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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
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.
Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
Monaco, Monaco
RECRUITINGChange 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline; Year 7
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.
Time frame: Baseline
Treatments of Parkinson's disease
Description of PD treatments of included patients (Name, start date, end date, dose).
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
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.
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.
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.
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.
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.
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
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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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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)
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.
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)
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. \[Time Frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable\]
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
Blood pressure measures in order to determine presence or absence of Orthostatic hypotension. These parameters are 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
MRI scan
Brain MRI data described according to their nature (lesion / atrophy / anomaly / Score Fasekas) are classified as normal or abnormal.
Time frame: Baseline; Year 3; Year 7
DAT scan
Cerebral DAT-Scan data are classified as presence/absence of Dopaminergic denervation.
Time frame: Baseline; Year 3; Year 7
PET/CT scan
Cerebral F-Dopa PET/CT-Scan data are classified as presence/absence of Dopaminergic denervation.
Time frame: Baseline; Year 3; Year 7
MIBG myocardial scintigraphy
MIBG myocardial scintigraphy are classified as normal/abnormal.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7