Correlation of Motor Metrics and Neurological Data

NCT05462080 | Completed

• 1 other identifier: REDD 0001
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Movement Disorders (Incl Parkinsonism)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (1)

Movement Disorders Patients

Diagnostic Test: Ceraxis product

Interventions

Ceraxis product DIAGNOSTIC_TEST

All patients will have their symptoms evaluated using the Ceraxis product

Movement Disorders Patients

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Movement disorders patients being treated at the site

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ceraxis Health, Inc: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 18, 2022
• Study Start: November 10, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

US (1)