Parkinson Atypical Rating of Oculometric Patterns Evaluated Routinely

Официальное название

Use of Oculometric Measures in the Differential Diagnosis of Typical and Atypical Parkinsonian Conditions: a Pilot Study

Обзор

This is an observational longitudinal study in 4 cohorts of patients with Parkinsonian syndromes, who are visiting the Movement Disorders outpatient clinics. The aim of the study is to assess the difference of oculometric measures in different neurodegenerative brain conditions and their accuracy over time, and as compared to clinical diagnosis, in order to find a change over time, difference between subgroups and correlations with accepted clinical endpoints in subjects who meet the inclusion criteria and who provide a signed Informed Consent.

Подробное описание

As a part of the study, about 40 subjects will undergo a neurological evaluation including motor and cognitive assessments and a NeuraLight session including oculometric measurements and eye-tracking recordings using a novel software-based platform and an eye-tracking system (Tobii, CE-marked class B approved device). Test duration will be approx. 20 minutes. The oculometric evaluation will occur for at least 50% of the cohort 3 times (at baseline, at 6-months and at 12-month follow-up), and all subjects will be recruited over a period of 9 months. All assessments will be performed during a clinic visit unless authorized to be conducted remotely.

Вмешательства

• Другое NeuraLight PD
  NeuraLight software-based platform for PD patients
• Другое NeuraLight PSP
  NeuraLight software-based platform for PSP patients
• Другое NeuraLight MSA
  NeuraLight software-based platform for MSA patients
• Другое NeuraLight
  NeuraLight software-based platform

Первичные конечные точки

• Change of saccadic latency between subgroups [Срок оценки: 12 months]
• Change of antisaccadic error rate between subgroups [Срок оценки: 12 months]
• Change of saccadic latency over time as evaluated during visits [Срок оценки: 12 months]
• Change of antisaccadic error rate over time as evaluated during visits [Срок оценки: 12 months]
• Correlation between MDS-UPDRS score and its parts with saccadic latency [Срок оценки: 12 months]
• Correlation between UMSARS score and its parts with saccadic latency [Срок оценки: 12 months]
• Correlation between PSP-CDS and its parts with saccadic latency [Срок оценки: 12 months]

Вторичные конечные точки (2)

• Correlation between MoCA score and its parts with anti-saccadic error rates [Срок оценки: 12 months]
• Correlation between MoCA score and its parts with smooth pursuit [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Men and women, age between 40 and 80 years
• <5 years since disease diagnosis
• Normal or corrected vision
• MOCA score ≥ 20
• Ability to follow instructions
• Willing and able to sign an informed consent form Specific
• PD cohort: Ages 50-80, Hoehn \& Yahr scale 1-3
• PSP cohort: diagnosed according to actual diagnostic criteria from Höglinger GU et al, 2017.
• MSA cohort: diagnosed according to actual diagnostic criteria from Wenning et al, 2022.

Критерии исключения

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Испания · 1 центр

• Instituto de Biomedicina de Sevilla (IBiS) — Seville

Публикации

• Habibi M, Oertel WH, White BJ, Brien DC, Coe BC, Riek HC, Perkins J, Yep R, Itti L, Timmermann L, Best C, Sittig E, Janzen A, Munoz DP. Eye tracking identifies biomarkers in alpha-synucleinopathies versus progressive supranuclear palsy. J Neurol. 2022 Sep;269(9):4920-4938. doi: 10.1007/s00415-022-11136-5. Epub 2022 Apr 30. PMID 35501501

Идентификаторы

NCT: NCT06597071 · NL/APD/2024-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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