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Dopaminergic agents

Dopaminergic Medication Adjustment for Parkinson's Disease

N/A

Recruiting

Led By Anas Hannoun, MD

Research Sponsored by Stardots AB

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects already diagnosed with Essential tremor (ET)

Subjects who are healthy controls (HC) and are not diagnosed with IPD or ET

Must not have

Not able to sign the informed consent form

Below 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to use new devices to study abnormal eye and upper limb movements in Parkinson's disease patients.

Who is the study for?

This trial is for Parkinson's Disease patients who can safely receive a higher dose of their usual Parkinson's medication in the clinic. Specific eligibility details are not provided, so it's important to contact the study team for more information.

What is being tested?

The study tests how increased doses of dopaminergic medications affect eye and hand movements in Parkinson's patients, using non-invasive devices called ANLIVA® Hand Movement and ANLIVA® Eye Movement.

What are the potential side effects?

Potential side effects may include those associated with an increased dose of dopaminergic medications such as nausea, dizziness, low blood pressure, sleepiness or other movement-related symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Essential Tremor.

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I am healthy and do not have IPD or ET.

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I have been diagnosed with Parkinson's Disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to sign the consent form.

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I am under 18 years old.

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My parkinsonism is not caused by Parkinson's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Classification between Dyskinesia or kinetic tremor

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

Other study objectives

Collect data for developing test for bradykinesia (exploratory)

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: ON, One visitExperimental Treatment1 Intervention

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.

Group II: ON, LongitudinalExperimental Treatment1 Intervention

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

Group III: OFF/ONExperimental Treatment2 Interventions

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.

0 / 6Eligibility criteria met