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Patient-Centered PD Ambulatory Monitoring System (ParkinPal)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04142528
Recruitment Status : Enrolling by invitation
First Posted : October 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Parkinson Disease Device: ParkinPal

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: ParkinPal: Patient-Centered PD Ambulatory Monitoring System
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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 Name: KinesiaU motor assessment system




Primary Outcome Measures :
  1. Useability [ Time Frame: 6 weeks ]
    Following the study, patients will complete questionnaires on their experience with the wearable system.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04142528


Locations
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United States, Ohio
David E. Riley, MD
Warrensville Heights, Ohio, United States, 44128
Sponsors and Collaborators
Great Lakes NeuroTechnologies Inc.
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Dustin Heldman, PhD Great Lakes NeuroTechnologies

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Responsible Party: Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier: NCT04142528    
Other Study ID Numbers: NR018128-01
1R43NR018128-01 ( U.S. NIH Grant/Contract )
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019

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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
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases