- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05505019
Targeting Apathy With Music in Parkinson's Disease
The Role of a Personalized Music Intervention Towards Alleviating Apathy in Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Apathy is a common neuropsychiatric disturbance that manifests in approximately a quarter of patients in early stages of Parkinson's Disease (PD) and becomes more prevalent over disease progression and cognitive decline. Apathy in PD has been categorized as a distinct behavioural syndrome which can be differentiated from depression and anxiety, and is independently associated with lower functioning in daily life, decreased treatment response, and worse quality of life compared with PD patients without apathy. Characterized by a dysfunction in motivation, or lack of self-initiated goal-directed actions, apathy in PD has been hypothesized to stem from dysfunction in goal-directed reward-seeking networks that rely on dopaminergic transmission in the mesocorticolimbic and frontostriatal pathways, which includes the striatum (includes the nucleus accumbens, or NAc), prefrontal cortex (PFC), hippocampus, and amygdala. Pharmacological trials have attempted to target apathy through the neurotransmitter systems with limited success and sometimes adverse effects. The treatment of apathy remains a major unmet need in PD; thus, it is crucial to develop therapeutic interventions targeting apathy in PD and better understand the underlying mechanisms that may lead to apathy.
Evidence of the positive effects of music-based interventions (MBIs) in both healthy aging and clinical geriatric populations has been examined extensively across the literature. The positive effects of MBIs on alleviating apathy and increasing motivation have been reported in studies focusing on several clinical populations, such as dementia, autism spectrum disorder, and patients undergoing cardiac rehabilitation. A major gap in the MBI clinical trials literature is the lack of attention on the underlying mechanisms in which music can carry out its effects, especially regarding reward pathways. Dysfunction in the reward pathways, which involve the striatum, limbic system, and prefrontal cortices, underlie many disorders, symptoms, and syndromes, and elucidating the role of this underlying network with music is important towards understanding how music can mediate reward deficiencies, such as apathy. Understanding how music works to improve brain functioning is a key gap in understanding how to best inform the development of new therapies and interventions.
Recent work in functional, neurochemical, and pharmacological studies have helped elucidate the role of music in activating reward pathways. Namely, the nucleus accumbens (NAc) has been shown to be involved with processing peak emotionally arousing musical experiences, such as the "chills", and subjective valuations from music. Dopamine transmission in the ventral and dorsal striatum is implicated in regulating this process determined through positron emission tomography (PET) imaging. This work has established the role that the NAc and striatum, and dopaminergic transmission play in processing reward from music and its effects on aspects of cognition, such as motivation, learning, and memory. Thus, the effects of music may be able to mediate the underlying reward system that is compromised in PD patients.
More recently, connectivity between reward and auditory circuits, which include the superior temporal gyrus (STG), superior temporal sulcus (STS) and Heschl's gyrus (HG), have been implicated in musical reward processing and evaluation. No studies to date have observed the immediate and long-term effects of rewarding music on the implicated auditory-reward circuitry and action-oriented behaviour. Thus, this study aims to examine the immediate and longitudinal effects of participant-evaluated rewarding music on clinical apathy measures, connectivity in the auditory-reward networks, and effortful activity in PD patients with and without apathy.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mikey Jose, B.Sc.
- Phone Number: (604) 822-3177
- Email: miguel.jose@ubc.ca
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6T1Z3
- Recruiting
- Djavad Mowafghian Centre for Brain Health
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Contact:
- Annie Kuan
- Phone Number: (604) 822-1388
- Email: annie.kuan@ubc.ca
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of Parkinson's Disease following MDS Parkinson's disease criteria
Exclusion Criteria:
- Participants with atypical Parkinsonism (eg. Progressive supranuclear palsy, multiple system atrophy, drug induced, etc.)
