Patient-Centered PD Ambulatory Monitoring System

Parkinson Disease Clinical Trial

— ParkinPal  

Official title:

ParkinPal: Patient-Centered PD Ambulatory Monitoring System

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04142528
• Other study ID #: NR018128-01
• Secondary ID: 1R43NR018128-01
• Status: Enrolling by invitation
• Start date: July 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: October 2019
• Source: Great Lakes NeuroTechnologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• ParkinPal
Wear and periodic recording of motion data during daily wear

Locations

Country	Name	City	State
United States	David E. Riley, MD	Warrensville Heights	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Great Lakes NeuroTechnologies Inc.	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Useability	Following the study, patients will complete questionnaires on their experience with the wearable system.	6 weeks
Secondary	Symptom scores	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