Patient-Centered PD Ambulatory Monitoring System

Great Lakes NeuroTechnologies Inc.20 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Parkinson Disease

Interventions

ParkinPalDEVICE

Wear and periodic recording of motion data during daily wear

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

David E. Riley, MD

Warrensville Heights, Ohio, United States

Outcomes

Primary Outcomes

Useability

Following the study, patients will complete questionnaires on their experience with the wearable system.

Time frame: 6 weeks

Secondary Outcomes

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.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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