Medication Responsiveness in Parkinson's Disease
Primary Purpose
Parkinson Disease, Medication Compliance, Tapping Task
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
CloudUPDRS - Tapping Task
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- Department of Rehabilitation Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Home-based validation
Arm Description
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
Outcomes
Primary Outcome Measures
Tap frequency
Taps per second
Mean hand movement time between taps
Inter-tap time in milliseconds
Actual distance between taps
Inter-tap distance in centimeters
Visual analogue scale (VAS)
To indicate the subjective medication responsiveness (current golden standard to measure medication fluctuations)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04185740
Brief Title
Medication Responsiveness in Parkinson's Disease
Official Title
The Stability in Medication Responsiveness During Research Experiments in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 25, 2019 (Actual)
Primary Completion Date
October 20, 2020 (Actual)
Study Completion Date
October 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Medication Compliance, Tapping Task, Smartphone
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home-based validation
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
CloudUPDRS - Tapping Task
Intervention Description
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 Outcome Measure Information:
Title
Tap frequency
Description
Taps per second
Time Frame
7 days
Title
Mean hand movement time between taps
Description
Inter-tap time in milliseconds
Time Frame
7 days
Title
Actual distance between taps
Description
Inter-tap distance in centimeters
Time Frame
7 days
Title
Visual analogue scale (VAS)
Description
To indicate the subjective medication responsiveness (current golden standard to measure medication fluctuations)
Time Frame
7 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Nieuwboer
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation Sciences
City
Leuven
ZIP/Postal Code
3001
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
Citation
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.
Results Reference
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Medication Responsiveness in Parkinson's Disease
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