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Movement DisordersNCT04074772

Leveraging Machine Learning to Effortlessly Track Patient Movement in the Clinic.

An observational study of Movement Disorders, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is the development of a system that will allow for the precise measurement of movement kinematics in a clinical exam setting using natural video from three cameras and machine learning to track points of interest. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Movement Disorders
How many people
25 participants
Where
1 siteUnited States
Study dates
7 Dec 2020to 1 Oct 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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: * Healthy controls: health volunteers recruited within the Anschutz Medical Campus * Age-Matched controls: spouses and relatives of patients visiting the movement disorders clinic at the University of Colorado Hospital within 10 years of patient's age. * Movement Disorder Patients: patients visiting the movement disorders clinic at the University of Colorado Hospital

Who may be able to join

  • Healthy controls: within age range
  • Age-Matched controls: within age range
  • Movement Disorder Patients: have diagnosed or putative movement disorder

Who cannot join

  • Healthy controls: have diagnosed or putative movement disorder; outside of age range
  • Age-Matched controls: have diagnosed or putative movement disorder; outside of age range
  • Movement Disorder Patients: outside of age range

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Colorado Hospital

    Aurora, Colorado, 80045

Other trials in United States

About this study

The objective of this study is the development of a system that will allow for the precise measurement of movement kinematics in a clinical exam setting using natural video from three cameras and machine learning to track points of interest. The investigators aim to implement such system in an unobtrusive and simply-incorporated way into the physical exam to provide exact, objective measures to detect patient movement abnormalities in ways not feasible with current tracking technologies.

Read the detailed description

Aim 1: Develop 3D tracking capable of capturing behavior of healthy controls during physical exams. In aim 1, the investigators will recruit healthy volunteers to perform a simplified physical exam in a replica exam room while being recorded with three synchronized FLIR cameras. The simplified exam will consist of four tasks: assessment of tremor, finger chase, finger-to-nose movements, and finger tapping. Study staff will then use DeepLabCut (DLC) software -technology that trains artificial neural networks to identify user defined features in an image - to recognize body parts of interest in physical exam videos. Once the network is fully trained the investigators will test its ability to generalize on different patients and different contexts. Additional analysis of volunteers' movement during the physical exam will be performed to assess for characteristics such as tremor, speed, and tortuosity of movement.

Aim 2: Apply 3D tracking to the clinic to track physical exam behaviors in motor disorder patients. In aim 2, the investigators will apply the trained network to the clinic to examine the physical exam characteristics of movement disorder patients. Aim 2a will test the DLC network's ability to capture movement disorder abnormalities during the physical exam in patients and healthy age-matched controls. DLC scores of each test variable will be compared to the physician's score of movement according to a standardized scale. The investigators expect to find that the DLC tracking method is able to objectively score movement disorders in ways that mirror and surpass the ability of the physician. In Aim 2b, the investigators will explore the population of recruited patients to see whether it is possible to pull out characteristic movements that correspond to certain disease states. In this exploratory aim, the investigators expect to be able to separate different disease groups (e.g.: Parkinsonian and ataxic patients) from each other based simply on the tracked movement characteristics.

Research Methods:

In Aim 1, a movement arena will be built on the University of Colorado Denver Graduate School campus using three FLIR cameras with a custom built synchronization and initiation system. The investigators will recruit up to 30 healthy 18-70-year-old controls from the University of Colorado Denver Graduate School to perform the simplified physical exam (assessment of tremor, finger chase, finger-to-nose movements, and finger tapping) while video is captured from three angles at 100 Hz. The investigators expect this testing to take no more than 5 minutes per subject. This video will be used to train the DLC artificial neural network to recognize limb features. The investigators will measure the ability of our trained DLC network to characterize twelve points of interest on each limb during a physical exam: the tips of the four fingers and the thumb, all four metacarpophalangeal joints, the center of the hand, the elbow, and the shoulder. A successful outcome will be a network that maintains the ability to recognize features of interest at high confidence between different individuals and different room contexts.

