By InvitationNot Applicable

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

United States40 participantsStarted 2025-02-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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)

What they're measuring

Quantification of current IPD motor symptoms using kinetic tremor and Dyskinesia test

Timeframe: Day 1

Trial details

NCT IDNCT06586320

SponsorStardots AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02-01

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