NCT04185740

Medication Responsiveness in Parkinson's Disease

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Parkinson Disease
• Medication Compliance
• Tapping Task
• Smartphone

Interventions

Type	Name	Description
DEVICE	CloudUPDRS - Tapping Task	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.

Timeline

• Start date: 2019-07-25
• Primary completion: 2020-10-20
• Completion: 2020-10-20
• First posted: 2019-12-04
• Last updated: 2021-01-27

Locations

1 site across 1 country: Belgium