Medication Responsiveness in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04185740
• Other study ID #: S62564
• Status: Completed
• Phase: Phase 2
• Start date: July 25, 2019
• Est. completion date: October 20, 2020

Study information

• Verified date: January 2021
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 20, 2020
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Medication Compliance
• Parkinson Disease
• Smartphone
• Tapping Task

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Belgium	Department of Rehabilitation Sciences	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Stamate, C., et al., The cloudUPDRS app: A medical device for the clinical assessment of Parkinson's Disease. Pervasive and Mobile Computing, 2018. 43: p. 146-166.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tap frequency	Taps per second	7 days
Primary	Mean hand movement time between taps	Inter-tap time in milliseconds	7 days
Primary	Actual distance between taps	Inter-tap distance in centimeters	7 days
Primary	Visual analogue scale (VAS)	To indicate the subjective medication responsiveness (current golden standard to measure medication fluctuations)	7 days