Clinical trial NCT03638479: Utilizing Smart Devices to Identify New Phenotypical Characteristics in Movement Disorders
Official title: Utilizing Smart Devices to Identify New Phenotypical Characteristics in Movement Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Essential Tremor
Movement Disorders
Parkinson's Syndrome
Atypical Parkinsonism
Lead sponsor: Universität Münster
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 513
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 2018-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Institute of Medical Informatics, University of Münster
Study officials:
affiliation: WWU Münster, Institut für Medizinische Informatik
name: Julian Varghese, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.