Parkinson Atypical Rating of Oculometric Patterns Evaluated Routinely

NCT06597071 | Enrolling By Invitation

• 1 other identifier: NL/APD/2024-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Progressive Supranuclear Palsy(PSP); Multiple System Atrophy

Outcome Measures

Primary Outcomes (7)

• Change of saccadic latency between subgroups

  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

  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 saccadic latency over time as evaluated during visits

  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

• Change of antisaccadic error rate over time as evaluated during visits

  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

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

  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

  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

  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

Secondary Outcomes (2)

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

  12 months

• Correlation between MoCA score and its parts with smooth pursuit

  12 months

Study Arms (4)

Parkinson patients

ACTIVE COMPARATOR

Patients diagnosed with Parkinson's disease, ages 50-80, Hoehn \& Yahr scale 1-3

Other: NeuraLight PD

PSP patients

ACTIVE COMPARATOR

Patients diagnosed with PSP, according to actual diagnostic criteria from Höglinger GU et al, 2017.

Other: NeuraLight PSP

MSA patients

ACTIVE COMPARATOR

Patients diagnosed with MSA, according to actual diagnostic criteria from Wenning et al, 2022.

Other: NeuraLight MSA

Healthy

ACTIVE COMPARATOR

Healthy subjects with no neurological diseases or cognition deficits

Other: NeuraLight

Interventions

NeuraLight PD OTHER

NeuraLight software-based platform for PD patients

Parkinson patients

NeuraLight PSP OTHER

NeuraLight software-based platform for PSP patients

PSP patients

NeuraLight MSA OTHER

NeuraLight software-based platform for MSA patients

MSA patients

NeuraLight OTHER

NeuraLight software-based platform

Healthy

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• NeuraLight: lead
• Hospitales Universitarios Virgen del Rocío: collaborator

Study Sites (1)

Instituto de Biomedicina de Sevilla (IBiS)

Seville, Spain

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Supranuclear Palsy, Progressive; Multiple System Atrophy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Primary Dysautonomias; Autonomic Nervous System Diseases

Study Officials

• Pablo Mir, MD

  IBIS (Instituto de Biomedicina de Sevilla), Calle Antonio Maura Montaner, Seville, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: September 10, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 11, 2025

Record last verified: 2024-09

Locations

ES (1)