Video-oculography and Parkinson's Disease

Association de Recherche Bibliographique pour les Neurosciences

Status: Enrolling

Conditions: Parkinson Disease, Idiopathic

Treatments: Other: Video-oculography / Neuropsychological evaluations

Study type: Interventional

Funder types: Other

Identifiers

NCT04731246

EYE-PD

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

*Inclusion Criteria:

1. Male or Female;

2. Clinically defined idiopathic Parkinson's Disease (PD);

3. Brain MRI performed in routine care in the 12 months preceding inclusion;

4. Cerebral DaTSCAN or cerebral PET with F-DOPA, performed as routine care before inclusion (no time limit), confirming presynaptic dopaminergic denervation;

5. Hoehn & Yahr score: 1 to 3;

6. Normal clinical examination of oculomotricity (slight impairment of smooth pursuit accepted);

7. Neuro-cognitive disorders: absent or minor (according to DSM5);

8. Sufficient written and oral expression in French;

9. Covered by a health insurance system;

10. Written informed consent signed by the patient;

11. Presence of a caregiver.

    * Exclusion Criteria:

12. Psychiatric comorbidity (except anxiety or mild to moderate depression);

13. Neurological comorbidity, if significant;

14. Brain MRI showing:

    1. significant cerebrovascular pathology (Fazekas I admitted),
    2. another brain disease, including stroke.

15. Major cognitive impairment;

16. 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

17. Normal MIBG myocardial scintigraphy (if performed).

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Parkinson's disease (mild to moderate stage)

Experimental group

Treatment:

Other: Video-oculography / Neuropsychological evaluations