- Epilepsy
- Other neurological disease/complications (eg. myopathy, stroke, brain lesion, MS)
- Significant cognitive impairment (MoCa <21)
- Moderate depression (Beck's Depression Inventory >20)
- Severe/multiple head trauma(s)
- Participants with metal/medical implants, including any of the following: artificial heart valve, brain aneurysm clip, electrical stimulators, ear or eye implant, implanted drug infusion pump, coil, catheter, or filter in any blood vessel, orthopedic hardware such as artificial joint, plate, and/or screws, other metallic prostheses, shrapnel, bullets, or other metal fragments, surgery or tattoos, including tattooed eyeliner, in the last six weeks, cardiac pacemaker, wires or defibrillator, or ferromagnetic aneurysm clip)
- Participants who have gone through specific injuries/brain surgery (eg. an injury where a piece of metal lodged in the eye or orbit)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Parkinson's Disease with apathy - Music-listening
Participants in this arm will receive a YouTube account app to use.
Prior to the start of the intervention, a research team member will guide participants in this group in constructing a playlist of music that they "find rewarding or motivating".
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This intervention involves listening to participant-selected music that they have evaluated as rewarding/motivating. YouTube Music will be used to build both personalized music and podcast interventions.
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Experimental: Parkinson's Disease with apathy - Podcast-listening
Participants in this arm will receive a YouTube account app to use.
Prior to the start of the intervention, a research team member will guide participants in this group in choosing a podcast that they "find rewarding or motivating".
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This intervention involves listening to participant-selected podcasts of neutral content.
YouTube Music will be used to build both personalized music and podcast interventions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in seed-based functional connectivity between auditory, reward, and motor areas (implicated in musical reward processing) during a music-listening task, before and after an 8-week audio-based intervention
Time Frame: 8 weeks
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fMRI - task-based functional magnetic resonance imaging
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8 weeks
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Change in seed-based functional connectivity between auditory, reward, and motor areas (implicated in musical reward processing) at rest, before and after an 8-week audio-based intervention
Time Frame: 8 weeks
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rsfMRI - resting state functional magnetic resonance imaging
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8 weeks
|
Change in univariate whole-brain analysis at rest before and after an 8-week audio-based intervention
Time Frame: 8 weeks
|
rsfMRI - resting state functional magnetic resonance imaging; observing activity across the brain and in specific regions of interest (ROIs), including reward, auditory, and motor areas
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8 weeks
|
Change in univariate whole-brain analysis during a music listening task before and after an 8-week audio-based intervention
Time Frame: 8 weeks
|
fMRI - task-based functional magnetic resonance imaging; observing activity across the brain and in specific regions of interest (ROIs), including reward, auditory, and motor areas
|
8 weeks
|
Change in fMRI representational similarity analysis during a music listening task before and after an 8-week audio-based intervention
Time Frame: 8 weeks
|
fMRI - task-based functional magnetic resonance imaging; observing correlated BOLD (blood oxygen level dependent) activity across the brain and in specific regions of interest (ROIs), including reward, auditory, and motor areas
|
8 weeks
|
Change in fMRI representational similarity analysis at rest before and after an 8-week audio-based intervention
Time Frame: 8 weeks
|
rsfMRI - resting state functional magnetic resonance imaging; observing correlated BOLD (blood oxygen level dependent) activity across the brain and in specific regions of interest (ROIs), including reward, auditory, and motor areas
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8 weeks
|
Short-term clinical measure of apathy before and after an 8-week audio-based intervention -Positive and Negative Affective Schedule (PANAS)
Time Frame: 8 weeks
|
The PANAS is a self-reported 20-item scale with 2 major subscales: Positive affect score and Negative affect score.
Items are scored on a scale of 1-5.
Scores range from 10-50 for both the Positive and Negative Affect, with higher scores representing higher levels of Positive/Negative affect.
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8 weeks
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Short-term clinical measure of apathy after a 4-week washout period post-intervention - Positive and Negative Affective Schedule (PANAS)
Time Frame: 4 weeks
|
The PANAS is a self-reported 20-item scale with 2 major subscales: Positive affect score and Negative affect score.
Items are scored on a scale of 1-5.
