Parkinson DiseasePARATROOPERNCT06597071
Parkinson Atypical Rating of Oculometric Patterns Evaluated Routinely
A study testing NeuraLight PD, NeuraLight PSP and NeuraLight MSA in people with Parkinson Disease and Progressive Supranuclear Palsy(PSP), run by NeuraLight at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Progressive Supranuclear Palsy(PSP), Multiple System Atrophy
- What is being tested?
- NeuraLight PD, NeuraLight PSP and NeuraLight MSA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 10 Sep 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Oculometric Measures in the Differential Diagnosis of Typical and Atypical Parkinsonian Conditions: a Pilot Study
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.
Read the 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.
- Being tested
- NeuraLight PD, NeuraLight PSP, NeuraLight MSA, NeuraLight
- Medical subject headings
- Parkinson Disease, Supranuclear Palsy, Progressive, Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuraLight PDOther
NeuraLight software-based platform for PD patients
NeuraLight PSPOther
NeuraLight software-based platform for PSP patients
NeuraLight MSAOther
NeuraLight software-based platform for MSA patients
NeuraLightOther
NeuraLight software-based platform
| Study group | Role | What they receive |
|---|---|---|
| Parkinson patients | Active comparator | Patients diagnosed with Parkinson's disease, ages 50-80, Hoehn \& Yahr scale 1-3 Receives: Other: NeuraLight PD |
| PSP patients | Active comparator | Patients diagnosed with PSP, according to actual diagnostic criteria from Höglinger GU et al, 2017. Receives: Other: NeuraLight PSP |
| MSA patients | Active comparator | Patients diagnosed with MSA, according to actual diagnostic criteria from Wenning et al, 2022. Receives: Other: NeuraLight MSA |
| Healthy | Active comparator | Healthy subjects with no neurological diseases or cognition deficits Receives: Other: NeuraLight |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 12 months
Secondary outcomes (2)
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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Sep 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuraLight
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospitales Universitarios Virgen del Rocío
- Responsible party
- Sponsor
- Investigators
- Pablo Mir, MD, Principal investigator, IBIS (Instituto de Biomedicina de Sevilla), Calle Antonio Maura Montaner, Seville, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597071
- Sponsor's protocol ID
- NL/APD/2024-1
- Acronym
- PARATROOPER
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35501501
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Oculometric Measures in the Differential Diagnosis of Typical and Atypical Parkinsonian Conditions: a Pilot Study
- ClinicalTrials.gov ID
- NCT06597071
- Acronym / sponsor ID
- PARATROOPER / NL/APD/2024-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NeuraLightIndustry (pharma, biotech, devices)
- Collaborators
- Hospitales Universitarios Virgen del Rocío
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Parkinson patients | Active comparator | Other: NeuraLight PDPatients diagnosed with Parkinson's disease, ages 50-80, Hoehn \& Yahr scale 1-3 |
| PSP patients | Active comparator | Other: NeuraLight PSPPatients diagnosed with PSP, according to actual diagnostic criteria from Höglinger GU et al, 2017. |
| MSA patients | Active comparator | Other: NeuraLight MSAPatients diagnosed with MSA, according to actual diagnostic criteria from Wenning et al, 2022. |
| Healthy | Active comparator | Other: NeuraLightHealthy subjects with no neurological diseases or cognition deficits |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuraLight PDNeuraLight software-based platform for PD patients | Other | Parkinson patients |
| NeuraLight PSPNeuraLight software-based platform for PSP patients | Other | PSP patients |
| NeuraLight MSANeuraLight software-based platform for MSA patients | Other | MSA patients |
| NeuraLightNeuraLight software-based platform | Other | Healthy |
Primary outcome
Change of saccadic latency between subgroups
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Correlation between MDS-UPDRS score and its parts with saccadic latency
Time frame: 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
Time frame: 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)
Correlation between PSP-CDS and its parts with saccadic latency
Time frame: 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)
2 secondary outcomes
Correlation between MoCA score and its parts with anti-saccadic error rates
Time frame: 12 months
Correlation between MoCA score and its parts with smooth pursuit
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Background: PubMed 35501501Habibi 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Mir, MD principal investigator
IBIS (Instituto de Biomedicina de Sevilla), Calle Antonio Maura Montaner, Seville, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuraLight PD, NeuraLight PSP and NeuraLight MSA in people with Parkinson Disease and Progressive Supranuclear Palsy(PSP), run by NeuraLight at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of saccadic latency between subgroups (time frame: 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06597071, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.