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Parkinson Atypical Rating of Oculometric Patterns Evaluated Routinely

Not Applicable
Conditions
Parkinson Disease
Progressive Supranuclear Palsy(PSP)
Multiple System Atrophy
Interventions
Other: NeuraLight PD
Other: NeuraLight PSP
Other: NeuraLight MSA
Other: NeuraLight
Registration Number
NCT06597071
Lead Sponsor
NeuraLight
Brief Summary

This is an observational cross-sectional study in 4 cohorts of patients with parkinsonian syndromes and healthy subjects, 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 as compared to clinical diagnosis, in order to find a correlation 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. 30 minutes. The oculometric evaluation will occur at baseline, 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.

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
40
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.
Read More
Exclusion Criteria
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Parkinson patientsNeuraLight PDPatients diagnosed with Parkinson's disease, ages 50-80, Hoehn \& Yahr scale 1-3
PSP patientsNeuraLight PSPPatients diagnosed with PSP, according to actual diagnostic criteria from Höglinger GU et al, 2017.
MSA patientsNeuraLight MSAPatients diagnosed with MSA, according to actual diagnostic criteria from Wenning et al, 2022.
HealthyNeuraLightHealthy subjects with no neurological diseases or cognition deficits
Primary Outcome Measures
NameTimeMethod
Correlation between MDS-UPDRS score and its parts with saccadic latency12 months

The correlation between the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS, scored 0-to a maximum total of 199, indicating the worst possible disability from PD) and its parts with saccadic latency (ms) measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05)

Correlation between UMSARS score and its parts with saccadic latency12 months

The correlation between the Unified Multiple System Atrophy Rating Scale (UMSARS) scored 0-to a maximum total of 48, indicating the worst possible disability from MSA) and its parts with saccadic latency (ms) measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05)

Correlation between PSP-CDS and its parts with saccadic latency12 months

The correlation between the Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS) scored 0-to a maximum total of 100, indicating the worst possible disability from MSA) and its parts with saccadic latency (ms) measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05)

Secondary Outcome Measures
NameTimeMethod
Correlation between MoCA score and its parts with anti-saccadic error rates12 months

The correlation between the Montreal Cognitive Assessment (MoCA, scored 0- to a total possible score is 30 points, where a score of 26 or above is considered normal) with anti-saccadic error rates (%), measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05) according to the Montreal Cognitive Assessment (MoCA) at visits

Correlation between MoCA score and its parts with smooth pursuit12 months

The correlation between Montreal Cognitive Assessment (MoCA, scored 0- to a total possible score is 30 points, where a score of 26 or above is considered normal) with smooth pursuit speed (ms) measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05) according to the Montreal Cognitive Assessment (MoCA) at visits

Trial Locations

Locations (1)

Instituto de Biomedicina de Sevilla (IBiS)

🇪🇸

Sevilla, Spain

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