Status:
ENROLLING_BY_INVITATION
Quantification of Parkinson's Disease Patients As a Biomarker for Classification, Prediction and Response to Treatment
Lead Sponsor:
Stardots AB
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 i...
Detailed 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 di...
Eligibility Criteria
Inclusion
- For inclusion in the investigation, the subjects must fulfil all the below criteria prior to enrolment:
- Subjects already diagnosed with Idiopathic Parkinson's Disease (IPD)
- or subjects already diagnosed with Essential tremor (ET)
- or subjects who are healthy controls (HC) and are not diagnosed with IPD or ET
- Able to understand and sign the informed consent form.
Exclusion
- Subjects that meet any of the below criteria will be excluded:
- Not able to sign the informed consent form
- Below 18 years of age
- Diagnosed with movement disorder other than IPD or ET that might interfere with hand movements or eye movements (tics, myoclonus, chorea, dystonia, etc)
- Has parkinsonism not due to IPD (drug induced, functional, vascular, etc)
- Visual or physical limitations that prevent the subject from performing the baseline eye study requirements
- Being involved in the planning and conduct of the clinical investigation (applies to all sponsor management staff, investigational staff and third-party vendors as applicable)
Key Trial Info
Start Date :
February 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06586320
Start Date
February 6 2025
End Date
February 1 2027
Last Update
February 20 2025
Active Locations (1)
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1
Dartmouth Hitchcock medical center
Manchester, New Hampshire, United States, 03104