In Aim 2a, a tracking arena will be set up in a University of Colorado Movement Disorder Clinic exam room. The investigators will recruit up to 100 patients between 18-70 years old that are visiting for a movement disorder related appointment as well as spouses and relatives of the patients at the appointment for healthy age-matched controls. Patients in the clinic will be asked after their visit if they would like to participate in the study. If they consent, the physician will obtain written consent and fill out a patient form that includes the patient's age, race, sex, and diagnosis (or putative diagnosis). Video recording will be started and the physician will perform the simplified physical exam mentioned above. The physicians will judge the finger chase and finger-to-nose task as is described in the Scale for the Assessment and Rating of Ataxia (SARA, items 5 \& 6) from 0-4. The postural tremor and finger tapping will be judged according to the Unified Parkinson Disease Rating Scale (UPDRS, items 21 \& 23) from 0-4. If the patient is visiting with a person that consents to be an age-matched control (within 10 years of the patient's age) the physical exam will be repeated as above. The investigators expect this testing to take no more than 5 minutes per subject, beginning to end. The investigators will then use the DLC algorithm to score the physical exam in a way analogous to the physician scoring to assess the accuracy of the system.

In Aim 2b, the investigators will explore the patient data from Aim 2a for movement features specific to individual diseases. Data clustering methods (PCA and t-SNE) will be used to separate data into groups using high-dimensional DLC tracking data from each physical exam task. Success will be measured as the ability to separate diseases from one another based solely on the analysis of movement data.

Medical subject headings
Movement Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04074772
Study groupRoleWhat they receive
Healthy ControlsThis group will consist of healthy controls between the ages of 18 and 70-years-old. Following consent, they will complete a simplified motor physical exam while being filmed from three angles. This video data will be used to train a neural network to identify points of interest in a generalized patient population.
Movement Disorder PatientsThis group will consist of movement disorder clinic patients between the ages of 18 and 70-years-old with a diagnosed or putative movement disorder. Following consent, they will complete a simplified motor physical exam while being filmed from three angles. This video data will be analyzed with the neural network trained on the healthy controls.
Age-Matched ControlsThis group will consist of relatives of movement disorder clinic patients that are visiting with them to serve as age-matched controls (within 10 years of patient's age). Following consent, they will complete a simplified motor physical exam while being filmed from three angles. This video data will be analyzed with the neural network trained on the healthy controls.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful Tracking Achieved in Clinic

    If the neural network can generalize to different patients and contexts with accurate tracking, such that it can track all 12 points of interest with >99% accuracy in >95% of frames of novel video data, the investigators will consider this outcome a success.

    Measured: On the day of physical exam

Secondary outcomes (1)
  1. Identification of Diseases by Movement Tracking

    If the investigators can separate different movement disorders from one another based on tracking data alone this outcome will be considered a success. Specifically, in LOTO cross validation, individual patient data must be assigned the correct disease state with 95% confidence.

    Measured: On the day of physical exam

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2019
  2. Study start7 Dec 2020
  3. Primary completion1 Oct 2021
  4. Study completion1 Oct 2021

Resources

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
Other
Time perspective
Other
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04074772
Sponsor's protocol ID
19-1250
Status last verified
Jan 2022
First submitted
27 Aug 2019
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Will not share IPD

Publications

  • Mathis A, Mamidanna P, Cury KM, Abe T, Murthy VN, Mathis MW, Bethge M. DeepLabCut: markerless pose estimation of user-defined body parts with deep learning. Nat Neurosci. 2018 Sep;21(9):1281-1289. doi: 10.1038/s41593-018-0209-y. Epub 2018 Aug 20.

    PubMed 30127430

Questions about this trial

What is this clinical trial studying?

An observational study of Movement Disorders, run by University of Colorado, Denver at 1 site in United States.

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 3 inclusion and 3 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 11 Jan 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 United States. 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?

Successful Tracking Achieved in Clinic (time frame: On the day of physical exam). 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 NCT04074772, which also lists 1 linked publication.

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 11 Jan 2022.

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