Patient-Centered PD Ambulatory Monitoring System

• Conditions: Parkinson Disease
• Interventions: Device: ParkinPal

• Registration Number: NCT04142528
• Lead Sponsor: Great Lakes NeuroTechnologies Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-10-25
• Last Update Submitted: 2019-10-25
• Study First Posted: 2019-10-29
• Last Update Posted: 2019-10-29
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinson's Disease	ParkinPal	Smartwatch-based sensor assessment of PD symptoms during standard care

Primary Outcome Measures

Name	Time	Method
Useability	6 weeks	Following the study, patients will complete questionnaires on their experience with the wearable system.

Secondary Outcome Measures

Name	Time	Method
Symptom scores	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.

Trial Locations

Locations (1)

David E. Riley, MD; 🇺🇸 Warrensville Heights, Ohio, United States