Medication Responsiveness in Parkinson's Disease
- Conditions
- Tapping TaskSmartphoneParkinson DiseaseMedication Compliance
- Interventions
- Device: CloudUPDRS - Tapping Task
- Registration Number
- NCT04185740
- Lead Sponsor
- KU Leuven
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Home-based validation CloudUPDRS - Tapping Task 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
- Primary Outcome Measures
Name Time Method Tap frequency 7 days Taps per second
Actual distance between taps 7 days Inter-tap distance in centimeters
Visual analogue scale (VAS) 7 days To indicate the subjective medication responsiveness (current golden standard to measure medication fluctuations)
Mean hand movement time between taps 7 days Inter-tap time in milliseconds
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Rehabilitation Sciences
🇧🇪Leuven, Belgium