Utilizing Smart Devices to Identify New Phenotypical Characteristics in Movement Disorders

NCT03638479 | Completed

• 1 other identifier: VA111809
• Study Type: observational
• Target: 513
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

  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

Study Arms (3)

Parkinson's Disease

Participant's diagnosed with Parkinson's Disease

Other: Data Capture

Essential Tremor

Participant's diagnosed with Essential Tremor or other Movement Disorders

Other: Data Capture

No Parkinson's Disease and No Essential Tremor

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

Other: Data Capture

Interventions

Data Capture OTHER

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

Essential Tremor; No Parkinson's Disease and No Essential Tremor; Parkinson's Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universität Münster: lead

Study Sites (1)

Institute of Medical Informatics, University of Münster

Münster, 48149, Germany

Location

Related Publications (2)

• Purk M, Fujarski M, Becker M, Warnecke T, Varghese J. Utilizing a tablet-based artificial intelligence system to assess movement disorders in a prospective study. Sci Rep. 2023 Jun 26;13(1):10362. doi: 10.1038/s41598-023-37388-3.

  PMID: 37365210 DERIVED

• Varghese J, Niewohner S, Soto-Rey I, Schipmann-Miletic S, Warneke N, Warnecke T, Dugas M. A Smart Device System to Identify New Phenotypical Characteristics in Movement Disorders. Front Neurol. 2019 Jan 30;10:48. doi: 10.3389/fneur.2019.00048. eCollection 2019.

  PMID: 30761078 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor; Movement Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Julian Varghese, MD

  WWU Münster, Institut für Medizinische Informatik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 20, 2018
• Study Start: January 8, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)