Skip to main content
OpenTrials
Completed

NCT Number: NCT05462080

Correlation of Motor Metrics and Neurological Data

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Movement Disorders (Incl Parkinsonism) Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ceraxis product

Diagnostic Test

All patients will have their symptoms evaluated using the Ceraxis product

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)

    Time frame: 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 outcomes

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

    Time frame: Day 1

  2. TETRAS tremor rating scale for patients with Essential Tremor

    Time frame: Day 1

  3. Upper extremities motor strength, assessed by neurological examination

    Time frame: Day 1

  4. Coordination test for the upper extremities to evaluate dysdiadochokinesia

    Time frame: Day 1

  5. Archimedes Spiral task

    Time frame: Day 1

  6. Freezing of Gait questionnaire

    Time frame: Day 1

  7. Usage Survey

    Time frame: Day 1

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

Sponsors and collaborators

Lead sponsor

Ceraxis Health, Inc

Industry

Registry information

Official study title

Correlation of Motor Metrics and Neurological Data (COMMAND)

Acronym: COMMAND

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2022
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.