Correlation of Motor Metrics and Neurological Data (COMMAND)

Ceraxis Health, Inc1 site in 1 country29 target enrollmentNovember 10, 2022

ConditionsMovement Disorders (Incl Parkinsonism)

Overview

Phase: N/A
Intervention: Not specified
Conditions: Movement Disorders (Incl Parkinsonism)
Sponsor: Ceraxis Health, Inc
Enrollment: 29
Locations: 1
Primary Endpoint: 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)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 10, 2022

End Date

August 31, 2023

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Ceraxis Health, Inc

Responsible Party

Sponsor

Eligibility 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
•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

Outcomes

Primary Outcomes

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)

Time Frame: 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 Outcomes

Archimedes Spiral task(Day 1)
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)
Freezing of Gait questionnaire(Day 1)
Coordination test for the upper extremities to evaluate dysdiadochokinesia(Day 1)
Usage Survey(Day 1)