Complex Eye Movements in Parkinson's Disease and Related Movement Disorders

NCT04925622 | Completed FDA Device

• 1 other identifier: SACCADOUSPDPH1
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Parkinson Disease; Parkinson's Disease and Parkinsonism; Progressive Supranuclear Palsy; Corticobasal Degeneration; Parkinsonian Disorders; Essential Tremor; Vascular Parkinsonism; Multiple System Atrophy, Parkinson Variant; Parkinsonian Syndrome; Huntington Disease

Keywords

Eye Movement; Neurological Diagnosis; Saccades; Microsaccades

Outcome Measures

Primary Outcomes (1)

• 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.

  One test (approx. 1 hour)

Study Arms (3)

Control

No symptoms of neurological condition

Diagnostic Test: Complex eye movement exam

Parkinson's disease

Parkinson's disease diagnosis

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

Diagnostic Test: Complex eye movement exam

Interventions

Complex eye movement exam DIAGNOSTIC_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.

Control; Non-PD Movement disorder; Parkinson's disease

Eligibility Criteria

• Age: 30 Years+
• Gender Eligibility Details: Both male and females eligible; control group will be age and gender matched
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community Sample

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saccadous, Inc.: lead
• Dignity Health: collaborator
• Barrow Neurological Institute: collaborator

Study Sites (1)

Dignity Health / St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Supranuclear Palsy, Progressive; Corticobasal Degeneration; Essential Tremor; Multiple System Atrophy; Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Primary Dysautonomias; Autonomic Nervous System Diseases; Dementia; Chorea; Dyskinesias; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Hector Rieiro, PhD

  Saccadous Chief Technology Officer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 14, 2021
• Study Start: January 4, 2021
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)