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

• Sponsor: Parkinson's & Movement Disorders Center of Maryland (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05680961
• Collaborator: New Touch Digital Inc. (Industry)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 54.4
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Device: Monitoring Device

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Monitoring Movement Disorder Symptoms With a Mobile Medical App on Off-the-shelf Consumer Mobile Devices
• Actual Study Start Date: Jan 19, 2019
• Actual Primary Completion Date: Jun 1, 2020
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Parkinson's patients Cohort of patients with clinical diagnosis of Parkinson's diseases with varied symptoms and severity.	Device: Monitoring Device; Monitoring Device

Outcome Measures

Primary Outcome Measures

1. NeuroRPM UPDRS predicted score vs. clinical raters' UPDRS [Comparison will be performed upon completion of the study, approximately in 1 year.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject is 18 years of age or older

2. Subject is able to provide informed written consent

3. Subject has been clinically diagnosed with Parkinson's Disease

4. Subject is mentally and physically capable of performing tasks on the mobile device and related physical activities herein described

Exclusion Criteria:

1. Inability to give informed consent

2. Presence of additional neurological disease aside from the diseases being studied

3. Inability to understand and follow the directions for the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parkinson's & Movement Disorders Center of Maryland	Elkridge	Maryland	United States	21075

Sponsors and Collaborators

• Parkinson's & Movement Disorders Center of Maryland
• New Touch Digital Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Parkinson's & Movement Disorders Center of Maryland
• ClinicalTrials.gov Identifier: NCT05680961
• Other Study ID Numbers: NTD-101
• First Posted: Jan 11, 2023
• Last Update Posted: Jan 11, 2023
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Parkinson's & Movement Disorders Center of Maryland: Parkinson's disease
• Additional relevant MeSH terms: Parkinson Disease; Movement Disorders

Study Results

No Results Posted as of Jan 11, 2023