Medication Responsiveness in Parkinson's Disease

Catholic University (KU) of Leuven

Status and phase: Completed; Phase 2

Conditions: Tapping Task; Parkinson Disease; Smartphone; Medication Compliance

Treatments: Device: CloudUPDRS - Tapping Task

Study type: Interventional

Funder types: Other

Identifiers

NCT04185740

S62564

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Home-based validation

Experimental group

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

Treatment:

Device: CloudUPDRS - Tapping Task