---
title: "Medication Responsiveness in Parkinson's Disease"
nct_id: NCT04185740
overall_status: COMPLETED
phase: PHASE2
sponsor: KU Leuven
study_type: INTERVENTIONAL
primary_condition: Parkinson Disease
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04185740.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04185740"
ct_last_update_post_date: 2021-01-27
last_seen_at: "2026-05-12T06:02:38.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Medication Responsiveness in Parkinson's Disease

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

**NCT ID:** [NCT04185740](https://clinicaltrials.gov/study/NCT04185740)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 33
- **Lead Sponsor:** KU Leuven
- **Conditions:** Parkinson Disease, Medication Compliance, Tapping Task, Smartphone
- **Start Date:** 2019-07-25
- **Completion Date:** 2020-10-20
- **CT.gov Last Update:** 2021-01-27

## 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.

## Eligibility

- **Sex:** 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
```

## Arms

- **Home-based validation** (EXPERIMENTAL) — 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

## Interventions

- **CloudUPDRS - Tapping Task** (DEVICE) — 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.

## Primary Outcomes

- **Tap frequency** _(time frame: 7 days)_ — Taps per second
- **Mean hand movement time between taps** _(time frame: 7 days)_ — Inter-tap time in milliseconds
- **Actual distance between taps** _(time frame: 7 days)_ — Inter-tap distance in centimeters
- **Visual analogue scale (VAS)** _(time frame: 7 days)_ — To indicate the subjective medication responsiveness (current golden standard to measure medication fluctuations)

## Locations (1)

- Department of Rehabilitation Sciences, Leuven, Belgium

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of rehabilitation sciences|leuven||belgium` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04185740.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04185740*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*