Video-oculography and Parkinson's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssociation de Recherche Bibliographique pour les Neurosciences

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Video-oculography / Neuropsychological evaluations

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Parkinson's disease (mild to moderate stage)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline; Year 7
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Association de Recherche Bibliographique pour les Neurosciences

Lead sponsor

Centre Hospitalier Princesse Grace

Collaborator

Centre Hospitalier Universitaire de Nice

Collaborator