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

NCT06586320 | Enrolling By Invitation FDA Device

• 2 other identifiers: STUS-001STUDY02002335
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Quantification; Biomarker; Classification

Outcome Measures

Primary Outcomes (1)

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

  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.

  Day 1

Secondary Outcomes (2)

• Quantification of current IPD motor symptoms using rest tremor and postural tremor test

  Day 1

• Classification between Dyskinesia or kinetic tremor

  Day 1

Other Outcomes (2)

• Collect data for developing test for bradykinesia (exploratory)

  Day 1

• Derive optimized variables for objective quantification and/or classification of ocular movements (exploratory)

  Day 1

Study Arms (3)

ON, One visit

OTHER

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.

Device: Evaluation of mathematical models

OFF/ON

OTHER

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.

Drug: 150% of their routine home dopaminergic medications dose right in the clinic; Device: Evaluation of mathematical models

ON, Longitudinal

OTHER

IPD subjects will be asked to repeat the study visit and procedures every 6 months for longitudinal monitoring.

Device: Evaluation of mathematical models

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.

OFF/ON

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

OFF/ON; ON, Longitudinal; ON, One visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects that meet any of the below criteria will be excluded:
• 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)

Sponsors & Collaborators

• Stardots AB: lead

Study Sites (1)

Dartmouth Hitchcock medical center

Manchester, New Hampshire, 03104, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Anas Hannoun, MD

  Dartmouth Hitchcock medical center, Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 19, 2024
• Study Start: February 6, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)