Utilizing Smart Devices to Identify New Phenotypical Characteristics in Movement Disorders

Parkinson Disease Clinical Trial

Official title:

Utilizing Smart Devices to Identify New Phenotypical Characteristics in Movement Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638479
• Other study ID #: VA111809
• Status: Completed
• Start date: January 8, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2022
• Source: Westfälische Wilhelms-Universität Münster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This observational and experimental study seeks to establish a Smart Device System (SDS) to monitor high-resolution handtremor-based data using Smartphones, SmartWatches and Tablets. By doing this, movement data will be analyzed in depth with advanced statistical and Deep-Learning algorithms to identify new clinical phenotypical characteristics Parkinson's Disease and Essential Tremor.

Description:

Current smart devices as smartphones and smartwatches have reached a level of technical sophistication that enables high-resolution monitoring of movements not only for everyday sports activities but also for movement disorders. Tremor-related diseases as Parkinson's Disease (PD) and Essential Tremor (ET) are two of the most common movement disorders. Disease classification is primarily based on clinical criteria and remains challenging. The primary goal of this study is to identify new phenotypical characteristics based on the captured movement data by the tremor-capturing smartwatches and tablets and smartphone-based questionnaires.

The system will be applied and analyzed within an experimental and observational setting and only captures from patients, which have received informed consent. Within the study period, the SDS is not intended as clinical diagnostic support for physicians and will be not be used as medical device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 513
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with Parkinson's Disease (ICD-10-GM G20.-) or Essential Tremor (G25.0)

• Comparison group: Other movement disorders including atypical Parkinsonian disorders and healthy participants

Exclusion Criteria:

• Unable to obtain informed consent

• Skin-related conditions at one of the wrists or any other medical conditions that could harm the participant's health by wearing the smartwatch at both wrists.

Related Conditions & MeSH terms

• Atypical Parkinsonism
• Essential Tremor
• Movement Disorders
• Parkinson Disease
• Parkinson's Syndrome
• Parkinsonian Disorders

Intervention

Other:
• Data Capture
This is no intervention. Participants of all groups will receive data Capture with smartphones, smartwatches and tablets.

Locations

Country	Name	City	State
Germany	Institute of Medical Informatics, University of Münster	Münster

Sponsors (1)

Lead Sponsor	Collaborator
Westfälische Wilhelms-Universität Münster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceleration data in all three axes (x,y,z) measured at both wrists via Smartwatches during 10 minutes of neurological examination. Aggregated data: Mean Frequency and Amplitude of Tremor.	The raw time series data (acceleration data) and the aggregated data will be analyzed to train a neural network to classify the participant's movement disorder.	2018-2020