Parkinson Atypical Rating of Oculometric Patterns Evaluated Routinely (PARATROOPER)

March 5, 2025 updated by: NeuraLight

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Sevilla, Spain
        • Instituto de Biomedicina de Sevilla (IBiS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Parkinson patients
Patients diagnosed with Parkinson's disease, ages 50-80, Hoehn & Yahr scale 1-3
Other: NeuraLight PD
NeuraLight software-based platform for PD patients
Active Comparator: PSP patients
Patients diagnosed with PSP, according to actual diagnostic criteria from Höglinger GU et al, 2017.
Other: NeuraLight PSP
NeuraLight software-based platform for PSP patients
Active Comparator: MSA patients
Patients diagnosed with MSA, according to actual diagnostic criteria from Wenning et al, 2022.
Other: NeuraLight MSA
NeuraLight software-based platform for MSA patients
Active Comparator: Healthy
Healthy subjects with no neurological diseases or cognition deficits
Other: NeuraLight
NeuraLight software-based platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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)
12 months
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)
12 months
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)
12 months
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)
12 months
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)
12 months
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuraLight

Collaborators

Hospitales Universitarios Virgen del Rocío

Investigators

  • Principal Investigator: Pablo Mir, MD, IBIS (Instituto de Biomedicina de Sevilla), Calle Antonio Maura Montaner, Seville, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

September 11, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL/APD/2024-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe