Parkinson DiseaseNCT04925622
Complex Eye Movements in Parkinson's Disease and Related Movement Disorders
An observational study of Parkinson Disease and Parkinson's Disease and Parkinsonism, run by Saccadous, Inc. at 1 site in United States.
Trial summary
Diagnosing Parkinson's disease (PD) depends on the clinical history of the patient and the patient's response to specific treatments such as levodopa. Unfortunately, a definitive diagnosis of PD is still limited to post-mortem evaluation of brain tissues. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Parkinson's Disease and Parkinsonism, Progressive Supranuclear Palsy
- What is being tested?
- Complex eye movement exam
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 15 Apr 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community Sample
Who may be able to join
- Patients assigned to PD or non-PD group based on medical records
- Control participants will be without previous diagnosis of a movement disorder
- Experimental groups and normal controls matched by age and gender
Who cannot join
- Severe drug/alcohol use
- Severe medical problems (e.g. terminal cancer)
- Macular degeneration
- Inability to consent
- Patients at 4 or more on the Hoehn-Yahr scale
- Inability to complete experimental protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Dignity Health / St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
About this study
Diagnosing Parkinson's disease (PD) depends on the clinical history of the patient and the patient's response to specific treatments such as levodopa. Unfortunately, a definitive diagnosis of PD is still limited to post-mortem evaluation of brain tissues. Furthermore, diagnosis of idiopathic PD is even more challenging because symptoms of PD overlap with symptoms of other conditions such as essential tremor (ET) or Parkinsonian syndromes (PSs) such as progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal degeneration (CBD), or vascular Parkinsonism (VaP). Based on the principle that PD and PSs affect brain areas involved in eye movement control, this trial will utilize a platform that records complex eye movements and use a proprietary algorithm to characterize PSs. Preliminary data demonstrate that by monitoring oculomotor alterations, the process can assign PD-specific oculomotor patterns, which have the potential to serve as a diagnostic tool for PD.
This study will evaluate capabilities of the process and its ability to differentiate PD from other PSs with statistical significance. The specific aims of this proposal are: To optimize the detection and analysis algorithms, and then to evaluate the process against neurological diagnoses of PD patients in a clinical study.
Read the detailed description
In the Phase I, complex eye movements, including Fixation, Optokinetic Nystagmus (OKN), Guided Saccades, Microsaccades, Smooth Pursuit, and Pupillometry will be measured in 90 subjects (30 PD, 30 non-PD with other movement disorders (PSP, ET, CBD, etc.), and 30 normal defined as not having any symptoms of any neurological condition.) The patients will be classified according to clinical evaluations and clinical follow ups performed by Dr. Holly Shill, Director of the Lonnie and Muhammad Ali Parkinson Center at the Barrow Neurological Institute (Phoenix, AZ). A 3-way analysis will be performed to troubleshoot and optimize the detection and classification algorithms. At this stage, these results will only be used for the evaluation of the diagnostic capability of the tool and not to treat or diagnose the patient. The product is portable with the potential to be an accurate tool to diagnose PD. This tool will provide substantial support to neurologists by validating or complementing the clinical tests currently used to diagnose PD. Successful diagnosis of PD can open new avenues for diagnosing other neurological conditions.
- Conditions
- Parkinson Disease, Parkinson's Disease and Parkinsonism, Progressive Supranuclear Palsy, Corticobasal Degeneration, Parkinsonian Disorders, Essential Tremor
- Being tested
- Complex eye movement exam
- Keywords
- Eye Movement, Neurological Diagnosis, Saccades, Microsaccades
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Supranuclear Palsy, Progressive, Corticobasal Degeneration, Essential Tremor, Multiple System Atrophy, Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex eye movement examDiagnostic test
Subjects will undergo a complex eye exam which will capture fixation, optokinetic nystagmus, guided saccades, microsaccades, smooth pursuit, and pupillometry.
Eye tracking equipment will be set and calibrated to the participant who will then perform the full 10 minute testing protocol with instructions from the investigator. After this, they will take a five minute break. The oculomotor testing protocol will be repeated twice.
| Study group | Role | What they receive |
|---|---|---|
| Control | No symptoms of neurological condition Receives: Diagnostic Test: Complex eye movement exam | |
| Parkinson's disease | Parkinson's disease diagnosis Receives: Diagnostic Test: Complex eye movement exam | |
| Non-PD Movement disorder | Non-PD with other movement disorder such as progressive supranuclear palsy, multiple system atrophy, essential tremor, corticobasal degeneration, vascular Parkinsonism, or Parkinsonian syndromes Receives: Diagnostic Test: Complex eye movement exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients accurately diagnosed with SaccadeDX
The primary outcome measure will be accurate diagnosis in over 75% of patients; accuracy will be determined with statistical significance.
Each eye movement test will produce a unique signature. Using a historical database and machine learning, the SaccadeDX algorithm will match the signature to a specific patient group (PD, non-PD movement disorder, control) resulting in a "SaccadeDX diagnosis". Once the patients are fully enrolled, the SaccadeDX diagnosis will be compared to the diagnosis previously made by the sub-investigator. Accurate diagnosis will be defined as a SaccadeDX diagnosis that matches the initial diagnosis provided by the sub-investigator.
Measured: One test (approx. 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start4 Jan 2021
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Saccadous, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Dignity Health, Barrow Neurological Institute
- Responsible party
- Sponsor
- Investigators
- Hector Rieiro, PhD, Principal investigator, Saccadous Chief Technology Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925622
- Sponsor's protocol ID
- SACCADOUSPDPH1
- Status last verified
- May 2022
- First submitted
- 1 Jun 2021
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Proprietary and competitive data
Publications
Menke JM, Aslam S, Rieiro H, Waldorf R, Shill HA. Automated eye-tracking for Parkinson's disease diagnosis: a proof-of-concept cascade classifier study. Clin Park Relat Disord. 2026 Oct 2;15:100509. doi: 10.1016/j.prdoa.2026.100509. eCollection 2026.
PubMed 42876454
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Eye Movements in Parkinson's Disease and Related Movement Disorders
- ClinicalTrials.gov ID
- NCT04925622
- Acronym / sponsor ID
- SACCADOUSPDPH1
- Conditions
- Parkinson Disease, Parkinson's Disease and Parkinsonism, Progressive Supranuclear Palsy, Corticobasal Degeneration, Parkinsonian Disorders, Essential Tremor
- Keywords
- Eye Movement, Neurological Diagnosis, Saccades, Microsaccades
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Saccadous, Inc.University, hospital or other
- Collaborators
- Dignity Health, Barrow Neurological Institute
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 14 Jun 2021 (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.
Diagnosing Parkinson's disease (PD) depends on the clinical history of the patient and the patient's response to specific treatments such as levodopa. Unfortunately, a definitive diagnosis of PD is still limited to post-mortem evaluation of brain tissues. Furthermore, diagnosis of idiopathic PD is even more challenging because symptoms of PD overlap with symptoms of other conditions such as essential tremor (ET) or Parkinsonian syndromes (PSs) such as progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal degeneration (CBD), or vascular Parkinsonism (VaP). Based on the principle that PD and PSs affect brain areas involved in eye movement control, this trial will utilize a platform that records complex eye movements and use a proprietary algorithm to characterize PSs. Preliminary data demonstrate that by monitoring oculomotor alterations, the process can assign PD-specific oculomotor patterns, which have the potential to serve as a diagnostic tool for PD.
This study will evaluate capabilities of the process and its ability to differentiate PD from other PSs with statistical significance. The specific aims of this proposal are: To optimize the detection and analysis algorithms, and then to evaluate the process against neurological diagnoses of PD patients in a clinical study.
Detailed description
In the Phase I, complex eye movements, including Fixation, Optokinetic Nystagmus (OKN), Guided Saccades, Microsaccades, Smooth Pursuit, and Pupillometry will be measured in 90 subjects (30 PD, 30 non-PD with other movement disorders (PSP, ET, CBD, etc.), and 30 normal defined as not having any symptoms of any neurological condition.) The patients will be classified according to clinical evaluations and clinical follow ups performed by Dr. Holly Shill, Director of the Lonnie and Muhammad Ali Parkinson Center at the Barrow Neurological Institute (Phoenix, AZ). A 3-way analysis will be performed to troubleshoot and optimize the detection and classification algorithms. At this stage, these results will only be used for the evaluation of the diagnostic capability of the tool and not to treat or diagnose the patient. The product is portable with the potential to be an accurate tool to diagnose PD. This tool will provide substantial support to neurologists by validating or complementing the clinical tests currently used to diagnose PD. Successful diagnosis of PD can open new avenues for diagnosing other neurological conditions.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: Complex eye movement examNo symptoms of neurological condition |
| Parkinson's disease | – | Diagnostic Test: Complex eye movement examParkinson's disease diagnosis |
| Non-PD Movement disorder | – | Diagnostic Test: Complex eye movement examNon-PD with other movement disorder such as progressive supranuclear palsy, multiple system atrophy, essential tremor, corticobasal degeneration, vascular Parkinsonism, or Parkinsonian syndromes |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community Sample
Key inclusion criteria (3 listed)
- Patients assigned to PD or non-PD group based on medical records
- Control participants will be without previous diagnosis of a movement disorder
- Experimental groups and normal controls matched by age and gender
Key exclusion criteria (6 listed)
- Severe drug/alcohol use
- Severe medical problems (e.g. terminal cancer)
- Macular degeneration
- Inability to consent
- Patients at 4 or more on the Hoehn-Yahr scale
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 |
|---|---|---|
| Complex eye movement examSubjects will undergo a complex eye exam which will capture fixation, optokinetic nystagmus, guided saccades, microsaccades, smooth pursuit, and pupillometry. Eye tracking equipment will be set and calibrated to the participant who will then perform the full 10 minute testing protocol with instructions from the investigator. After this, they will take a five minute break. The oculomotor testing protocol will be repeated twice. | Diagnostic test | Control, Non-PD Movement disorder, Parkinson's disease |
Primary outcome
Percent of patients accurately diagnosed with SaccadeDX
Time frame: One test (approx. 1 hour)
The primary outcome measure will be accurate diagnosis in over 75% of patients; accuracy will be determined with statistical significance. Each eye movement test will produce a unique signature. Using a historical database and machine learning, the SaccadeDX algorithm will match the signature to a specific patient group (PD, non-PD movement disorder, control) resulting in a "SaccadeDX diagnosis". Once the patients are fully enrolled, the SaccadeDX diagnosis will be compared to the diagnosis previously made by the sub-investigator. Accurate diagnosis will be defined as a SaccadeDX diagnosis that matches the initial diagnosis provided by the sub-investigator.
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 4 May 2022.
- Derived from this study: PubMed 42876454Menke JM, Aslam S, Rieiro H, Waldorf R, Shill HA. Automated eye-tracking for Parkinson's disease diagnosis: a proof-of-concept cascade classifier study. Clin Park Relat Disord. 2026 Oct 2;15:100509. doi: 10.1016/j.prdoa.2026.100509. eCollection 2026.
- Individual participant dataSharing planned: No. Proprietary and competitive data
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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.
Hector Rieiro, PhD principal investigator
Saccadous Chief Technology Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Parkinson's Disease and Parkinsonism, run by Saccadous, Inc. at 1 site in United States.
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 3 inclusion and 6 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 4 May 2022. 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 United States. 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?
Percent of patients accurately diagnosed with SaccadeDX (time frame: One test (approx. 1 hour)). 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 NCT04925622, 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 4 May 2022.