Parkinson Atypical Rating of Oculometric Patterns Evaluated Routinely

NCT ID: NCT06597071

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-10

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Parkinson Disease Progressive Supranuclear Palsy(PSP) Multiple System Atrophy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Parkinson patients

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

Group Type ACTIVE_COMPARATOR

NeuraLight PD

Intervention Type OTHER

NeuraLight software-based platform for PD patients

PSP patients

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

Group Type ACTIVE_COMPARATOR

NeuraLight PSP

Intervention Type OTHER

NeuraLight software-based platform for PSP patients

MSA patients

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

Group Type ACTIVE_COMPARATOR

NeuraLight MSA

Intervention Type OTHER

NeuraLight software-based platform for MSA patients

Healthy

Healthy subjects with no neurological diseases or cognition deficits

Group Type ACTIVE_COMPARATOR

NeuraLight

Intervention Type OTHER

NeuraLight software-based platform

Interventions

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NeuraLight PD

NeuraLight software-based platform for PD patients

Intervention Type OTHER

NeuraLight PSP

NeuraLight software-based platform for PSP patients

Intervention Type OTHER

NeuraLight MSA

NeuraLight software-based platform for MSA patients

Intervention Type OTHER

NeuraLight

NeuraLight software-based platform

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospitales Universitarios Virgen del Rocío

OTHER

Sponsor Role collaborator

NeuraLight

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pablo Mir, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Instituto de Biomedicina de Sevilla (IBiS)

Seville, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 35501501 (View on PubMed)

Other Identifiers

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NL/APD/2024-1

Identifier Type: -

Identifier Source: org_study_id

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