Movement Disorders (Incl Parkinsonism)
Conditions
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.
Interventions
DIAGNOSTIC_TESTCeraxis product
All patients will have their symptoms evaluated using the Ceraxis product
Sponsors
Ceraxis Health, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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 * Ability to follow 2-step commands * Clinically responsive to medication or Deep Brain Stimulation (DBS) * Clinically optimized medication or DBS for at least six months * 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 * Diagnosis of dementia or impairment that compromises the ability to provide informed consent * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| UPDRS-I, UPDRS-II, and UPDRS-III assessment for patients with Parkinson's disease | 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 |
| Archimedes Spiral task | Day 1 | — |
Countries
United States
Outcome results
None listed