Scores range from 10-50 for both the Positive and Negative Affect, with higher scores representing higher levels of Positive/Negative affect.
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4 weeks
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Short-term clinical measure of apathy before and after an 8-week audio-based intervention - Visual Analogue Scale (VAS)
Time Frame: 8 weeks
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The VAS is a visual scale with a rating from 1-10; participants are to indicate the level of apathy and motivation felt at their current state.
Higher values indicate more severe apathy.
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8 weeks
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Short-term clinical measure of apathy after a 4-week washout period post-intervention - Visual Analogue Scale (VAS)
Time Frame: 4 weeks
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The VAS is a visual scale with a rating from 1-10; participants are to indicate the level of apathy and motivation felt at their current state.
Higher values indicate more severe apathy.
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4 weeks
|
Long-term clinical measure of apathy before and after an 8-week audio-based intervention - Starkstein Apathy Scale (SAS)
Time Frame: 8 weeks
|
The SAS is a 14-item clinical scale used to evaluate apathy in clinical populations.
Higher scores indicate more severe apathy.
Scores range from 0-42.
Participants who score >=14 are considered as having clinical apathy.
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8 weeks
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Long-term clinical measure of apathy after a 4-week washout period post-intervention - Starkstein Apathy Scale (SAS)
Time Frame: 4 weeks
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The SAS is a 14-item clinical scale used to evaluate apathy in clinical populations.
Higher scores indicate more severe apathy.
Scores range from 0-42.
Participants who score >=14 are considered as having clinical apathy.
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4 weeks
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Clinical assessment of apathy before and after an 8-week audio-based intervention - Lille Apathy Rating Scale (LARS)
Time Frame: 8 weeks
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The LARS is a 33-item assessment with 9 subscales: everyday productivity, interests, taking the initiative, novelty seeking, motivation - voluntary actions, emotional responses, concern, social life, and self-awareness.
There is a mix of open-ended (items scored between -2 and 2) and multiple choice items (items scored between -1 and 1).
Scores range from -36 to 36.
Higher scores indicate more severe apathy.
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8 weeks
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Clinical assessment of apathy after a 4-week washout period post-intervention - Lille Apathy Rating Scale (LARS)
Time Frame: 4 weeks
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The LARS is a 33-item assessment with 9 subscales: everyday productivity, interests, taking the initiative, novelty seeking, motivation - voluntary actions, emotional responses, concern, social life, and self-awareness.
There is a mix of open-ended (items scored between -2 and 2) and multiple choice items (items scored between -1 and 1).
Scores range from -36 to 36.
Higher scores indicate more severe apathy.
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4 weeks
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Clinical assessment of apathy in Parkinson's Disease before and after an 8-week audio-based intervention - Movement Disorders Society Unified Parkinson's Disease Rating Scale - apathy item (MDS-UPDRS)
Time Frame: 8 weeks
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The MDS-UPDRS is a clinical assessment of motor and non-motor symptoms in individuals with Parkinson's Disease.
It consists of four subscales.
Subscales 1, 3, and 4 are administered by a trained individual with subscale 2 being self reported.
Each item is rated from 0 to 4.
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8 weeks
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Clinical assessment of apathy in Parkinson's Disease after a 4-week washout period post-intervention - Movement Disorders Society Unified Parkinson's Disease Rating Scale - apathy item
Time Frame: 4 weeks
|
The MDS-UPDRS is a clinical assessment of motor and non-motor symptoms in individuals with Parkinson's Disease.
It consists of four subscales.
Subscales 1, 3, and 4 are administered by a trained individual with subscale 2 being self reported.
Each item is rated from 0 to 4.
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4 weeks
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Assessment of musical reward sensitivity before and after an 8-week audio-based intervention - Barcelona Musical Reward Questionnaire (BMRQ)
Time Frame: 8 weeks
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The BMRQ is a validated 20-item assessment of musical reward sensitivity (how responsive a participant is to the rewarding effects of music listening).
It has 5 subscales: musical seeking, emotion evocation, mood regulation, social reward, and sensory-motor.
