Medication Responsiveness in Parkinson's Disease

Study Overview
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Brief Summary
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Up till now, dopaminergic replacement is considered as the gold standard for the symptomatic treatment of motor symptoms in Parkinson's disease (PD). However, the intake, especially higher doses when taken for a longer duration, are associated with several side effects including response fluctuations. These fluctuations in medication response are often characterized by a wearing-OFF period, also defined as the recurrence of PD symptoms before a patient should take the next dose of medication. The duration of test sessions during research experiments (e.g. in the field of rehabilitation) can interfere with the period of the optimal therapeutic effect of dopaminergic medication, influencing outcomes of a study. Therefore, the objective of this project is to get more insight in the measurability of ON-OFF fluctuations by testing the applicability of a short and simple timed tapping task (TTT) on a smartphone in rehabilitation research studies. The assessment can be useful for future clinical studies in PD where a precise estimation of medication is indispensable for accurate research outcomes.

Official Title
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The Stability in Medication Responsiveness During Research Experiments in Parkinson's Disease

Conditions
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Parkinson Disease, Medication Compliance, Tapping Task, Smartphone

Intervention / Treatment
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* Device: CloudUPDRS - Tapping Task


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of PD, based on the UK Brain Bank Diagnostic Criteria Hoehn & Yahr stage I-III Mini Mental State Examination (MMSE) scores >24 Right-handedness No other known disease or disorder that will interfere with the experiments
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based validation<br>The home-based validation of the TTT will give insight in the task performance of patients OFF-medication compared to ON-medication and on different time points in the medication cycle during 7 days | Device: CloudUPDRS - Tapping Task<br>* The TTT, consisting of two targets, will be presented on the screen of the smartphone. Participants will be instructed to alternate between the two targets using their index finger for 30 seconds. The task will always be performed with the left hand first and then with the right hand. The touch-sensitive screen of the smartphone will measure the timing of each touch event, its duration, the coordinates on the phone screen and the amount of pressure applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tap frequency | Taps per second | 7 days | 
| Mean hand movement time between taps | Inter-tap time in milliseconds | 7 days | 
| Actual distance between taps | Inter-tap distance in centimeters | 7 days | 
| Visual analogue scale (VAS) | To indicate the subjective medication responsiveness (current golden standard to measure medication fluctuations) | 7 days |