Correlation of Motor Metrics and Neurological Data

NCT ID: NCT05462080

Last Updated: 2024-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-10

Study Completion Date

2023-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Movement Disorders (Incl Parkinsonism)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Movement Disorders Patients

Ceraxis product

Intervention Type DIAGNOSTIC_TEST

All patients will have their symptoms evaluated using the Ceraxis product

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ceraxis product

All patients will have their symptoms evaluated using the Ceraxis product

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ceraxis Health, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REDD 0001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Proprioception and Meditation
NCT03079817 COMPLETED NA
Chinese Exercise Modalities in Parkinson's Disease
NCT00029809 COMPLETED PHASE1/PHASE2