Quantification of Parkinson's Disease Patients As a Biomarker for Classification, Prediction and Response to Treatment

Last updated: February 19, 2025
Sponsor: Stardots AB
Overall Status: Active - Enrolling

Phase

N/A

Condition

N/A

Treatment

Evaluation of mathematical models

150% of their routine home dopaminergic medications dose right in the clinic

Clinical Study ID

NCT06586320
STUS-001
STUDY02002335
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a three-armed open investigational study that aims to differentiate, quantify, and categorize abnormal eye movements and upper limbs movements in patients with Parkinson's disease. The study is using investigational non-invasive devices for that reason including ANLIVA® Hand Movement and ANLIVA® Eye Movement.

Eligibility Criteria

Inclusion

Inclusion Criteria:

For inclusion in the investigation, the subjects must fulfil all the below criteria prior to enrolment:

  1. Subjects already diagnosed with Idiopathic Parkinson's Disease (IPD)

  2. or subjects already diagnosed with Essential tremor (ET)

  3. or subjects who are healthy controls (HC) and are not diagnosed with IPD or ET

  4. Able to understand and sign the informed consent form.

Exclusion

Exclusion Criteria:

Subjects that meet any of the below criteria will be excluded:

  1. Not able to sign the informed consent form

  2. Below 18 years of age

  3. Diagnosed with movement disorder other than IPD or ET that might interfere with handmovements or eye movements (tics, myoclonus, chorea, dystonia, etc)

  4. Has parkinsonism not due to IPD (drug induced, functional, vascular, etc)

  5. Visual or physical limitations that prevent the subject from performing the baselineeye study requirements

  6. Being involved in the planning and conduct of the clinical investigation (applies toall sponsor management staff, investigational staff and third-party vendors asapplicable)

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Evaluation of mathematical models
Phase:
Study Start date:
February 06, 2025
Estimated Completion Date:
February 01, 2027

Study Description

To evaluate performance of mathematical models developed to quantify and classify symptoms and disease state using sensor data from smart phone and eye tracking cameras in subjects with Parkinson's disease.

A clinical investigator will be capturing data from the clinical encounter completed by default the same day in addition to other clinical questionnaires subjects will be filling themselves. A percentage of subjects will be asked prior to their arrival to be part of a subset study called OFF/ON study, where they will be asked not to take their IPD oral home medications prior to arrival. Both study procedure elements will be performed at the beginning of the evaluation and 60 minutes after taking their medication. There is also a longitudinal study part, where a percentage of the subjects will be asked to visit the clinic with 6 months interval, up to 4 times, including the first visit. There will be a percentage of approached subjects that belong to the category of Essential Tremor (ET) and Healthy control (HC) used for comparison purposes. ET and HC subjects will undergo the same recruitment and testing process.

Connect with a study center

  • Dartmouth Hitchcock medical center

    Manchester, New Hampshire 03104
    United States

    Site Not Available

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