Patient-Centered PD Ambulatory Monitoring System (ParkinPal)

October 25, 2019 updated by: Great Lakes NeuroTechnologies Inc.

ParkinPal: Patient-Centered PD Ambulatory Monitoring System

This a usability study of a wearable sensor platform that utilizes a smartwatch to periodically record motion data. That data is processed in a connected smartphone and translated into symptom scores for dyskinesia, slowness, and tremor. The research subjects will use the wearable system over the course of five weeks, during which a change in therapy regimen is prescribed by the physician. Research analysis will be focused on patient and clinician experiences with the app and its reports.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

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
    • Ohio
      • Warrensville Heights, Ohio, United States, 44128
        • David E. Riley, MD

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

Non-Probability Sample

Study Population

The population is people with Parkinson's Disease who are patients of David E. Riley, MD. Therefore most participants will reside in the northeast Ohio area.

Description

Inclusion Criteria:

  • Existing Patient of Collaborating Physician (David E. Riley, MD)
  • Diagnosed With Parkinson's Disease
  • Hoehn & Yahr Scale I-III
  • Ambulatory and capable of using the ParkinPal system
  • Able to understand and follow instructions regarding using the device

Exclusion Criteria:

  • Any subject that does not meet the subject selection criteria will be excluded from this study. Children will be excluded from this study due to the fact that they are unlikely to have PD. Subjects that are not capable of functioning independently or are so symptomatic as to compromise their safety will also be excluded.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parkinson's Disease
Smartwatch-based sensor assessment of PD symptoms during standard care
Device: ParkinPal
Wear and periodic recording of motion data during daily wear
Other Names:
  • KinesiaU motor assessment system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Useability
Time Frame: 6 weeks
Following the study, patients will complete questionnaires on their experience with the wearable system.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom scores
Time Frame: 6 weeks
The recorded scores will be and timing of medication and exercise diary entries will be examined to measure the effect of therapy and therapy regimen change on symptom scores.
6 weeks

Collaborators and Investigators

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

Sponsor

Great Lakes NeuroTechnologies Inc.

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Dustin Heldman, PhD, Great Lakes NeuroTechnologies

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)

July 1, 2019

Primary Completion (Anticipated)

June 30, 2020

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

October 25, 2019

First Submitted That Met QC Criteria

October 25, 2019

First Posted (Actual)

October 29, 2019

Study Record Updates

Last Update Posted (Actual)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NR018128-01
  • 1R43NR018128-01 (U.S. NIH Grant/Contract)

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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