Quantification of Parkinson's Disease Patients As a Biomarker for Classification, Prediction and Response to Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 150% of their routine home dopaminergic medications dose right in the clinic, Evaluation of mathematical models.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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 - 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
Primary outcome measures
- Quantification of current IPD motor symptoms using kinetic tremor and Dyskinesia test [Time frame: Day 1]
Secondary outcome measures (2)
- Quantification of current IPD motor symptoms using rest tremor and postural tremor test [Time frame: Day 1]
- Classification between Dyskinesia or kinetic tremor [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
For inclusion in the investigation, the subjects must fulfil all the below criteria prior to enrolment:
- 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.
Exclusion criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Dartmouth Hitchcock medical center — Manchester
Identifiers
NCT: NCT06586320 · STUS-001 · STUDY02002335