Clinical trial NCT06597071: Parkinson Atypical Rating of Oculometric Patterns Evaluated Routinely
Official title: Use of Oculometric Measures in the Differential Diagnosis of Typical and Atypical Parkinsonian Conditions: a Pilot Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Parkinson Disease
Progressive Supranuclear Palsy(PSP)
Multiple System Atrophy
Lead sponsor: NeuraLight
Sponsor class: INDUSTRY
Collaborators: name: Hospitales Universitarios Virgen del Rocío
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

-

Primary outcomes:
measure: Change of saccadic latency between subgroups
timeFrame: 12 months
measure: Change of antisaccadic error rate between subgroups
timeFrame: 12 months
measure: Change of saccadic latency over time as evaluated during visits
timeFrame: 12 months
measure: Change of antisaccadic error rate over time as evaluated during visits
timeFrame: 12 months
measure: Correlation between MDS-UPDRS score and its parts with saccadic latency
timeFrame: 12 months
measure: Correlation between UMSARS score and its parts with saccadic latency
timeFrame: 12 months
measure: Correlation between PSP-CDS and its parts with saccadic latency
timeFrame: 12 months
Secondary outcomes:
measure: Correlation between MoCA score and its parts with anti-saccadic error rates
timeFrame: 12 months
measure: Correlation between MoCA score and its parts with smooth pursuit
timeFrame: 12 months
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Instituto de Biomedicina de Sevilla (IBiS)
Study officials:
affiliation: IBIS (Instituto de Biomedicina de Sevilla), Calle Antonio Maura Montaner, Seville, Spain
name: Pablo Mir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.