Medication Responsiveness in Parkinson's Disease

NCT04185740 | Completed Phase 2

• 1 other identifier: S62564
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Medication Compliance; Tapping Task; Smartphone

Outcome Measures

Primary Outcomes (4)

• Tap frequency

  Taps per second

  7 days

• Mean hand movement time between taps

  Inter-tap time in milliseconds

  7 days

• Actual distance between taps

  Inter-tap distance in centimeters

  7 days

• Visual analogue scale (VAS)

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

  7 days

Study Arms (1)

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

Device: CloudUPDRS - Tapping Task

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.

Home-based validation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Department of Rehabilitation Sciences

Leuven, 3001, Belgium

Location

Related Publications (2)

• 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.

  BACKGROUND

• Broeder S, Roussos G, De Vleeschhauwer J, D'Cruz N, de Xivry JO, Nieuwboer A. A smartphone-based tapping task as a marker of medication response in Parkinson's disease: a proof of concept study. J Neural Transm (Vienna). 2023 Jul;130(7):937-947. doi: 10.1007/s00702-023-02659-w. Epub 2023 Jun 2.

  PMID: 37268772 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Medication Adherence

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Alice Nieuwboer

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 4, 2019
• Study Start: July 25, 2019
• Primary Completion: October 20, 2020
• Study Completion: October 20, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

BE (1)