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Enrolling By Invitation
NCT06586320
Quantification of Parkinson's Disease Patients as a Biomarker for Classification, Prediction and Response to Treatment
Conditions: Parkinson Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 40
Sponsor: Stardots AB
Location: Dartmouth Hitchcock medical center Manchester New Hampshire
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 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 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 hand movements 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 baseline eye study requirements
6. 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)
Source: ClinicalTrials.gov (NCT06586320). StuddyBuddy aggregates publicly available trial information.