Parkinson Atypical Rating of Oculometric Patterns Evaluated Routinely (PARATROOPER)

NeuraLight

Status: Invitation-only

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

Treatments: Other: NeuraLight MSA; Other: NeuraLight PSP; Other: NeuraLight PD; Other: NeuraLight

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06597071

NL/APD/2024-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 4 patient groups

Parkinson patients

Active Comparator group

Description:

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

Treatment:

Other: NeuraLight PD

PSP patients

Active Comparator group

Description:

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

Treatment:

Other: NeuraLight PSP

MSA patients

Active Comparator group

Description:

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

Treatment:

Other: NeuraLight MSA

Healthy

Active Comparator group

Description:

Healthy subjects with no neurological diseases or cognition deficits

Treatment:

Other: NeuraLight