Status:
RECRUITING
Video-oculography and Parkinson's Disease
Lead Sponsor:
Association de Recherche Bibliographique pour les Neurosciences
Collaborating Sponsors:
Centre Hospitalier Princesse Grace
Centre Hospitalier Universitaire de Nice
Conditions:
Parkinson Disease, Idiopathic
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- \*
- 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
- 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).
Key Trial Info
Start Date :
July 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2032
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04731246
Start Date
July 7 2021
End Date
January 1 2032
Last Update
October 1 2025
Active Locations (1)
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1
Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
Monaco, Monaco, 98000