Patient-Centered PD Ambulatory Monitoring System | NCT04142528

Studies
Patient-Centered PD Ambulatory Monitoring System

NCT04142528

Sponsor

Great Lakes NeuroTechnologies Inc.

Status

Unknown status

Last Update Posted

Oct 29, 2019Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Parkinson Disease

Interventions

ParkinPal

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R43NR018128-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2019Actual

Primary Completion Date

Jun 30, 2020Estimated

Completion Date

Jun 30, 2020Estimated

First Submitted Date

Oct 25, 2019

First Submission Date that Met QC Criteria

Oct 25, 2019

First Posted Date

Oct 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2019

Last Update Posted Date

Oct 29, 2019Actual

Name	Class
National Institute of Nursing Research (NINR)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parkinson's Disease		Smartwatch-based sensor assessment of PD symptoms during standard care	Device: ParkinPal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ParkinPal	Device	Wear and periodic recording of motion data during daily wear	Parkinson's Disease

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dustin Heldman, PhD	Great Lakes NeuroTechnologies	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
David E. Riley, MD		Warrensville Heights	Ohio	44128	United States

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided