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Utilizing Smart Devices to Identify New Phenotypical Characteristics in Movement Disorders

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ClinicalTrials.gov Identifier: NCT03638479
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Julian Varghese, Westfälische Wilhelms-Universität Münster

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
Parkinson Disease Essential Tremor Movement Disorders Parkinson's Syndrome Atypical Parkinsonism 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.

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Study Type : Observational
Estimated Enrollment : 500 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 : January 8, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort 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.




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. [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants who attend the ambulatory clinicic for movement disorders at the University Hospital Münster will be asked for inclusion.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638479


Contacts
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Contact: Julian Varghese, MD +492518354714 julian.varghese@ukmuenster.de

Locations
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Germany
Institute of Medical Informatics, University of Münster Recruiting
Münster, Germany, 48149
Contact: Julian Varghese, MD       julian.varghese@ukmuenster.de   
Principal Investigator: Julian Varghese, MD         
Sponsors and Collaborators
Westfälische Wilhelms-Universität Münster
Investigators
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Principal Investigator: Julian Varghese, MD WWU Münster, Institut für Medizinische Informatik
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julian Varghese, Principal Investigator, Westfälische Wilhelms-Universität Münster
ClinicalTrials.gov Identifier: NCT03638479    
Other Study ID Numbers: VA111809
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Essential Tremor
Movement Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Synucleinopathies
Neurodegenerative Diseases