Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2021-07-07
2032-01-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
Follow-up is carried out over 7 years.
OTHER
NONE
Study Groups
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Parkinson's disease (mild to moderate stage)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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;
* 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).
18 Years
ALL
No
Sponsors
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Centre Hospitalier Princesse Grace
OTHER
Centre Hospitalier Universitaire de Nice
OTHER
Association de Recherche Bibliographique pour les Neurosciences
OTHER
Responsible Party
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Principal Investigators
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Philippe BARRES, MD
Role: STUDY_DIRECTOR
Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco.
Sandrine LOUCHART DE LA CHAPELLE, MD-PHD
Role: PRINCIPAL_INVESTIGATOR
Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco
Alain PESCE, PUPH
Role: STUDY_CHAIR
AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)
Caroline GIORDANA, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Expert Parkinson, Unités des Pathologies du Mouvement, Hôpital Pasteur 2, Nice (France)
Benoit PAULMIER, MD
Role: PRINCIPAL_INVESTIGATOR
Médecine Nucléaire, Princess Grace Hospital, Monaco.
Locations
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Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
Monaco, , Monaco
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EYE-PD
Identifier Type: -
Identifier Source: org_study_id
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