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

Part of paid clinical trials in Manchester, New Hampshire.

Sponsor
Stardots AB
Study ID
NCT06586320
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 150% of their routine home dopaminergic medications dose right in the clinic — DRUG
    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 — DEVICE
    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 Details

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.

Key Dates

Start date
Feb 6, 2025
Status verified
Feb 2025
Primary completion
Feb 1, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Other: ON, One visit
    Subject visit one time at clinic for tests and assessments. Subject type are Essential Tremor (ET), Healthy Control (HC) or Idiopathic Parkinson's Disease (IPD). The first arm will include the majority of subjects that will be enrolled in a onetime only study procedure performance. Subjects of this arm will carry the diagnosis of IPD, ET, or HC. After the completion of their first research visit and completing study procedures, there will be no future visits or procedures.
  • Other: OFF/ON
    Subject visit one time at clinic for tests and assessments without medication, carry out tests and assessments, then take medication according to the protocol, then carry our tests and assessments. Subject type are Idiopathic Parkinson's Disease.
  • Other: ON, Longitudinal
    IPD subjects will be asked to repeat the study visit and procedures every 6 months for longitudinal monitoring.

Primary Outcome Measure

Quantification of current IPD motor symptoms using kinetic tremor and Dyskinesia test [ Time Frame: Day 1 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth Hitchcock medical centerManchesterNew Hampshire03104-

Find similar trials in Manchester, NH

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Dartmouth Hitchcock medical center· Manchester, NH

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