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Recruiting NCT04731246

Video-oculography and Parkinson's Disease

No phase Interventional Parkinson Disease, Idiopathic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Video-oculography / Neuropsychological evaluations.
Who it may be relevant to
Registry conditions: Parkinson Disease, Idiopathic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Monaco
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Video-oculography and Parkinson's Disease: A Prospective Study

Overview

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.

Interventions

  • Other Video-oculography / Neuropsychological evaluations
    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 measures

  • Change from Baseline of Oculomotor raw performance at 7 years - Latency in Horizontal saccades. [Time frame: Baseline; Year 7]
  • Change from Baseline of Oculomotor raw performance at 7 years - Main velocity in Horizontal saccades. [Time frame: Baseline; Year 7]
  • Change from Baseline of Oculomotor raw performance at 7 years - Gain in Horizontal saccades. [Time frame: Baseline; Year 7]
  • Change from Baseline of Oculomotor raw performance at 7 years - Latency in Vertical saccades. [Time frame: Baseline; Year 7]
  • Change from Baseline of Oculomotor raw performance at 7 years - Main velocity in Vertical saccades. [Time frame: Baseline; Year 7]
  • Change from Baseline of Oculomotor raw performance at 7 years - Gain in Vertical saccades. [Time frame: Baseline; Year 7]
  • Change from Baseline of Inhibition capacity at 7 years [Time frame: Baseline; Year 7]
  • Change from Baseline of Internuclear ophthalmoplegia (INO) detection at 7 years [Time frame: Baseline; Year 7]
  • Change from Baseline of Fixations impairments detection at 7 years [Time frame: Baseline; Year 7]
Secondary outcome measures (12)
  • 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]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Monaco · 1 center
  • Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital — Monaco

Identifiers

NCT: NCT04731246 · EYE-PD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