About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Psychiatric comorbidity (except anxiety or mild to moderate depression);
Neurological comorbidity, if significant;
significant cerebrovascular pathology (Fazekas I admitted),
another brain disease, including stroke.
Trial design
Single group
Treatments tested in this trial
Video-oculography / Neuropsychological evaluations
Other interventionAnnual 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Sponsors and contacts
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Association de Recherche Bibliographique pour les Neurosciences
Lead sponsor
Centre Hospitalier Princesse Grace
Collaborator
Centre Hospitalier Universitaire de Nice
Collaborator