Parkinson Disease(PD)RPPDNCT07647913
Rhythm Psychophysics With Parkinson's Patients
A study testing Withholding Levodopa in people with Parkinson Disease(PD), run by McMaster University at 1 site in Canada.
Trial summary
The goal of this interventional study is to understand how the rhythmic abilities of individuals in the early stages of Parkinson's Disease (PD) are impacted by their levels of dopamine. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease(PD)
- What is being tested?
- Withholding Levodopa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2026to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's Disease diagnostic
- Stage 1 or 2 Hoenh-Yahr scale
- Taking immediate-release Levodopa
- MoCA score of 26 or above
Who cannot join
- Dementia
- Other neurodegenerative disease
- History of substance abuse
- History of hearing disorders
- History of neuropsychiatric disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Itzamna Sanchez Moncada, Dr contact
Canada1 site
Psychology Building
Hamilton, Ontario, L8S 4L8
Jonathan Cannon, Dr, 9055259140, cannoj9@mcmaster.ca
Itzamna Sanchez Moncada, Dr, 3653572844, sanchei@mcmaster.ca
About this study
The goal of this interventional study is to understand how the rhythmic abilities of individuals in the early stages of Parkinson's Disease (PD) are impacted by their levels of dopamine. The main questions it aims to answer are:
- Does dopamine shelter the ability to generate and maintain a regular tapping rhythm in the presence of disrupting sensory information?
- Does dopamine allow the adaptation of tapping speed in the presence of changing sensory information?
- Is the engagement of the motor system useful to improve the detection of changes in the tempo of sensory information?
Participants will be asked to perform a battery of simple rhythmic tasks On and Off medication to evaluate the effect of dopamine on their rhythmic skills.
- Conditions
- Parkinson Disease(PD)
- Being tested
- Withholding Levodopa
- Keywords
- Parkinson Disease, PD, Rhythm, Sensorymotor synchronization, Perceptual timing, Motor timing, Interval timing
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withholding LevodopaDrug
Participants will have to withhold Levodopa medication 12 h before one of two experimental sessions.
| Study group | Role | What they receive |
|---|---|---|
| Medication state | Experimental | Participants will have to attend two sessions scheduled approximately one week apart. During one session, participants will be tested while On medication (levodopa). During the other session, participants will be asked to withhold their medication for 12 hours prior to the experimental session. The order of the sessions will be randomized across participants. Receives: Drug: Withholding Levodopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mean inter-tap intervals following Levodopa withdrawal during rhythmic tapping tasks.
Audio recordings from the tapping tasks will be processed to extract onset times corresponding to participant taps (milliseconds). These onset times will be used to compute inter-tap intervals (ITI) by subtracting the earlier onset time from the later one (milliseconds).
Measured: Between experimental sessions one and two, which will take place approximately one week apart.
Changes in constant error following Levodopa withdrawal during rhythmic tapping tasks.
Audio recordings from the tapping tasks will be processed to extract the onset times of participant taps (milliseconds). These onset times will be used to compute the constant error (milliseconds) by subtracting the base interval (milliseconds) from the mean inter-tap interval (milliseconds).
Measured: Between experimental sessions one and two, which will take place approximately one week apart.
Changes in asynchronies following Levodopa withdrawal during rhythmic tapping tasks.
Audio recordings from the tapping tasks will be processed to extract onset times corresponding to auditory cues and participant taps (both in milliseconds). These onset times will be used to compute asynchronies (milliseconds) between the auditory cues and the taps. The asynchronies will be calculated by subtracting the tap onset from the corresponding auditory cue onset.
Measured: Between experimental sessions one and two, which will take place approximately one week apart.
Secondary outcomes (2)
Impact of Levodopa withdrawal on motor symptoms severity scales.
Motor symptom severity will be assessed with Part III of the Unified Parkinson's Disease Rating Scale (UPDRS-III). Scores range from 0 to 132, with higher scores reflecting more severe motor symptoms.
Measured: Between experimental Sessions one and two, which will take place approximately one week apart.
Impact of Levodopa withdrawal on motor symptoms severity scales.
Cognitive assessment will be performed using the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG). Scores range from 0 to 43, with higher scores reflecting better cognitive function.
Measured: Between experimental sessions one and two, which will take place approximately one week apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Parkinson Disease(PD)Studies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional within-subject non-therapeutic trial
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647913
- Sponsor's protocol ID
- 19513
- Other IDs
- RGEC27/2025
- Acronym
- RPPD
- Status last verified
- May 2026
- First submitted
- 1 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gratton I, Brandimonte MA, Bruno N. Absolute Memory for Tempo in Musicians and Non-Musicians. PLoS One. 2016 Oct 19;11(10):e0163558. doi: 10.1371/journal.pone.0163558. eCollection 2016.
PubMed 27760198Zhou ZD, Yi LX, Wang DQ, Lim TM, Tan EK. Role of dopamine in the pathophysiology of Parkinson's disease. Transl Neurodegener. 2023 Sep 18;12(1):44. doi: 10.1186/s40035-023-00378-6.
PubMed 37718439Yc K, Prado L, Merchant H. The scalar property during isochronous tapping is disrupted by a D2-like agonist in the nonhuman primate. J Neurophysiol. 2019 Mar 1;121(3):940-949. doi: 10.1152/jn.00804.2018. Epub 2018 Dec 21.
PubMed 30575431Witt ST, Laird AR, Meyerand ME. Functional neuroimaging correlates of finger-tapping task variations: an ALE meta-analysis. Neuroimage. 2008 Aug 1;42(1):343-56. doi: 10.1016/j.neuroimage.2008.04.025. Epub 2008 Apr 16.
PubMed 18511305Vishne G, Jacoby N, Malinovitch T, Epstein T, Frenkel O, Ahissar M. Slow update of internal representations impedes synchronization in autism. Nat Commun. 2021 Sep 14;12(1):5439. doi: 10.1038/s41467-021-25740-y.
PubMed 34521851van der Steen MC, Keller PE. The ADaptation and Anticipation Model (ADAM) of sensorimotor synchronization. Front Hum Neurosci. 2013 Jun 10;7:253. doi: 10.3389/fnhum.2013.00253. eCollection 2013.
PubMed 23772211Schwartze M, Keller PE, Patel AD, Kotz SA. The impact of basal ganglia lesions on sensorimotor synchronization, spontaneous motor tempo, and the detection of tempo changes. Behav Brain Res. 2011 Jan 20;216(2):685-91. doi: 10.1016/j.bbr.2010.09.015. Epub 2010 Sep 29.
PubMed 20883725Rose D, Delevoye-Turrell Y, Ott L, Annett LE, Lovatt PJ. Music and Metronomes Differentially Impact Motor Timing in People with and without Parkinson's Disease: Effects of Slow, Medium, and Fast Tempi on Entrainment and Synchronization Performances in Finger Tapping, Toe Tapping, and Stepping on the Spot Tasks. Parkinsons Dis. 2019 Aug 18;2019:6530838. doi: 10.1155/2019/6530838. eCollection 2019.
PubMed 31531220Repp BH, Su YH. Sensorimotor synchronization: a review of recent research (2006-2012). Psychon Bull Rev. 2013 Jun;20(3):403-52. doi: 10.3758/s13423-012-0371-2.
PubMed 23397235Repp BH, Keller PE. Adaptation to tempo changes in sensorimotor synchronization: effects of intention, attention, and awareness. Q J Exp Psychol A. 2004 Apr;57(3):499-521. doi: 10.1080/02724980343000369.
PubMed 15204138Repp BH. Sensorimotor synchronization: a review of the tapping literature. Psychon Bull Rev. 2005 Dec;12(6):969-92. doi: 10.3758/bf03206433.
PubMed 16615317Spencer RM, Ivry RB. Comparison of patients with Parkinson's disease or cerebellar lesions in the production of periodic movements involving event-based or emergent timing. Brain Cogn. 2005 Jun;58(1):84-93. doi: 10.1016/j.bandc.2004.09.010. Epub 2004 Nov 18.
PubMed 15878729Pinto SR, Uchida N. Tonic dopamine and biases in value learning linked through a biologically inspired reinforcement learning model. bioRxiv [Preprint]. 2023 Nov 29:2023.11.10.566580. doi: 10.1101/2023.11.10.566580.
