Medication Responsiveness in Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-25

Study Completion Date

2020-10-20

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.

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Detailed Description

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Conditions

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Parkinson Disease Medication Compliance Tapping Task Smartphone

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Home-based validation

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

Group Type EXPERIMENTAL

CloudUPDRS - Tapping Task

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No