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NCT Number: NCT04185740

Medication Responsiveness in Parkinson's Disease

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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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Health Behavior Medication Adherence Medication Compliance Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Patient Acceptance of Health Care Patient Compliance Smartphone Synucleinopathies Tapping Task Treatment Adherence and Compliance

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Rehabilitation Sciences

Leuven, 3001, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Tap frequency

    Time frame: 7 days

    Taps per second

  2. Mean hand movement time between taps

    Time frame: 7 days

    Inter-tap time in milliseconds

  3. Actual distance between taps

    Time frame: 7 days

    Inter-tap distance in centimeters

  4. Visual analogue scale (VAS)

    Time frame: 7 days

    To indicate the subjective medication responsiveness (current golden standard to measure medication fluctuations)

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2019
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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