Monitoring Movement Disorder Symptoms With a Mobile Medic... | NCT05680961

Studies
Monitoring Movement Disorder Symptoms With a Mobile Medical App on Off-the-shelf Consumer Mobile Devices

NCT05680961

Sponsor

Parkinson's & Movement Disorders Center of Maryland

Status

Unknown status

Last Update Posted

Jan 11, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Parkinson Disease

Interventions

Monitoring Device

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

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 19, 2019Actual

Primary Completion Date

Jun 1, 2020Actual

Completion Date

Aug 1, 2023Estimated

First Submitted Date

Jun 21, 2022

First Submission Date that Met QC Criteria

Dec 27, 2022

First Posted Date

Jan 11, 2023Actual

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

Dec 27, 2022

Last Update Posted Date

Jan 11, 2023Actual

Name	Class
New Touch Digital Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate whether New Touch Digital (NTD) NeuroRPM software installed on wearable devices can objectively measure and track symptoms in patients with Parkinson's disease.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parkinson's patients		Cohort of patients with clinical diagnosis of Parkinson's diseases with varied symptoms and severity.	Device: Monitoring Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Monitoring Device	Device	Monitoring Device	Parkinson's patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
NeuroRPM UPDRS predicted score vs. clinical raters' UPDRS	We will compare symptom severity as predicted by NeuroRPM to UPDRS scores from clinical raters. Statistical significance will be evaluated by intraclass correlation and kappa-statistic.	Comparison will be performed upon completion of the study, approximately in 1 year.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is 18 years of age or older
Subject is able to provide informed written consent
Subject has been clinically diagnosed with Parkinson's Disease
Subject is mentally and physically capable of performing tasks on the mobile device and related physical activities herein described

Exclusion Criteria:

Inability to give informed consent
Presence of additional neurological disease aside from the diseases being studied
Inability to understand and follow the directions for the study

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 study is open to persons 18 years of age and older with a clinical diagnosis of Parkinson's diseases without other neurological diseases.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Parkinson's & Movement Disorders Center of Maryland		Elkridge	Maryland	21075	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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

Intervention Browse Module

MeSH Terms

ID	Term
D008991	Monitoring, Physiologic

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided