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OpenTrials
Completed

NCT Number: NCT03638479

Utilizing Smart Devices to Identify New Phenotypical Characteristics in Movement Disorders

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Medical Informatics, University of Münster

Münster, 48149, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Capture

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universität Münster

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2018
Registry last updated
Jun 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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