Parkinson Disease Clinical Trial
Official title:
Complex Eye Movements in Parkinson's Disease and Related Movement Disorders
Verified date | May 2022 |
Source | Saccadous, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | April 15, 2022 |
Est. primary completion date | April 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Dignity Health / St. Joseph's Hospital and Medical Center | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Saccadous, Inc. | Barrow Neurological Institute, Dignity Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of patients accurately diagnosed with SaccadeDX | 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. |
One test (approx. 1 hour) |
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