Clinical trial NCT06586320: Quantification of Parkinson's Disease Patients As a Biomarker for Classification, Prediction and Response to Treatment
Official title: Using Mathematical Quantification of Limb and Eye Movements of Parkinson's Disease Patients As a Biomarker for Classification and Prediction of Disease State and Response to Treatment
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Parkinson Disease
Keywords: Quantification
Biomarker
Classification
Lead sponsor: Stardots AB
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: To evaluate performance of mathematical models developed to quantify and classify symptoms and disease state using sensor data from smart phone and eye tracking cameras in subjects with Parkinson's disease.

A clinical investigator will be capturing data from the clinical encounter completed by default the same day in addition to other clinical questionnaires subjects will be filling themselves. A percentage of subjects will be asked prior to their arrival to be part of a subset study called OFF/ON study, where they will be asked not to take their IPD oral home medications prior to arrival. Both study procedure elements will be performed at the beginning of the evaluation and 60 minutes after taking their medication. There is also a longitudinal study part, where a percentage of the subjects will be asked to visit the clinic with 6 months interval, up to 4 times, including the first visit. There will be a percentage of approached subjects that belong to the category of Essential Tremor (ET) and Healthy control (HC) used for comparison purposes. ET and HC subjects will undergo the same recruitment and testing process.

Eligibility criteria: 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 outcomes:
measure: Quantification of current IPD motor symptoms using kinetic tremor and Dyskinesia test
timeFrame: Day 1
Secondary outcomes:
measure: Quantification of current IPD motor symptoms using rest tremor and postural tremor test
timeFrame: Day 1
measure: Classification between Dyskinesia or kinetic tremor
timeFrame: Day 1
Other outcomes:
measure: Collect data for developing test for bradykinesia (exploratory)
timeFrame: Day 1
measure: Derive optimized variables for objective quantification and/or classification of ocular movements (exploratory)
timeFrame: Day 1
Locations:
city: Manchester
country: United States
facility: Dartmouth Hitchcock medical center
state: New Hampshire
Study officials:
affiliation: Dartmouth Hitchcock medical center, Manchester
name: Anas Hannoun, MD
role: PRINCIPAL_INVESTIGATOR
References: