Monitoring Movement Disorder Symptoms With a Mobile Medical App on Off-the-shelf Consumer Mobile Devices

December 27, 2022 updated by: Parkinson's & Movement Disorders Center of Maryland
The purpose of this study is to evaluate whether New Touch Digital (NTD) NeuroRPM software installed on wearable devices can objectively measure and track symptoms in patients with Parkinson's disease.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Elkridge, Maryland, United States, 21075
        • Parkinson's & Movement Disorders Center of Maryland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study is open to persons 18 years of age and older with a clinical diagnosis of Parkinson's diseases without other neurological diseases.

Description

Inclusion Criteria:

  1. Subject is 18 years of age or older
  2. Subject is able to provide informed written consent
  3. Subject has been clinically diagnosed with Parkinson's Disease
  4. Subject is mentally and physically capable of performing tasks on the mobile device and related physical activities herein described

Exclusion Criteria:

  1. Inability to give informed consent
  2. Presence of additional neurological disease aside from the diseases being studied
  3. Inability to understand and follow the directions for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parkinson's patients
Cohort of patients with clinical diagnosis of Parkinson's diseases with varied symptoms and severity.
Device: Monitoring Device
Monitoring Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NeuroRPM UPDRS predicted score vs. clinical raters' UPDRS
Time Frame: Comparison will be performed upon completion of the study, approximately in 1 year.
We will compare symptom severity as predicted by NeuroRPM to UPDRS scores from clinical raters. Statistical significance will be evaluated by intraclass correlation and kappa-statistic.
Comparison will be performed upon completion of the study, approximately in 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parkinson's & Movement Disorders Center of Maryland

Collaborators

New Touch Digital Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2019

Primary Completion (Actual)

June 1, 2020

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

June 21, 2022

First Submitted That Met QC Criteria

December 27, 2022

First Posted (Estimate)

January 11, 2023

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

December 27, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTD-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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