Parkinson DiseaseNCT03638479
Utilizing Smart Devices to Identify New Phenotypical Characteristics in Movement Disorders
An observational study of Parkinson Disease and Essential Tremor, run by Universität Münster at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Essential Tremor, Movement Disorders
- What is being tested?
- Data Capture
- Type of treatment
- Pill or oral medicine
- How many people
- 513 participants
- Where
- 1 siteGermany
- Study dates
- 8 Jan 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants who attend the ambulatory clinicic for movement disorders at the University Hospital Münster will be asked for inclusion.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Informatics, University of Münster
Münster, 48149
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease, Essential Tremor, Movement Disorders, Parkinson's Syndrome, Atypical Parkinsonism
- Being tested
- Data Capture
- Medical subject headings
- Parkinson Disease, Essential Tremor, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CaptureOther
This is no intervention. Participants of all groups will receive data Capture with smartphones, smartwatches and tablets.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease | Participant's diagnosed with Parkinson's Disease Receives: Other: Data Capture | |
| Essential Tremor | Participant's diagnosed with Essential Tremor or other Movement Disorders Receives: Other: Data Capture | |
| No Parkinson's Disease and No Essential Tremor | Participant's with no diagnosis of PD, ET or other Movement Disorders Receives: Other: Data Capture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2018-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start8 Jan 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 513 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Münster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Varghese, Universität Münster
- Investigators
- Julian Varghese, MD, Principal investigator, WWU Münster, Institut für Medizinische Informatik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638479
- Sponsor's protocol ID
- VA111809
- Status last verified
- Jun 2022
- First submitted
- 13 Aug 2018
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37365210Varghese 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.
PubMed 30761078
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Smart Devices to Identify New Phenotypical Characteristics in Movement Disorders
- ClinicalTrials.gov ID
- NCT03638479
- Acronym / sponsor ID
- VA111809
- Conditions
- Parkinson Disease, Essential Tremor, Movement Disorders, Parkinson's Syndrome, Atypical Parkinsonism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- Universität MünsterUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease | – | Other: Data CaptureParticipant's diagnosed with Parkinson's Disease |
| Essential Tremor | – | Other: Data CaptureParticipant's diagnosed with Essential Tremor or other Movement Disorders |
| No Parkinson's Disease and No Essential Tremor | – | Other: Data CaptureParticipant's with no diagnosis of PD, ET or other Movement Disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who attend the ambulatory clinicic for movement disorders at the University Hospital Münster will be asked for inclusion.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data CaptureThis is no intervention. Participants of all groups will receive data Capture with smartphones, smartwatches and tablets. | Other | Essential Tremor, No Parkinson's Disease and No Essential Tremor, Parkinson's Disease |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Derived from this study: PubMed 37365210Purk 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.
- Derived from this study: PubMed 30761078Varghese 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian Varghese, MD principal investigator
WWU Münster, Institut für Medizinische Informatik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Essential Tremor, run by Universität Münster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2018-2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03638479, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.