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

Completed

• Conditions: Progressive Supranuclear Palsy; Essential Tremor; Multiple System Atrophy, Parkinson Variant; Parkinsonian Syndrome; Corticobasal Degeneration; Parkinsonian Disorders; Huntington Disease; Parkinson's Disease and Parkinsonism; Parkinson Disease; Vascular Parkinsonism
• Interventions: Diagnostic Test: Complex eye movement exam

• Registration Number: NCT04925622
• Lead Sponsor: Saccadous, Inc.

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.

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 Timeline

• Study Start: 2021-01-04
• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-07
• Study First Posted: 2021-06-14
• Primary Completion: 2022-04-15
• Study Completion: 2022-04-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Complex eye movement exam	No symptoms of neurological condition
Parkinson's disease	Complex eye movement exam	Parkinson's disease diagnosis
Non-PD Movement disorder	Complex eye movement exam	Non-PD with other movement disorder such as progressive supranuclear palsy, multiple system atrophy, essential tremor, corticobasal degeneration, vascular Parkinsonism, or Parkinsonian syndromes

Primary Outcome Measures

Name	Time	Method
Percent of patients accurately diagnosed with SaccadeDX	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.

Trial Locations

Locations (1)

Dignity Health / St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States