Parkinson DiseaseNCT06586320
Quantification of Parkinson's Disease Patients as a Biomarker for Classification, Prediction and Response to Treatment
A study testing 150% of their routine home dopaminergic medications dose right in the clinic and Evaluation of mathematical models in people with Parkinson Disease, run by Stardots AB at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- 150% of their routine home dopaminergic medications dose right in the clinic and Evaluation of mathematical models
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dartmouth Hitchcock medical center
Manchester, New Hampshire, 03104
About this study
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
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- 150% of their routine home dopaminergic medications dose right in the clinic, Evaluation of mathematical models
- Keywords
- Quantification, Biomarker, Classification
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
150% of their routine home dopaminergic medications dose right in the clinicDrug
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 modelsDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Evaluation of mathematical models |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (2)
Quantification of current IPD motor symptoms using rest tremor and postural tremor test
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.
Measured: Day 1
Classification between Dyskinesia or kinetic tremor
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start6 Feb 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stardots AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anas Hannoun, MD, Principal investigator, Dartmouth Hitchcock medical center, Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586320
- Sponsor's protocol ID
- STUS-001
- Other IDs
- STUDY02002335
- Status last verified
- Apr 2026
- First submitted
- 26 Aug 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06586320
- Acronym / sponsor ID
- STUS-001
- Conditions
- Parkinson Disease
- Keywords
- Quantification, Biomarker, Classification
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stardots ABIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ON, One visit | Other | Device: Evaluation of mathematical modelsSubject 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. |
| OFF/ON | Other | Drug: 150% of their routine home dopaminergic medications dose right in the clinic, Device: Evaluation of mathematical modelsSubject 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. |
| ON, Longitudinal | Other | Device: Evaluation of mathematical modelsIPD subjects will be asked to repeat the study visit and procedures every 6 months for longitudinal monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 150% of their routine home dopaminergic medications dose right in the clinicIPD 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. | Drug | OFF/ON |
| Evaluation of mathematical modelsEvaluation of performance of mathematical models developed to quantify and classify symptoms and disease state using sensor data from smart phone and eye tracking cameras | Device | OFF/ON, ON, Longitudinal, ON, One visit |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anas Hannoun, MD principal investigator
Dartmouth Hitchcock medical center, Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 150% of their routine home dopaminergic medications dose right in the clinic and Evaluation of mathematical models in people with Parkinson Disease, run by Stardots AB at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of current IPD motor symptoms using kinetic tremor and Dyskinesia test (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.