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Not yet recruiting NCT07647913

Rhythm Psychophysics With Parkinson's Patients

No phase Interventional Parkinson Disease(PD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Withholding Levodopa.
Who it may be relevant to
Registry conditions: Parkinson Disease(PD). Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Drug Withholding Levodopa
    Participants will have to withhold Levodopa medication 12 h before one of two experimental sessions.

Primary outcome measures

  • 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.]
  • 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.]
  • 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.]
Secondary outcome measures (2)
  • 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.]

Eligibility criteria

Inclusion criteria

  • Parkinson's Disease diagnostic
  • Stage 1 or 2 Hoenh-Yahr scale
  • Taking immediate-release Levodopa
  • MoCA score of 26 or above

Exclusion criteria

  • Dementia
  • Other neurodegenerative disease
  • History of substance abuse
  • History of hearing disorders
  • History of neuropsychiatric disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Canada · 1 center
  • Psychology Building — Hamilton

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. PMID 27760198
  • Zhou 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. PMID 37718439
  • Yc 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. PMID 30575431
  • Witt 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. PMID 18511305
  • Vishne 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. PMID 34521851
  • van 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. PMID 23772211
  • Schwartze 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. PMID 20883725
  • Rose 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. PMID 31531220

Identifiers

NCT: NCT07647913 · 19513 · RGEC27/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