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

Stardots AB

Status: Invitation-only

Conditions: Parkinson Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06586320

STUDY02002335 (Other Identifier)

STUS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 3 patient groups

ON, One visit

Other group

Description:

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.

Treatment:

Device: Evaluation of mathematical models

OFF/ON

Other group

Description:

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.

Treatment:

Drug: 150% of their routine home dopaminergic medications dose right in the clinic

Device: Evaluation of mathematical models

ON, Longitudinal

Other group

Description:

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

Treatment:

Device: Evaluation of mathematical models