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

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Brief Title

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

Official Title

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

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 Type

Observational [Patient Registry]


Primary Outcome

Percent of patients accurately diagnosed with SaccadeDX


Condition

Parkinson Disease

Intervention

Complex eye movement exam

Study Arms / Comparison Groups

 Control
Description:  No symptoms of neurological condition

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

90

Start Date

January 4, 2021

Completion Date

August 31, 2021

Primary Completion Date

August 31, 2021

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
      

Gender

All

Ages

30 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Hector Rieiro, PhD, 314-322-8616, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04925622

Organization ID

SACCADOUSPDPH1


Responsible Party

Sponsor

Study Sponsor

Saccadous, Inc.

Collaborators

 Dignity Health

Study Sponsor

Hector Rieiro, PhD, Principal Investigator, Saccadous Chief Technology Officer


Verification Date

June 2021