Back to resultsVideo-oculography and Parkinson's Disease
Primary Purpose
Parkinson Disease, Idiopathic
Status
Recruiting
Phase
Not Applicable
Locations
Monaco
Study Type
Interventional
Intervention
Video-oculography / Neuropsychological evaluations
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease, Idiopathic focused on measuring Parkinson's disease, Video-oculography, Oculomotor disorders, Oculomotricity, Neuropsychological evaluations, Movement disorder, Motor disorders, Non-motor fluctuations
Eligibility Criteria
*Inclusion Criteria:
- 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);
- 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.
* Exclusion Criteria:
- 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;
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).
Sites / Locations
- Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Parkinson's disease (mild to moderate stage)
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
Treatments of Parkinson's disease
Description of PD treatments of included patients (Name, start date, end date, dose).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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]
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.
MRI scan
Brain MRI data described according to their nature (lesion / atrophy / anomaly / Score Fasekas) are classified as normal or abnormal.
DAT scan
Cerebral DAT-Scan data are classified as presence/absence of Dopaminergic denervation.
PET/CT scan
Cerebral F-Dopa PET/CT-Scan data are classified as presence/absence of Dopaminergic denervation.
MIBG myocardial scintigraphy
MIBG myocardial scintigraphy are classified as normal/abnormal.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04731246
First Posted
January 20, 2021
Last Updated
January 31, 2023
Sponsor
Association de Recherche Bibliographique pour les Neurosciences
Collaborators
Centre Hospitalier Princesse Grace, Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04731246
Brief Title
Video-oculography and Parkinson's Disease
Official Title
Video-oculography and Parkinson's Disease: A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
January 2029 (Anticipated)
Study Completion Date
January 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association de Recherche Bibliographique pour les Neurosciences
Collaborators
Centre Hospitalier Princesse Grace, Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Idiopathic
Keywords
Parkinson's disease, Video-oculography, Oculomotor disorders, Oculomotricity, Neuropsychological evaluations, Movement disorder, Motor disorders, Non-motor fluctuations
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Parkinson's disease (mild to moderate stage)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Video-oculography / Neuropsychological evaluations
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline of Oculomotor raw performance at 7 years - Latency in Horizontal saccades.
Description
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
Title
Change from Baseline of Oculomotor raw performance at 7 years - Main velocity in Horizontal saccades.
Description
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
Title
Change from Baseline of Oculomotor raw performance at 7 years - Gain in Horizontal saccades.
Description
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
Title
Change from Baseline of Oculomotor raw performance at 7 years - Latency in Vertical saccades.
Description
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
Title
Change from Baseline of Oculomotor raw performance at 7 years - Main velocity in Vertical saccades.
Description
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
Title
Change from Baseline of Oculomotor raw performance at 7 years - Gain in Vertical saccades.
Description
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
Title
Change from Baseline of Inhibition capacity at 7 years
Description
Measure of inhibition capacity performance during an "antisaccades" paradigm. Eye movements were recorded and analyzed with an eye-tracking device. Evaluation criteria: percentage of errors. For each subject value were judged abnormal if they differed by >1.65 SD compared to their reference sample.
Time Frame
Baseline; Year 7
Title
Change from Baseline of Internuclear ophthalmoplegia (INO) detection at 7 years
Description
Highlight presence/absence of INO. Eye movements were recorded and analyzed with an eye-tracking device. Evaluation criteria: INO is present if calculated ratio of abducting to adducting eye movement (both mean and peak velocity) is >1.
Time Frame
Baseline; Year 7
Title
Change from Baseline of Fixations impairments detection at 7 years
Description
Highlight presence/absence of Fixations impairments. Eye movements were recorded and analyzed with an eye-tracking device. Evaluation criteria: presence/absence/frequency of square wave-jerks, nystagmus, flutters.
Time Frame
Baseline; Year 7
Secondary Outcome Measure Information:
Title
Patients description
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
Title
Treatments of Parkinson's disease
Description
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
Title
Evolution of Oculomotor raw performance - Latency in Horizontal saccades
Description
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
Title
Evolution of Oculomotor raw performance - Main velocity in Horizontal saccades.
Description
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
Title
Evolution of Oculomotor raw performance - Gain in Horizontal saccades.
