Correlation of Motor Metrics and Neurological Data

Movement Disorders (Incl Parkinsonism) Clinical Trial

— COMMAND  

Official title:

Correlation of Motor Metrics and Neurological Data (COMMAND)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05462080
• Other study ID #: REDD 0001
• Status: Recruiting
• Start date: November 10, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: February 2023
• Source: Ceraxis Health, Inc
• Contact: Stuart Holtham
• Phone: 2164455637
• Email: houlths[@]ccf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Movement Disorders
• Movement Disorders (Incl Parkinsonism)
• Parkinsonian Disorders

Intervention

Diagnostic Test:
• Ceraxis product
All patients will have their symptoms evaluated using the Ceraxis product

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ceraxis Health, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	UPDRS-I, UPDRS-II, and UPDRS-III assessment for patients with Parkinson's disease		Day 1
Secondary	TETRAS tremor rating scale for patients with Essential Tremor		Day 1
Secondary	Upper extremities motor strength, assessed by neurological examination		Day 1
Secondary	Coordination test for the upper extremities to evaluate dysdiadochokinesia		Day 1
Secondary	Archimedes Spiral task		Day 1
Secondary	Freezing of Gait questionnaire		Day 1
Secondary	Usage Survey	Custom survey given to patients to collect their impressions of the Ceraxis product	Day 1