Parkinson DiseaseNCT05795023
A Longitudinal Evaluation of Oculometric Measures and Clinical Assessment Over Time in PD Patients
A study testing NeuraLight in people with Parkinson Disease, run by NeuraLight at 1 site in Israel.
Trial summary
This is a prospective study in a cohort of about 30 patients with Idiopathic Parkinson's disease, who will be evaluated with a clinical assessment and an oculometric examination during a time period with specific intervals. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- NeuraLight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 8 May 2023to 28 Oct 2024
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with idiopathic PD (Hoehn \& Yahr scale 1-3)
- Age between 18 and 85 years old
- Normal or corrected vision
- Ability to follow instructions
- Willing and able to sign an informed consent form
Who cannot join
- Inability to sit for 30 minutes on a chair in a calm manner
- Personal or 1st degree relative history of epilepsy
- Additional neurological diseases
- Drug or alcohol abuse (except for using medical cannabis during 24 hours prior NL examination date)
- Pregnancy or a potential pregnancy (self-declaration)
Trial locations and contacts
1 site in 1 country.
Israel1 site
Movement Disorders Unit, Sourasky Tel Aviv Medical Center
Tel Aviv, 6423906
About this study
Official title: A Longitudinal Study to Evaluate the Correlation Between Oculometric Measures and MDS-UPDRS Over Time in a Cohort of Patients With Idiopathic Parkinson's Disease (PD)
This is a prospective study in a cohort of about 30 patients with Idiopathic Parkinson's disease, who will be evaluated with a clinical assessment and an oculometric examination during a time period with specific intervals.
This study aims to evaluate the correlation between oculometric measures and clinical assessment over time.
Read the detailed description
This is an observational prospective cohort study, in a cohort of up to 30 patients with idiopathic PD. The aim of this study is to demonstrate that oculometric measures are able to detect patient deterioration faster than can be detected using the currently available clinical assessment tools. In addition, to evaluate the correlation between oculometric measures and Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score over time ,in subjects who meet the inclusion and exclusion criteria, and who provide a signed Informed Consent. All patients will be assessed using MDS-UPDRS over a period of 9 months (4 assessments, at 0, 3, 6, 9 months). During this time period, every subject who consents will undergo 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) (approx. 30 minutes). The oculometric evaluation will occur during the first 3 months for every patient every 2 weeks (+3 days), and then after 6 months and 9 months from enrollment (+3 days), (9 tests in total). All assessments will be performed during a clinic visit unless authorized to be conducted remotely. During the study, the sponsor will be blinded to the private details of the subjects.
- Conditions
- Parkinson Disease
- Being tested
- NeuraLight
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuraLightOther
NeuraLight software-based platform
| Study group | Role | What they receive |
|---|---|---|
| PD patients | Experimental | Men and women with idiopathic PD (Hoehn \& Yahr scale 1-3) aged 18-85 years Receives: Other: NeuraLight |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 anti-saccadic error rates over time as evaluated during visits
Difference between anti-saccadic error rates (%) 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 smooth pursuit speed over time as evaluated during visits
Difference between smooth pursuit speed (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
Correlation between MDS-UPDRS score and its parts with saccadic latency
The correlation between MDS-UPDRS score 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) according to the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at visits
Measured: 12 months
Correlation between MDS-UPDRS score and its parts with anti-saccadic error rates
The correlation between MDS-UPDRS score and its parts 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 Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at visits
Measured: 12 months
Correlation between MDS-UPDRS score and its parts with smooth pursuit
The correlation between MDS-UPDRS score and its parts 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 Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at visits
Measured: 12 months
Secondary outcomes (1)
Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MDS-UPDRS clinical endpoint
Optimization of a feature selection model (Fisher's Linear Discriminant Analysis (LDA)) on NeuraLight oculometric measures used for a logistic regression model of MDS-UPDRS with a relative root mean square error (RMSE) of <0.1
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 posted3 Apr 2023
- Study start8 May 2023
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will be assessed with MDS-UPDRS and oculometric examination over time
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuraLight
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tanya Gurevich, MD, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795023
- Sponsor's protocol ID
- NL/PD/2022-3
- Status last verified
- Oct 2024
- First submitted
- 6 Mar 2023
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study to Evaluate the Correlation Between Oculometric Measures and MDS-UPDRS Over Time in a Cohort of Patients With Idiopathic Parkinson's Disease (PD)
- ClinicalTrials.gov ID
- NCT05795023
- Acronym / sponsor ID
- NL/PD/2022-3
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NeuraLightIndustry (pharma, biotech, devices)
- Study start
- 8 May 2023 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 3 Apr 2023 (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 a prospective study in a cohort of about 30 patients with Idiopathic Parkinson's disease, who will be evaluated with a clinical assessment and an oculometric examination during a time period with specific intervals.
