Video-oculography and Parkinson's Disease

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (12)

• Patients description [Срок оценки: Baseline]
• Treatments of Parkinson's disease [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable]

Критерии участия

\*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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Monaco · 1 центр

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

Идентификаторы

NCT: NCT04731246 · EYE-PD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