Parkinson DiseasePhase 2NCT04185740
Medication Responsiveness in Parkinson's Disease
A Phase 2 study testing CloudUPDRS - Tapping Task in people with Parkinson Disease and Medication Compliance, run by KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Medication Compliance, Tapping Task
- What is being tested?
- CloudUPDRS - Tapping Task
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Jul 2019to 20 Oct 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Stability in Medication Responsiveness During Research Experiments 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.
- Conditions
- Parkinson Disease, Medication Compliance, Tapping Task, Smartphone
- Being tested
- CloudUPDRS - Tapping Task
- Medical subject headings
- Parkinson Disease, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CloudUPDRS - Tapping TaskDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: CloudUPDRS - Tapping Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tap frequency
Taps per second
Measured: 7 days
Mean hand movement time between taps
Inter-tap time in milliseconds
Measured: 7 days
Actual distance between taps
Inter-tap distance in centimeters
Measured: 7 days
Visual analogue scale (VAS)
To indicate the subjective medication responsiveness (current golden standard to measure medication fluctuations)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start25 Jul 2019
- Primary completion20 Oct 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Nieuwboer, KU Leuven
- Investigators
- Alice Nieuwboer, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185740
- Sponsor's protocol ID
- S62564
- Status last verified
- Jan 2021
- First submitted
- 26 Nov 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
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.
PubMed 37268772
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Stability in Medication Responsiveness During Research Experiments in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04185740
- Acronym / sponsor ID
- S62564
- Conditions
- Parkinson Disease, Medication Compliance, Tapping Task, Smartphone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-based validation | Experimental | Device: CloudUPDRS - Tapping TaskThe 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CloudUPDRS - Tapping TaskThe 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. | Device | Home-based validation |
Primary outcome
Tap frequency
Time frame: 7 days
Taps per second
Mean hand movement time between taps
Time frame: 7 days
Inter-tap time in milliseconds
Actual distance between taps
Time frame: 7 days
Inter-tap distance in centimeters
Visual analogue scale (VAS)
Time frame: 7 days
To indicate the subjective medication responsiveness (current golden standard to measure medication fluctuations)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- BackgroundStamate, 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.
- Derived from this study: PubMed 37268772Broeder 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Nieuwboer principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CloudUPDRS - Tapping Task in people with Parkinson Disease and Medication Compliance, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tap frequency (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04185740, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.