Correlation of Motor Metrics and Neurological Data
- Conditions
- Movement Disorders (Incl Parkinsonism)
- Registration Number
- NCT05462080
- Lead Sponsor
- Ceraxis Health, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 29
Inclusion Criteria:<br><br> - Adult with a diagnosis of idiopathic Parkinson's disease or essential tremor by a<br> movement disorders neurologist<br><br> - Age greater than or equal to 21 years<br><br> - Hoehn and Yahr stage I-III<br><br> - Ability to ambulate 200+ meters independently<br><br> - Ability to follow 2-step commands<br><br> - Clinically responsive to medication or Deep Brain Stimulation (DBS)<br><br> - Clinically optimized medication or DBS for at least six months<br><br> - Able to tolerate withdrawal of medication and/or DBS<br><br>Exclusion Criteria:<br><br> - Any comorbidity which would exclude them from being able to use the Ceraxis product<br><br> - Inability to learn how to use the system<br><br> - Diagnosis of dementia or impairment that compromises the ability to provide informed<br> consent<br><br> - Neurological disease other than Parkinson's disease or essential tremor (i.e.<br> multiple sclerosis, stroke with residual motor deficits)<br><br> - Musculoskeletal injury that significantly alters gait
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method UPDRS-I, UPDRS-II, and UPDRS-III assessment for patients with Parkinson's disease;TETRAS tremor rating scale for patients with Essential Tremor;Upper extremities motor strength, assessed by neurological examination;Coordination test for the upper extremities to evaluate dysdiadochokinesia;Archimedes Spiral task;Freezing of Gait questionnaire;Usage Survey