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Enrolling by Invitation

NCT Number: NCT06586320

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth Hitchcock medical center

Manchester, New Hampshire, 03104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

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

    Time frame: Day 1

    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.

Secondary outcomes

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

    Time frame: Day 1

    ANLIVA® Hand Movement score of rest tremor test and postural test will be measured. Measurements are done on subjects upper limb movements. SD score of rest test and postural tremor 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.

  2. Classification between Dyskinesia or kinetic tremor

    Time frame: Day 1

    ANLIVA® Hand Movement score of kinetic tremor test and dyskinesia test will be measured. Measurements are done on subjects upper limb movements. This will be compared to assessments of SD score Dyskinesia classification.

    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.

Other outcomes

  1. Collect data for developing test for bradykinesia (exploratory)

    Time frame: Day 1

    Bradykinesia part of ANLIVA® Hand Movement will be measured. Measurements are done on subjects upper limb movements.

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

    Time frame: Day 1

    Ocular movements will be measured using ANLIVA® Eye Movement. Measurements are done on subjects eye movements

Sponsors and collaborators

Lead sponsor

Stardots AB

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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