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

NCT05680961 | Unknown FDA Device

• 1 other identifier: NTD-101
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Parkinson's patients

Cohort of patients with clinical diagnosis of Parkinson's diseases with varied symptoms and severity.

Device: Monitoring Device

Interventions

Monitoring Device DEVICE

Monitoring Device

Parkinson's patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Parkinson's & Movement Disorders Center of Maryland

Elkridge, Maryland, 21075, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: January 11, 2023
• Study Start: January 19, 2019
• Primary Completion: June 1, 2020
• Study Completion: August 1, 2023
• Last Updated: January 11, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)