Correlation of Motor Metrics and Neurological Data | NCT05462080

Studies
Correlation of Motor Metrics and Neurological Data

NCT05462080

Sponsor

Ceraxis Health, Inc

Status

Completed

Last Update Posted

Aug 20, 2024Actual

Enrollment

29Actual

Phase

Not provided

Conditions

Movement Disorders (Incl Parkinsonism)

Interventions

Ceraxis product

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2022Actual

Primary Completion Date

Aug 31, 2023Actual

Completion Date

Aug 31, 2023Actual

First Submitted Date

Jul 6, 2022

First Submission Date that Met QC Criteria

Jul 13, 2022

First Posted Date

Jul 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2024

Last Update Posted Date

Aug 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Movement Disorders Patients			Diagnostic Test: Ceraxis product

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ceraxis product	Diagnostic Test	All patients will have their symptoms evaluated using the Ceraxis product	Movement Disorders Patients

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Movement disorders patients being treated at the site

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic Foundation		Cleveland	Ohio	44195	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009069	Movement Disorders

Ancestor Terms

ID	Term
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided