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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05680961
• Other study ID #: NTD-101
• Status: Active, not recruiting
• Start date: January 19, 2019
• Est. completion date: August 1, 2023

Study information

• Verified date: December 2022
• Source: Parkinson's & Movement Disorders Center of Maryland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: August 1, 2023
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Movement Disorders
• Parkinson Disease

Intervention

Device:
• Monitoring Device
Monitoring Device

Locations

Country	Name	City	State
United States	Parkinson's & Movement Disorders Center of Maryland	Elkridge	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Parkinson's & Movement Disorders Center of Maryland	New Touch Digital Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.