evolution of general cognitive behavior
The Mattis Dementia Rating Scale is used to to evaluate general cognitive behavior of subjects with suspected dementia. The scale is made up of 36 items divided into 5 complementary parts, each corresponding to a cognitive function: attention, initiation, construction, conceptualization, memory. The total score is /144 points. Score is used for description, evolution and comparison studies. Higher score means a better outcome.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Episodic memory performance
The GROBER et BUSCHKE Free and Cued recall (16 items) is used to evaluate Episodic memory. Performances of each participant are compared to their reference sample (depending on age, sex and level study). These parameters are used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Executive performance - T.M.T
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. These parameters are used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
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. These parameters are used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
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. These parameters are used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
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. These parameters are used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Visuospatial function
Visual Object and Space Perception battery (VOSP) consists of eight tests each designed to assess a particular aspect of object or space perception, while minimizing the involvement of other cognitive skills. Performance of each participant is compared to their reference sample.
This parameter is used for description, evolution and comparison studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
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. These parameters are used for description, evolution and comparison studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Praxis assessment
Praxies idéomotrices (Mahieux) is a neuropsychological measure of imitation of meaningless gestures (score /8), symbolic gestures (score /5), pantomimes (score /10). Motor praxis are also measured (kinesthetic praxis, melokinetic praxis). These parameters are used for description, evolution and correlation analysis.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Social cognition and Emotional assessment
A test battery made up of the Faux pas recognition test and a facial emotion recognition test (The Mini-sea) are used to evaluate Social cognition and Emotional assessment.
Evaluation criteria: Score to The Faux pas recognition test (/15), and scores to facial emotion recognition test (total score / 35 and sub-scores / 5). Performances of each participant are compared to their reference sample.
These parameters are used for description, evolution and correlation studies.
Measured: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
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 start7 Jul 2021
- Primary completionJan 2032 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease, IdiopathicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, descriptive, interventional, monocentric study. Participants perform an annual evaluation, which combine neurological and neuropsychological evaluations and a video-oculography examination. Follow-up is carried out over 7 years.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association de Recherche Bibliographique pour les Neurosciences
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Princesse Grace, Centre Hospitalier Universitaire de Nice
- Responsible party
- Sponsor
- Investigators
- Philippe BARRES, MD, Study director, Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco.Sandrine LOUCHART DE LA CHAPELLE, MD-PHD, Principal investigator, Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, MonacoAlain PESCE, PUPH, Study chair, AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)Caroline GIORDANA, MD, Principal investigator, Centre Expert Parkinson, Unités des Pathologies du Mouvement, Hôpital Pasteur 2, Nice (France)Benoit PAULMIER, MD, Principal investigator, Médecine Nucléaire, Princess Grace Hospital, Monaco.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731246
- Sponsor's protocol ID
- EYE-PD
- Status last verified
- Sep 2026
- First submitted
- 20 Jan 2021
- Last updated
- 13 Oct 2026
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-oculography and Parkinson's Disease: A Prospective Study
- ClinicalTrials.gov ID
- NCT04731246
- Acronym / sponsor ID
- EYE-PD
- Conditions
- Parkinson Disease, Idiopathic
- Keywords
- Parkinson's disease, Video-oculography, Oculomotor disorders, Oculomotricity, Neuropsychological evaluations, Movement disorder, Motor disorders, Non-motor fluctuations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Association de Recherche Bibliographique pour les NeurosciencesUniversity, hospital or other
- Collaborators
- Centre Hospitalier Princesse Grace, Centre Hospitalier Universitaire de Nice
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- Jan 2032 (estimated)
- Study completion
- Jan 2032 (estimated)
- 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.
This study aims to study, in patient with Parkinson's disease, mild to moderate stage (according to Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease, Postuma et al., 2015):
- the evolution of oculomotricity markers over time.
- the correlation between neurological evaluations (motor and non-motor scores), neuropsychological evaluations (cognitive disorders) and oculomotricity evaluation, over a follow-up period of 7 years.
- the impact of antiparkinsonian drugs on the evolution of oculomotricity assessment by video-oculography.
- the value of oculomotricity assessment by video-oculography as an evolutionary marker of the disease.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, descriptive, interventional, monocentric study. Participants perform an annual evaluation, which combine neurological and neuropsychological evaluations and a video-oculography examination. Follow-up is carried out over 7 years.
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease (mild to moderate stage) | Experimental | Other: Video-oculography / Neuropsychological evaluations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or Female;
- Clinically defined idiopathic Parkinson's Disease (PD);
- Brain MRI performed in routine care in the 12 months preceding inclusion;
- Cerebral DaTSCAN or cerebral PET with F-DOPA, performed as routine care before inclusion (no time limit), confirming presynaptic dopaminergic denervation;
- Hoehn \& Yahr score: 1 to 3;
Key exclusion criteria (21 listed)
- Psychiatric comorbidity (except anxiety or mild to moderate depression);
- Neurological comorbidity, if significant;
- Brain MRI showing:
- Major cognitive impairment;
- Absolute exclusion criteria and "Red flags" of the 2015 criteria orienting towards another degenerative pathology of the extrapyramidal system:
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 |
|---|---|---|
| Video-oculography / Neuropsychological evaluationsAnnual evaluation: Medical history; Clinical, Neurological and Neuropsychological evaluations; Video-oculography examination; Inventory of examinations carried out in routine care (brain MRI, cerebral DaTScan, cerebral F-Dopa PET/CT scan, MIBG myocardial scintigraphy, blood test). Follow-up is carried out over 7 years. | Other | Parkinson's disease (mild to moderate stage) |
Primary outcome
Change from Baseline of Oculomotor raw performance at 7 years - Latency in Horizontal saccades.
Time frame: Baseline; Year 7
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 SD compared to their reference sample.
Change from Baseline of Oculomotor raw performance at 7 years - Main velocity in Horizontal saccades.
Time frame: Baseline; Year 7
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 SD compared to their reference sample.
Change from Baseline of Oculomotor raw performance at 7 years - Gain in Horizontal saccades.
Time frame: Baseline; Year 7
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 SD compared to their reference sample.
Change from Baseline of Oculomotor raw performance at 7 years - Latency in Vertical saccades.
Time frame: Baseline; Year 7
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.
Change from Baseline of Oculomotor raw performance at 7 years - Main velocity in Vertical saccades.
Time frame: Baseline; Year 7
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.
Change from Baseline of Oculomotor raw performance at 7 years - Gain in Vertical saccades.
Time frame: Baseline; Year 7
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.
Change from Baseline of Inhibition capacity at 7 years
Time frame: Baseline; Year 7
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.
Change from Baseline of Internuclear ophthalmoplegia (INO) detection at 7 years
Time frame: Baseline; Year 7
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.
Change from Baseline of Fixations impairments detection at 7 years
Time frame: Baseline; Year 7
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.
32 secondary outcomes
Patients description
Time frame: Baseline
Treatments of Parkinson's disease
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Evolution of Oculomotor raw performance - Latency in Horizontal saccades
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Evolution of Oculomotor raw performance - Main velocity in Horizontal saccades.
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Evolution of Oculomotor raw performance - Gain in Horizontal saccades.
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Evolution of Oculomotor raw performance - Latency in Vertical saccades
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Evolution of Oculomotor raw performance - Main velocity in Vertical saccades
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Evolution of Oculomotor raw performance - Gain in Vertical saccades
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Inhibition capacity
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Internuclear ophthalmoplegia (INO) detection
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Fixations impairments detection
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Neurological evaluation - evolution of motor disorders
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Neurological evaluation - Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Neurological evaluation - Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Neurological evaluation - Movement Disorder Society Non-Motor rating Scale (MDS-NMS)
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Neurological evaluation - Movement Disorder Society Non-Motor rating Scale (MDS-NMS) Non-Motor Fluctuations (NMF)
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Orthostatic hypotension
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
MRI scan
Time frame: Baseline; Year 3; Year 7
DAT scan
Time frame: Baseline; Year 3; Year 7
PET/CT scan
Time frame: Baseline; Year 3; Year 7
MIBG myocardial scintigraphy
Time frame: Baseline; Year 3; Year 7
Mini Mental State (MMSE)
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Evolution of general cognitive behavior
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Episodic memory performance
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Executive performance - T.M.T
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Executive performance - Stroop test
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Executive performance - B.R.E.F.
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Verbal fluency
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Visuospatial function
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Visuospatial/constructional ability
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Praxis assessment
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Social cognition and Emotional assessment
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Kévin POLET contact
Philippe BARRES, MD study director
Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco.
Sandrine LOUCHART DE LA CHAPELLE, MD-PHD principal investigator
Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco
Alain PESCE, PUPH study chair
AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-oculography / Neuropsychological evaluations in people with Parkinson Disease, Idiopathic, 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?
The sponsor lists 11 inclusion and 21 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Solange HESSE (+377 99995599, solange.hesse@chpg.mc), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline of Oculomotor raw performance at 7 years - Latency in Horizontal saccades. (time frame: Baseline; Year 7). The study lists 9 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 13 Oct 2026.