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| Name | Class |
|---|---|
| Hospitales Universitarios Virgen del RocÃo | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson patients | Active Comparator | Patients diagnosed with Parkinson's disease, ages 50-80, Hoehn & Yahr scale 1-3 |
|
| PSP patients | Active Comparator | Patients diagnosed with PSP, according to actual diagnostic criteria from Höglinger GU et al, 2017. |
|
| MSA patients | Active Comparator | Patients diagnosed with MSA, according to actual diagnostic criteria from Wenning et al, 2022. |
|
| Healthy | Active Comparator | Healthy subjects with no neurological diseases or cognition deficits |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuraLight PD | Other | NeuraLight software-based platform for PD patients |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between MoCA score and its parts with anti-saccadic error rates | 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 |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Mir, MD | IBIS (Instituto de Biomedicina de Sevilla), Calle Antonio Maura Montaner, Seville, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Biomedicina de Sevilla (IBiS) | Seville | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35501501 | Background | 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D013494 | Supranuclear Palsy, Progressive |
| D019578 | Multiple System Atrophy |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| NeuraLight PSP |
| Other |
NeuraLight software-based platform for PSP patients |
|
| NeuraLight MSA | Other | NeuraLight software-based platform for MSA patients |
|
| NeuraLight | Other | NeuraLight software-based platform |
|
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 |
| 12 months |
| Correlation between MoCA score and its parts with smooth pursuit | 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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009886 | Ophthalmoplegia |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D024801 | Tauopathies |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |