Rhythm Psychophysics With Parkinson's Patients
ConditionParkinson Disease(PD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorMcMaster University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Parkinson's Disease diagnostic
Stage 1 or 2 Hoenh-Yahr scale
Taking immediate-release Levodopa
MoCA score of 26 or above
Disqualifiers
Dementia
Other neurodegenerative disease
History of substance abuse
History of hearing disorders
Trial design
Design model
Single group
Treatments tested in this trial
Withholding Levodopa
DrugParticipants will have to withhold Levodopa medication 12 h before one of two experimental sessions.
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: Medication stateExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Between experimental sessions one and two, which will take place approximately one week apart.2
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).
Time frame
Between experimental sessions one and two, which will take place approximately one week apart.3
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.
Time frame
Between experimental sessions one and two, which will take place approximately one week apart.Secondary outcomes
1
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.
Time frame
Between experimental Sessions one and two, which will take place approximately one week apart.2
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.
Time frame
Between experimental sessions one and two, which will take place approximately one week apart.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: