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

NCT06586320 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-20

No results posted yet for this 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.

Conditions

  • Parkinson Disease

Interventions

DRUG

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.

DEVICE

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

Sponsors & Collaborators

  • Stardots AB

    lead INDUSTRY

Principal Investigators

  • Anas Hannoun, MD · Dartmouth Hitchcock medical center, Manchester

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-06
Primary Completion
2027-02-01
Completion
2027-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06586320 on ClinicalTrials.gov