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

Saccadous

Status: Completed

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

Treatments: Diagnostic Test: Complex eye movement exam

Study type: Observational

Funder types: Other

Identifiers

NCT04925622

SACCADOUSPDPH1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

90 participants in 3 patient groups

Control

Description:

No symptoms of neurological condition

Treatment:

Diagnostic Test: Complex eye movement exam

Parkinson's disease

Description:

Parkinson's disease diagnosis

Treatment:

Diagnostic Test: Complex eye movement exam

Non-PD Movement disorder

Description:

Non-PD with other movement disorder such as progressive supranuclear palsy, multiple system atrophy, essential tremor, corticobasal degeneration, vascular Parkinsonism, or Parkinsonian syndromes

Treatment:

Diagnostic Test: Complex eye movement exam