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Clinical Trials in the USA / NCT06586320
Enrolling by invitation Not applicable

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

NCT06586320 · tracked via the Priya Life Science USA tracker
Sponsor
Stardots AB
Phase
Not applicable
Started
2025-02-06
Last updated
2026-10-15

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

150% of their routine home dopaminergic medications dose right in the clinicEvaluation of mathematical models

150% of their routine home dopaminergic medications dose right in the clinic: IPD subjects will be informed head of time not to take their dopaminergic medications and other Parkinson's non-dopaminergic medications such as anticholinergics, NMDA inhibitors, and adenosine blockers for at least 12 hours prior to their initial procedure. Immediately, after conducting both hand movement and eye movement tests, the patient will take 150% of their routine home dopaminergic medications dose right in the clinic. They will also take their non-dopaminergic medications doses similar to home dose with no change. This will be under the supervision of their treating movement disorders specialist and study PI.

Evaluation of mathematical models: Evaluation of performance of mathematical models developed to quantify and classify symptoms and disease state using sensor data from smart phone and eye tracking cameras

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

  • Quantification of current IPD motor symptoms using kinetic tremor and Dyskinesia test — Day 1
    ANLIVA® Hand Movement score of kinetic tremor test and dyskinesia test will be measured. Measurements are done on subjects upper limb movements. SD score of kinetic tremor test and dyskinesia test will be assessed by assessors. SD is acronym for Stardots-Dartmouth score. The SD score will be used to benchmark the ANLIVA® device assessments as a nonreference standard. Minimum value is 0; maximum value is 4. A higher value on the SD score means more movement disorder.

Trial sites (1)

FacilityCityRegionStatus
Dartmouth Hitchcock medical center Manchester New Hampshire

Other trials for the same condition

Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: Recruiting
A Study of CREXONT (Carbidopa and Levodopa) Extended-Release Capsules in Participants With Parkinson's Disease Recruiting
ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease Active, not recruiting
A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease Recruiting
Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06586320 on ClinicalTrials.gov ↗ ← All trials in the USA