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Medication Responsiveness in Parkinson's Disease

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04185740
Enrollment
33
Registered
2019-12-04
Start date
2019-07-25
Completion date
2020-10-20
Last updated
2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Compliance, Parkinson Disease, Smartphone, Tapping Task

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.

Interventions

DEVICECloudUPDRS - 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.

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tap frequency7 daysTaps per second
Mean hand movement time between taps7 daysInter-tap time in milliseconds
Actual distance between taps7 daysInter-tap distance in centimeters
Visual analogue scale (VAS)7 daysTo indicate the subjective medication responsiveness (current golden standard to measure medication fluctuations)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026