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

NCT04925622 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2022-05-04

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Complex eye movement exam

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.

Sponsors & Collaborators

  • Dignity Health

    collaborator OTHER
  • Barrow Neurological Institute

    collaborator OTHER
  • Saccadous, Inc.

    lead OTHER

Principal Investigators

  • Hector Rieiro, PhD · Saccadous Chief Technology Officer

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-04
Primary Completion
2022-04-15
Completion
2022-04-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04925622 on ClinicalTrials.gov