Clinical trial NCT04925622: Complex Eye Movements in Parkinson's Disease and Related Movement Disorders
Official title: Complex Eye Movements in Parkinson's Disease and Related Movement Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Saccadous, Inc.
Sponsor class: OTHER
Collaborators: name: Dignity Health
name: Barrow Neurological Institute
First posted: 2021-06-14
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of patients accurately diagnosed with SaccadeDX
timeFrame: One test (approx. 1 hour)
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Dignity Health / St. Joseph's Hospital and Medical Center
state: Arizona
Study officials:
affiliation: Saccadous Chief Technology Officer
name: Hector Rieiro, PhD
role: PRINCIPAL_INVESTIGATOR
References: