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Rhythm Psychophysics With Parkinson's Patients (RPPD)

9. juni 2026 opdateret af: McMaster University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

34

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4L8
        • Psychology Building
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Medication state
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.
Medicin: Withholding Levodopa
Participants will have to withhold Levodopa medication 12 h before one of two experimental sessions.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in mean inter-tap intervals following Levodopa withdrawal during rhythmic tapping tasks.
Tidsramme: 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).
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.
Tidsramme: 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).
Between experimental sessions one and two, which will take place approximately one week apart.
Changes in asynchronies following Levodopa withdrawal during rhythmic tapping tasks.
Tidsramme: 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.
Between experimental sessions one and two, which will take place approximately one week apart.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Impact of Levodopa withdrawal on motor symptoms severity scales.
Tidsramme: Between experimental Sessions one and two, which will take place approximately one week apart.
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.
Between experimental Sessions one and two, which will take place approximately one week apart.
Impact of Levodopa withdrawal on motor symptoms severity scales.
Tidsramme: Between experimental sessions one and two, which will take place approximately one week apart.
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.
Between experimental sessions one and two, which will take place approximately one week apart.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

McMaster University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

30. september 2027

Studieafslutning (Anslået)

31. oktober 2027

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 19513
  • RGEC27/2025 (Andet bevillings-/finansieringsnummer: Human Frontiers Science Program)

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

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Kliniske forsøg med Parkinsons sygdom (PD)

Kliniske forsøg med Withholding Levodopa

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Sponsorer og samarbejdspartnere

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Betingelser

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Placeringer

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