Trial document




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  DRKS00016594

Trial Description

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Title

Utilizing Smart Devices to Identify New Phenotypical Characteristics in Movement Disorders

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Diagnosis of Parkinson's disease and Essential Tremor is primarily based on neurological examination and suffers from high misdiagnosis rates.
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 to identify new clinical phenotypical characteristics Parkinson's Disease and Essential Tremor.

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Brief Summary in Scientific Language

At the Institute of Medical Informatics Münster, a mobile system for movement analysis of patients with M. Parkinson and Essential Tremor was developed. This project is carried out as an observational study in cooperation with the Department of Neurology of the University Hospital Münster. The system consists of so-called smartwatches, which are integrated as part of a short neurological examination on both wrists of the patient and thus measure high-resolution movement data. These movement data are supplemented by electronic questionnaires, which the examiner fills in on the smartphone.

It also evaluates important family history information (e.g. is there a relative with Parkinson's disease?), medication, and questions about non-motor symptoms such as depression, fatigue and quality of life.

The study is conducted for two years and aims to train, using more than 500 patients, an AI-system (Artificial Intelligence System) to test if new phenotypical characteristics can be identified and how accurate disease classification is. After the study, these findings can be used to significantly improve diagnostic accuracy.

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Organizational Data

  •   DRKS00016594
  •   2019/01/25
  •   2018/08/20
  •   yes
  •   Approved
  •   2018-328-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   U1111-1226-8887 
  •   NCT03638479  (Clinicaltrials.gov)
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Health Condition or Problem studied

  •   G20 -  Parkinson disease
  •   G25.0 -  Essential tremor
  •   Healthy volunteers
  •   Other movement disorders including atypical Parkinsonian disorders
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Interventions/Observational Groups

  •   Patients with Parkinson's disease, Essential Tremor, and other Movement Disoders, and healthy subjects will be examined with Smart Device System. For each study participant, this system will electronically capture movement characteristics via two smartwatches in a 10 minutes neurological examination at the outpatient clinic for movement disorders (University Hospital Münster). Additionally, electronic questionnaires on medication, family history, non-motor symptoms using the PD-NMS questionnaire and spiral drawing on tablet will be captured. All of the captures data will be analyzed to identify new phenotypical patterns of M. Parkinson and Essential Tremor.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The goal of this experimental and observational study is the identification of new phenotypical characteristics in Parkinson's disease and Essential Tremor. The identification will result from training an Artificial Intelligence model.

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/01/10
  •   500
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Diagnosed with PD (ICD-10-GM G20.-) or
ET (G25.0) or other other movement disorder
2. Age ≥ 18 years

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Exclusion Criteria

1. Unable to obtain informed consent
2. 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.

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Addresses

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    • Innovative Medizinische Forschung Medizinische Fakultät MünsterWestfälische Wilhelms-Universität Münster
    • 48149  Münster
    • Germany
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    •   +49 (0)251-83-55006
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    • Institute of Medical Informatics University of Münster
    • Mr.  Julian  Varghese 
    • Albert-Schweitzer-Campus 1, Gebäude A11
    • 48149  Münster
    • Germany
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    • Institute of Medical Informatics University of Münster
    • Mr.  Julian  Vargehse 
    • Albert-Schweitzer-Campus 1, Gebäude A11
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Innovative Medizinische Forschung Medizinische Fakultät MünsterWWU Münster
    • 48149  Münster
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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