PubMed 38014087O'Boyle DJ, Freeman JS, Cody FW. The accuracy and precision of timing of self-paced, repetitive movements in subjects with Parkinson's disease. Brain. 1996 Feb;119 ( Pt 1):51-70. doi: 10.1093/brain/119.1.51.
PubMed 8624694Merchant H, Luciana M, Hooper C, Majestic S, Tuite P. Interval timing and Parkinson's disease: heterogeneity in temporal performance. Exp Brain Res. 2008 Jan;184(2):233-48. doi: 10.1007/s00221-007-1097-7. Epub 2007 Sep 9.
PubMed 17828600
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhythm Psychophysics With Parkinson's Patients
- ClinicalTrials.gov ID
- NCT07647913
- Acronym / sponsor ID
- RPPD / 19513
- Conditions
- Parkinson Disease(PD)
- Keywords
- Parkinson Disease, PD, Rhythm, Sensorymotor synchronization, Perceptual timing, Motor timing, Interval timing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 15 Jun 2026 (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.
The goal of this interventional study is to understand how the rhythmic abilities of individuals in the early stages of Parkinson's Disease (PD) are impacted by their levels of dopamine. The main questions it aims to answer are:
- Does dopamine shelter the ability to generate and maintain a regular tapping rhythm in the presence of disrupting sensory information?
- Does dopamine allow the adaptation of tapping speed in the presence of changing sensory information?
- Is the engagement of the motor system useful to improve the detection of changes in the tempo of sensory information?
Participants will be asked to perform a battery of simple rhythmic tasks On and Off medication to evaluate the effect of dopamine on their rhythmic skills.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional within-subject non-therapeutic trial
| Arm | Type | Receives |
|---|---|---|
| Medication state | Experimental | Drug: Withholding LevodopaParticipants will have to attend two sessions scheduled approximately one week apart. During one session, participants will be tested while On medication (levodopa). During the other session, participants will be asked to withhold their medication for 12 hours prior to the experimental session. The order of the sessions will be randomized across participants. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parkinson's Disease diagnostic
- Stage 1 or 2 Hoenh-Yahr scale
- Taking immediate-release Levodopa
- MoCA score of 26 or above
Key exclusion criteria (5 listed)
- Dementia
- Other neurodegenerative disease
- History of substance abuse
- History of hearing disorders
- History of neuropsychiatric disease
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 |
|---|---|---|
| Withholding LevodopaParticipants will have to withhold Levodopa medication 12 h before one of two experimental sessions. | Drug | Medication state |
Primary outcome
Changes in mean inter-tap intervals following Levodopa withdrawal during rhythmic tapping tasks.
Time frame: Between experimental sessions one and two, which will take place approximately one week apart.
Audio recordings from the tapping tasks will be processed to extract onset times corresponding to participant taps (milliseconds). These onset times will be used to compute inter-tap intervals (ITI) by subtracting the earlier onset time from the later one (milliseconds).
Changes in constant error following Levodopa withdrawal during rhythmic tapping tasks.
Time frame: Between experimental sessions one and two, which will take place approximately one week apart.
Audio recordings from the tapping tasks will be processed to extract the onset times of participant taps (milliseconds). These onset times will be used to compute the constant error (milliseconds) by subtracting the base interval (milliseconds) from the mean inter-tap interval (milliseconds).
Changes in asynchronies following Levodopa withdrawal during rhythmic tapping tasks.
Time frame: Between experimental sessions one and two, which will take place approximately one week apart.
Audio recordings from the tapping tasks will be processed to extract onset times corresponding to auditory cues and participant taps (both in milliseconds). These onset times will be used to compute asynchronies (milliseconds) between the auditory cues and the taps. The asynchronies will be calculated by subtracting the tap onset from the corresponding auditory cue onset.
2 secondary outcomes
Impact of Levodopa withdrawal on motor symptoms severity scales.
Time frame: Between experimental Sessions one and two, which will take place approximately one week apart.
Impact of Levodopa withdrawal on motor symptoms severity scales.
Time frame: Between experimental sessions one and two, which will take place approximately one week apart.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 27760198Gratton I, Brandimonte MA, Bruno N. Absolute Memory for Tempo in Musicians and Non-Musicians. PLoS One. 2016 Oct 19;11(10):e0163558. doi: 10.1371/journal.pone.0163558. eCollection 2016.
