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Enrolling by Invitation

NCT Number: NCT06597071

Parkinson Atypical Rating of Oculometric Patterns Evaluated Routinely

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.

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Key information

Conditions

Parkinson Disease Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cranial Nerve Diseases Eye Diseases Movement Disorders Multiple System Atrophy Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Ocular Motility Disorders Ophthalmoplegia Paralysis Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Primary Dysautonomias Progressive Supranuclear Palsy(PSP) Signs and Symptoms Supranuclear Palsy, Progressive Synucleinopathies Tauopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Biomedicina de Sevilla (IBiS)

Seville, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

NeuraLight PD

Other

NeuraLight software-based platform for PD patients

NeuraLight PSP

Other

NeuraLight software-based platform for PSP patients

NeuraLight MSA

Other

NeuraLight software-based platform for MSA patients

NeuraLight

Other

NeuraLight software-based platform

Primary outcomes

  1. Change of saccadic latency between subgroups

    Time frame: 12 months

    A difference between saccadic latency among the cohorts, enabling a categorization of different patients in study cohorts (p<0.05)

  2. Change of antisaccadic error rate between subgroups

    Time frame: 12 months

    A difference between antisaccadic error rate (%) among the cohorts, enabling a categorization of different patients in study cohorts (p<0.05)

  3. Change of saccadic latency over time as evaluated during visits

    Time frame: 12 months

    Difference between saccadic latency (ms) as quantified during each visit by the NeuraLight test measured using a statistical comparison of values (e.g. t-test, ANOVA), p>0.05) over time during study period

  4. Change of antisaccadic error rate over time as evaluated during visits

    Time frame: 12 months

    Difference between antisaccadic error rate (%) as quantified during each visit by the NeuraLight test measured using a statistical comparison of values (e.g. t-test, ANOVA), p>0.05) over time during study period

  5. Correlation between MDS-UPDRS score and its parts with saccadic latency

    Time frame: 12 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)

  6. Correlation between UMSARS score and its parts with saccadic latency

    Time frame: 12 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)

  7. Correlation between PSP-CDS and its parts with saccadic latency

    Time frame: 12 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 outcomes

  1. Correlation between MoCA score and its parts with anti-saccadic error rates

    Time frame: 12 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

  2. Correlation between MoCA score and its parts with smooth pursuit

    Time frame: 12 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

Sponsors and collaborators

Lead sponsor

NeuraLight

Industry

Collaborators

  • Hospitales Universitarios Virgen del Rocío

Registry information

Official study title

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

Acronym: PARATROOPER

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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