Description
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
Title
Evolution of Oculomotor raw performance - Latency in Vertical saccades
Description
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
Title
Evolution of Oculomotor raw performance - Main velocity in Vertical saccades
Description
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
Title
Evolution of Oculomotor raw performance - Gain in Vertical saccades
Description
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
Title
Inhibition capacity
Description
Measure of inhibition capacity performance during an "antisaccades" paradigm. Eye movements were recorded and analyzed with an eye-tracking device. Evaluation criteria: percentage of errors. For each subject value were judged abnormal if they differed by >1.65 SD compared to their reference sample. 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
Title
Internuclear ophthalmoplegia (INO) detection
Description
Highlight presence/absence of INO. Eye movements were recorded and analyzed with an eye-tracking device. Evaluation criteria: INO is present if calculated ratio of abducting to adducting eye movement (both mean and peak velocity) is >1. 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
Title
Fixations impairments detection
Description
Highlight presence/absence of Fixations impairments. Eye movements were recorded and analyzed with an eye-tracking device. Evaluation criteria: presence/absence/frequency of square wave-jerks, nystagmus, flutters. 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
Title
Neurological evaluation - evolution of motor disorders
Description
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
Title
Neurological evaluation - Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
Description
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
Title
Neurological evaluation - Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV
Description
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
Title
Neurological evaluation - Movement Disorder Society Non-Motor rating Scale (MDS-NMS)
Description
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
Title
Neurological evaluation - Movement Disorder Society Non-Motor rating Scale (MDS-NMS) Non-Motor Fluctuations (NMF)
Description
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
Title
Orthostatic hypotension
Description
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
Title
MRI scan
Description
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
Title
DAT scan
Description
Cerebral DAT-Scan data are classified as presence/absence of Dopaminergic denervation.
Time Frame
Baseline; Year 3; Year 7
Title
PET/CT scan
Description
Cerebral F-Dopa PET/CT-Scan data are classified as presence/absence of Dopaminergic denervation.
Time Frame
Baseline; Year 3; Year 7
Title
MIBG myocardial scintigraphy
Description
MIBG myocardial scintigraphy are classified as normal/abnormal.
Time Frame
Baseline; Year 3; Year 7
Title
Mini Mental State (MMSE)
Description
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
Title
Evolution of general cognitive behavior
Description
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
Title
Episodic memory performance
Description
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
Title
Executive performance - T.M.T
Description
Trail Making Test (T.M.T) A&B is used to evaluate executive performance. The task requires a subject to connect a sequence of 25 consecutive targets on a sheet of paper, in the shortest time possible without lifting the pen from the paper. Time performances of each participant are compared to their reference sample. 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
Title
Executive performance - Stroop test
Description
Stroop test (GREFFEX) is used to evaluate executive performance and more specifically inhibition. The time to complete each condition (in seconds) is recorded, as well as the number of uncorrected and corrected errors. Stroop task performances of each participant are compared to their reference sample. 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
Title
Executive performance - B.R.E.F.
Description
The "Batterie rapide d'évaluation frontale" (B.R.E.F.), or Frontal Assessment Battery at Bedside (F.A.B.), is used to determine the presence or not of a cognitive and behavioral dysexecution syndrom. The maximum score is 18. Performances of each participant are compared to their reference sample. 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
Title
Verbal fluency
Description
Verbal fluency test is a short test of verbal functioning. It consists of two tasks: category fluency and letter fluency. Participant is given 1 minute to produce as many unique words as possible within a semantic category (category fluency) or starting with a given letter (letter fluency). The participant's score in each task is the number of unique correct words. Performances of each participant are compared to their reference sample. 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
Title
Visuospatial function
Description
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
Title
Visuospatial/constructional ability
Description
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
Title
Praxis assessment
Description
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
Title
Social cognition and Emotional assessment
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
*Inclusion Criteria:
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);
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.
* Exclusion Criteria:
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;
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Solange HESSE
Phone
+377 99995599
Email
solange.hesse@chpg.mc
First Name & Middle Initial & Last Name or Official Title & Degree
Kévin POLET
Email
kevin.polet@chpg.mc
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe BARRES, MD
Organizational Affiliation
Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sandrine LOUCHART DE LA CHAPELLE, MD-PHD
Organizational Affiliation
Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alain PESCE, PUPH
Organizational Affiliation
AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Caroline GIORDANA, MD
Organizational Affiliation
Centre Expert Parkinson, Unités des Pathologies du Mouvement, Hôpital Pasteur 2, Nice (France)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benoit PAULMIER, MD
Organizational Affiliation
Médecine Nucléaire, Princess Grace Hospital, Monaco.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
City
Monaco
ZIP/Postal Code
98000
Country
Monaco
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Solange HESSE
Phone
+377 99995599
Email
solange.hesse@chpg.mc
First Name & Middle Initial & Last Name & Degree
Kevin POLET
Email
kevin.polet@chpg.mc
First Name & Middle Initial & Last Name & Degree
Sandrine LOUCHART DE LA CHAPELLE, MD-PHD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Video-oculography and Parkinson's Disease
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