Utilizing Smart Devices to Identify New Phenotypical Characteristics in Movement Disorders

Sponsor
Westfälische Wilhelms-Universität Münster (Other)
Overall Status
Completed
CT.gov ID
NCT03638479
Collaborator
(none)
513
1
35.7
14.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Data Capture

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.

Study Design

Study Type:
Observational
Actual Enrollment :
513 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Utilizing Smart Devices to Identify New Phenotypical Characteristics in Movement Disorders
Actual Study Start Date :
Jan 8, 2019
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Parkinson's Disease

Participant's diagnosed with Parkinson's Disease

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

Essential Tremor

Participant's diagnosed with Essential Tremor or other Movement Disorders

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

No Parkinson's Disease and No Essential Tremor

Participant's with no diagnosis of PD, ET or other Movement Disorders

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

Outcome Measures

Primary Outcome Measures

  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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Medical Informatics, University of Münster Münster Germany 48149

Sponsors and Collaborators

  • Westfälische Wilhelms-Universität Münster

Investigators

  • Principal Investigator: Julian Varghese, MD, WWU Münster, Institut für Medizinische Informatik

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Julian Varghese, Principal Investigator, Westfälische Wilhelms-Universität Münster
ClinicalTrials.gov Identifier:
NCT03638479
Other Study ID Numbers:
  • VA111809
First Posted:
Aug 20, 2018
Last Update Posted:
Jun 13, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 13, 2022