COMMAND: Correlation of Motor Metrics and Neurological Data
Study Details
Study Description
Brief Summary
This is a pilot study to collect data with the Ceraxis product and standard movement disorders tests in order to prove and codify potential correlations.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Movement Disorders Patients
|
Diagnostic Test: Ceraxis product
All patients will have their symptoms evaluated using the Ceraxis product
|
Outcome Measures
Primary Outcome Measures
- Collection of data with Ceraxis product (stylus product with a built-in Inertial Measurement Unit (IMU) which includes a 3-axis accelerometer, gyroscope, and magnetometer, as well as a force sensing tip) [Day 1]
Patients will be guided through a set of actions while the sensors record movement data on their upper and lower extremity motor symptoms. This data will be correlated with the secondary outcome measures post hoc.
Secondary Outcome Measures
- UPDRS-I, UPDRS-II, and UPDRS-III assessment for patients with Parkinson's disease [Day 1]
- TETRAS tremor rating scale for patients with Essential Tremor [Day 1]
- Upper extremities motor strength, assessed by neurological examination [Day 1]
- Coordination test for the upper extremities to evaluate dysdiadochokinesia [Day 1]
- Archimedes Spiral task [Day 1]
- Freezing of Gait questionnaire [Day 1]
- Usage Survey [Day 1]
Custom survey given to patients to collect their impressions of the Ceraxis product
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult with a diagnosis of idiopathic Parkinson's disease or essential tremor by a movement disorders neurologist
-
Age greater than or equal to 21 years
-
Hoehn and Yahr stage I-III
-
Ability to ambulate 200+ meters independently
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Ability to follow 2-step commands
-
Clinically responsive to medication or Deep Brain Stimulation (DBS)
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Clinically optimized medication or DBS for at least six months
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Able to tolerate withdrawal of medication and/or DBS
Exclusion Criteria:
-
Any comorbidity which would exclude them from being able to use the Ceraxis product
-
Inability to learn how to use the system
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Diagnosis of dementia or impairment that compromises the ability to provide informed consent
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Neurological disease other than Parkinson's disease or essential tremor (i.e. multiple sclerosis, stroke with residual motor deficits)
-
Musculoskeletal injury that significantly alters gait
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- Ceraxis Health, Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REDD 0001