Correlation of Motor Metrics and Neurological Data (COMMAND)

Correlation of Motor Metrics and Neurological Data (COMMAND)

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.

Study Overview

• Status: Completed
• Conditions: Movement Disorders (Incl Parkinsonism)
• Intervention / Treatment: Diagnostic test: Ceraxis product

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Movement disorders patients being treated at the site

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Movement Disorders Patients	Diagnostic test: Ceraxis product; All patients will have their symptoms evaluated using the Ceraxis product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Custom survey given to patients to collect their impressions of the Ceraxis product	Day 1

Collaborators and Investigators

• Sponsor: Ceraxis Health, Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Parkinsonian Disorders
• Other Study ID Numbers: REDD 0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No