- Background: PubMed 37718439Zhou ZD, Yi LX, Wang DQ, Lim TM, Tan EK. Role of dopamine in the pathophysiology of Parkinson's disease. Transl Neurodegener. 2023 Sep 18;12(1):44. doi: 10.1186/s40035-023-00378-6.
- Background: PubMed 30575431Yc K, Prado L, Merchant H. The scalar property during isochronous tapping is disrupted by a D2-like agonist in the nonhuman primate. J Neurophysiol. 2019 Mar 1;121(3):940-949. doi: 10.1152/jn.00804.2018. Epub 2018 Dec 21.
- Background: PubMed 18511305Witt ST, Laird AR, Meyerand ME. Functional neuroimaging correlates of finger-tapping task variations: an ALE meta-analysis. Neuroimage. 2008 Aug 1;42(1):343-56. doi: 10.1016/j.neuroimage.2008.04.025. Epub 2008 Apr 16.
- Background: PubMed 34521851Vishne G, Jacoby N, Malinovitch T, Epstein T, Frenkel O, Ahissar M. Slow update of internal representations impedes synchronization in autism. Nat Commun. 2021 Sep 14;12(1):5439. doi: 10.1038/s41467-021-25740-y.
- Background: PubMed 23772211van der Steen MC, Keller PE. The ADaptation and Anticipation Model (ADAM) of sensorimotor synchronization. Front Hum Neurosci. 2013 Jun 10;7:253. doi: 10.3389/fnhum.2013.00253. eCollection 2013.
- Background: PubMed 20883725Schwartze M, Keller PE, Patel AD, Kotz SA. The impact of basal ganglia lesions on sensorimotor synchronization, spontaneous motor tempo, and the detection of tempo changes. Behav Brain Res. 2011 Jan 20;216(2):685-91. doi: 10.1016/j.bbr.2010.09.015. Epub 2010 Sep 29.
- Background: PubMed 31531220Rose D, Delevoye-Turrell Y, Ott L, Annett LE, Lovatt PJ. Music and Metronomes Differentially Impact Motor Timing in People with and without Parkinson's Disease: Effects of Slow, Medium, and Fast Tempi on Entrainment and Synchronization Performances in Finger Tapping, Toe Tapping, and Stepping on the Spot Tasks. Parkinsons Dis. 2019 Aug 18;2019:6530838. doi: 10.1155/2019/6530838. eCollection 2019.
- Background: PubMed 23397235Repp BH, Su YH. Sensorimotor synchronization: a review of recent research (2006-2012). Psychon Bull Rev. 2013 Jun;20(3):403-52. doi: 10.3758/s13423-012-0371-2.
- Background: PubMed 15204138Repp BH, Keller PE. Adaptation to tempo changes in sensorimotor synchronization: effects of intention, attention, and awareness. Q J Exp Psychol A. 2004 Apr;57(3):499-521. doi: 10.1080/02724980343000369.
- Background: PubMed 16615317Repp BH. Sensorimotor synchronization: a review of the tapping literature. Psychon Bull Rev. 2005 Dec;12(6):969-92. doi: 10.3758/bf03206433.
- Background: PubMed 15878729Spencer RM, Ivry RB. Comparison of patients with Parkinson's disease or cerebellar lesions in the production of periodic movements involving event-based or emergent timing. Brain Cogn. 2005 Jun;58(1):84-93. doi: 10.1016/j.bandc.2004.09.010. Epub 2004 Nov 18.
- Individual participant dataSharing planned: Undecided
Related trials for Parkinson Disease(PD)
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Active, not recruitingPhase 2
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Carcinoma, Non-Small-Cell Lung
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.
Itzamna Sanchez Moncada, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Withholding Levodopa in people with Parkinson Disease(PD), run by McMaster University at 1 site in Canada.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 15 Jun 2026. 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 Canada. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Cannon, Dr ((905) 531-6902, cannoj9@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in mean inter-tap intervals following Levodopa withdrawal during rhythmic tapping tasks. (time frame: Between experimental sessions one and two, which will take place approximately one week apart.). The study lists 3 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 NCT07647913, which also lists 29 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 15 Jun 2026.