This study aims to evaluate the correlation between oculometric measures and clinical assessment over time.
Detailed description
This is an observational prospective cohort study, in a cohort of up to 30 patients with idiopathic PD. The aim of this study is to demonstrate that oculometric measures are able to detect patient deterioration faster than can be detected using the currently available clinical assessment tools. In addition, to evaluate the correlation between oculometric measures and Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score over time ,in subjects who meet the inclusion and exclusion criteria, and who provide a signed Informed Consent. All patients will be assessed using MDS-UPDRS over a period of 9 months (4 assessments, at 0, 3, 6, 9 months). During this time period, every subject who consents will undergo 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) (approx. 30 minutes). The oculometric evaluation will occur during the first 3 months for every patient every 2 weeks (+3 days), and then after 6 months and 9 months from enrollment (+3 days), (9 tests in total). All assessments will be performed during a clinic visit unless authorized to be conducted remotely. During the study, the sponsor will be blinded to the private details of the subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will be assessed with MDS-UPDRS and oculometric examination over time
| Arm | Type | Receives |
|---|---|---|
| PD patients | Experimental | Other: NeuraLightMen and women with idiopathic PD (Hoehn \& Yahr scale 1-3) aged 18-85 years |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women with idiopathic PD (Hoehn \& Yahr scale 1-3)
- Age between 18 and 85 years old
- Normal or corrected vision
- Ability to follow instructions
- Willing and able to sign an informed consent form
Key exclusion criteria (5 listed)
- Inability to sit for 30 minutes on a chair in a calm manner
- Personal or 1st degree relative history of epilepsy
- Additional neurological diseases
- Drug or alcohol abuse (except for using medical cannabis during 24 hours prior NL examination date)
- Pregnancy or a potential pregnancy (self-declaration)
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 |
|---|---|---|
| NeuraLightNeuraLight software-based platform | Other | PD patients |
Primary outcome
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 anti-saccadic error rates over time as evaluated during visits
Time frame: 12 months
Difference between anti-saccadic error rates (%) 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 smooth pursuit speed over time as evaluated during visits
Time frame: 12 months
Difference between smooth pursuit speed (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
Correlation between MDS-UPDRS score and its parts with saccadic latency
Time frame: 12 months
The correlation between MDS-UPDRS score 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) according to the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at visits
Correlation between MDS-UPDRS score and its parts with anti-saccadic error rates
Time frame: 12 months
The correlation between MDS-UPDRS score and its parts 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 Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at visits
Correlation between MDS-UPDRS score and its parts with smooth pursuit
Time frame: 12 months
The correlation between MDS-UPDRS score and its parts 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 Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at visits
1 secondary outcome
Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of MDS-UPDRS clinical endpoint
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Tanya Gurevich, MD principal investigator
Tel Aviv Medical Center
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 in people with Parkinson Disease, run by NeuraLight at 1 site in Israel.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 29 Oct 2024. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 over time as evaluated during visits (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2024.