Items are scored from 1-5.
Higher scores indicate higher sensitivity to reward.
|
8 weeks
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Assessment of musical reward sensitivity after a 4-week washout period post-intervention - Barcelona Musical Reward Questionnaire (BMRQ)
Time Frame: 4 weeks
|
The BMRQ is a validated 20-item assessment of musical reward sensitivity (how responsive a participant is to the rewarding effects of music listening).
It has 5 subscales: musical seeking, emotion evocation, mood regulation, social reward, and sensory-motor.
Items are scored from 1-5.
Higher scores indicate higher sensitivity to reward.
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4 weeks
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Grip force response (GFR) during a music listening fMRI task before and after an 8-week audio-based intervention
Time Frame: 8 weeks
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GFR is a physical effort measure; it is a validated measure of apathy in Parkinson's Disease (Zhu et al., 2021)
|
8 weeks
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Grip force duration and fatigue during a music listening fMRI task before and after an 8-week audio-based intervention
Time Frame: 8 weeks
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Grip force duration and fatigue are physical effort measures; they are validated measures of apathy in Parkinson's Disease (Zhu et al., 2021)
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8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical assessment for Quality of Life before and after an 8-week audio-based intervention - Quality of Life Scale (QOLS); observing if the intervention improves QoL measures
Time Frame: 8 weeks
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Quality of Life Scale (QOLS)
|
8 weeks
|
White and grey matter distribution
Time Frame: 8 weeks
|
T1-weighted magnetic resonance image (MRI)
|
8 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical assessment for overall cognition - Montreal Cognitive Assessment (MoCA)
Time Frame: 0 weeks (baseline)
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The MoCA is a researcher-administered 30-item assessment covering 8 aspects of cognition: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation.
Scores range from 0-30.
Higher scores indicate better cognition; lower scores indicate poorer cognition.
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0 weeks (baseline)
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Clinical assessment for depressive symptoms (not diagnostic) - Beck's Depression Inventory (BDI)
Time Frame: 0 weeks (baseline)
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The BDI is a self reported 21-question multiple-choice self-report inventory on a scale from 0-3.
Scores range from 0-63.
Higher scores indicate higher levels of depression; scores over 40 are considered as extreme depression.
It will be used as a screening tool to observe any overlap between apathy and depression.
|
0 weeks (baseline)
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Validated assessment of musical perception (contour subtest) - Montreal Battery of Evaluation of Amusia (MBEA);
Time Frame: 0 weeks (baseline)
|
The Montreal Battery of Evaluation of Amusia (MBEA) measures level of general music perception for universal musical structures.
This will be used to rule out any non-effects of the music intervention due to a deficit in musical perception abilities; the contour subtest will be used to evaluate this.
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0 weeks (baseline)
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Clinical assessment of overall reward/pleasure sensitivity - Snaith-Hamilton Pleasure Scale (SHAPS)
Time Frame: 0 weeks (baseline)
|
The SHAPS will be used to compare with BMRQ to isolate for overall anhedonia/apathy versus music-specific apathy (Loui and Belfi, 2020).
Higher scores correlate with higher apathy/less pleasure.
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0 weeks (baseline)
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White matter tract - axial diffusivity; lesion analysis in white matter tracts (focus on arcuate fasciculus)
Time Frame: 8 weeks
|
diffuse tensor image (DTI)
|
8 weeks
|
White matter tracts; lesion analysis in white matter tracts (focus on arcuate fasciculus)
Time Frame: 8 weeks
|
diffuse tensor image (DTI)
|
8 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
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- Zhu M, HajiHosseini A, Baumeister TR, Garg S, Appel-Cresswell S, McKeown MJ. Altered EEG alpha and theta oscillations characterize apathy in Parkinson's disease during incentivized movement. Neuroimage Clin. 2019;23:101922. doi: 10.1016/j.nicl.2019.101922. Epub 2019 Jul 2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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Other Study ID Numbers
- H22-00905
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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