Correlation of Motor Metrics and Neurological Data

N/ACompletedNCT05462080

Ceraxis Health, Inc29 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Movement Disorders (Incl Parkinsonism)

Interventions

Ceraxis productDIAGNOSTIC_TEST

All patients will have their symptoms evaluated using the Ceraxis product

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: Day 1

Secondary Outcomes

UPDRS-I, UPDRS-II, and UPDRS-III assessment for patients with Parkinson's disease

Time frame: Day 1

TETRAS tremor rating scale for patients with Essential Tremor

Time frame: Day 1

Upper extremities motor strength, assessed by neurological examination

Time frame: Day 1

Coordination test for the upper extremities to evaluate dysdiadochokinesia

Time frame: Day 1

Archimedes Spiral task

Time frame: Day 1

Freezing of Gait questionnaire

Time frame: Day 1

Usage Survey

Custom survey given to patients to collect their impressions of the Ceraxis product

Time frame: Day 1

Data from ClinicalTrials.gov

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