Correlation of Motor Metrics and Neurological Data

Completed

• Conditions: Movement Disorders (Incl Parkinsonism)
• Interventions: Diagnostic Test: Ceraxis product

• Registration Number: NCT05462080
• Lead Sponsor: Ceraxis Health, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-18
• Study Start: 2022-11-10
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Movement Disorders Patients	Ceraxis product	-

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)	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 Outcome Measures

Name	Time	Method
Freezing of Gait questionnaire	Day 1
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
Coordination test for the upper extremities to evaluate dysdiadochokinesia	Day 1
Usage Survey	Day 1	Custom survey given to patients to collect their impressions of the Ceraxis product

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States