Multiple System Atrophy, Parkinson Disease, Progressive Supranuclear Palsy(PSP)
Conditions
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.
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.
Interventions
OTHERNeuraLight PD
NeuraLight software-based platform for PD patients
OTHERNeuraLight PSP
NeuraLight software-based platform for PSP patients
OTHERNeuraLight MSA
NeuraLight software-based platform for MSA patients
OTHERNeuraLight
NeuraLight software-based platform
Sponsors
Hospitales Universitarios Virgen del Rocío
NeuraLight
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between PSP-CDS and its parts with saccadic latency | 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) |
| Correlation between MDS-UPDRS score and its parts with saccadic latency | 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) |
| Correlation between UMSARS score and its parts with saccadic latency | 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) |
| Change of saccadic latency between subgroups | 12 months | A difference between saccadic latency among the cohorts, enabling a categorization of different patients in study cohorts (p\<0.05) |
| Change of antisaccadic error rate between subgroups | 12 months | A difference between antisaccadic error rate (%) among the cohorts, enabling a categorization of different patients in study cohorts (p\<0.05) |
| Change of saccadic latency over time as evaluated during visits | 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 |
| Change of antisaccadic error rate over time as evaluated during visits | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between MoCA score and its parts with smooth pursuit | 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 |
| Correlation between MoCA score and its parts with anti-saccadic error rates | 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 |
Countries
Spain
Outcome results
None listed