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Clinical Trials/NCT03638479
NCT03638479
Completed
Not Applicable

Utilizing Smart Devices to Identify New Phenotypical Characteristics in Movement Disorders

Universität Münster1 site in 1 country513 target enrollmentJanuary 8, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Universität Münster
Enrollment
513
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 8, 2019
End Date
December 31, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julian Varghese

Principal Investigator

Universität Münster

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Time Frame: 2018-2020

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.

Study Sites (1)

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