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NCT05505019 Clinical Trial

Targeting Apathy With Music in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:
The Role of a Personalized Music Intervention Towards Alleviating Apathy in Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05505019
Other study ID # H22-00905
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 9, 2022
Est. completion date October 1, 2025

Study information
Verified date March 2023
Source University of British Columbia
Contact Mikey Jose, B.Sc.
Phone (604) 822-3177
Email miguel.jose@ubc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Parkinson's Disease (PD) is often accompanied by non-motor symptoms that make treatment more difficult. One such symptom is apathy (lack of motivation and emotion). There are no treatments for apathy in PD, and this remains a major unmet need in PD patients. One possible way to target apathy in PD patients is listening to music, which has been shown to help improve apathy in older adults. Little work has explored the mechanism in which music targets apathy. Thus, the goal of this study is to understand how music listening can impact the brain towards decreasing apathy in PD patients.

Description:

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Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Music listening
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.
• Podcast listening
This intervention involves listening to participant-selected podcasts of neutral content. YouTube Music will be used to build both personalized music and podcast interventions.

Locations
Country Name City State
Canada Djavad Mowafghian Centre for Brain Health Vancouver British Columbia

Sponsors (2)
Lead Sponsor Collaborator
University of British Columbia Northeastern University

Country where clinical trial is conducted

Canada, 

References & Publications (47)

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Outcome
Type Measure Description Time frame Safety issue
Other Clinical assessment for overall cognition - Montreal Cognitive Assessment (MoCA) 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. 0 weeks (baseline)
Other Clinical assessment for depressive symptoms (not diagnostic) - Beck's Depression Inventory (BDI) 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)
Other Validated assessment of musical perception (contour subtest) - Montreal Battery of Evaluation of Amusia (MBEA); 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. 0 weeks (baseline)
Other Clinical assessment of overall reward/pleasure sensitivity - Snaith-Hamilton Pleasure Scale (SHAPS) 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. 0 weeks (baseline)
Other White matter tract - axial diffusivity; lesion analysis in white matter tracts (focus on arcuate fasciculus) diffuse tensor image (DTI) 8 weeks
Other White matter tracts; lesion analysis in white matter tracts (focus on arcuate fasciculus) diffuse tensor image (DTI) 8 weeks
Primary 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 fMRI - task-based functional magnetic resonance imaging 8 weeks
Primary 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 rsfMRI - resting state functional magnetic resonance imaging 8 weeks
Primary Change in univariate whole-brain analysis at rest before and after an 8-week audio-based intervention 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 8 weeks
Primary Change in univariate whole-brain analysis during a music listening task before and after an 8-week audio-based intervention 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
Primary Change in fMRI representational similarity analysis during a music listening task before and after an 8-week audio-based intervention 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
Primary Change in fMRI representational similarity analysis at rest before and after an 8-week audio-based intervention 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 8 weeks
Primary Short-term clinical measure of apathy before and after an 8-week audio-based intervention -Positive and Negative Affective Schedule (PANAS) 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. 8 weeks
Primary Short-term clinical measure of apathy after a 4-week washout period post-intervention - Positive and Negative Affective Schedule (PANAS) 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. 4 weeks
Primary Short-term clinical measure of apathy before and after an 8-week audio-based intervention - Visual Analogue Scale (VAS) 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. 8 weeks
Primary Short-term clinical measure of apathy after a 4-week washout period post-intervention - Visual Analogue Scale (VAS) 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. 4 weeks
Primary Long-term clinical measure of apathy before and after an 8-week audio-based intervention - Starkstein Apathy Scale (SAS) 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. 8 weeks
Primary Long-term clinical measure of apathy after a 4-week washout period post-intervention - Starkstein Apathy Scale (SAS) 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. 4 weeks
Primary Clinical assessment of apathy before and after an 8-week audio-based intervention - Lille Apathy Rating Scale (LARS) 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. 8 weeks
Primary Clinical assessment of apathy after a 4-week washout period post-intervention - Lille Apathy Rating Scale (LARS) 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. 4 weeks
Primary 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) 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. 8 weeks
Primary 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 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. 4 weeks
Primary Assessment of musical reward sensitivity before and after an 8-week audio-based intervention - Barcelona Musical Reward Questionnaire (BMRQ) 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
Primary Assessment of musical reward sensitivity after a 4-week washout period post-intervention - Barcelona Musical Reward Questionnaire (BMRQ) 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. 4 weeks
Primary Grip force response (GFR) during a music listening fMRI task before and after an 8-week audio-based intervention GFR is a physical effort measure; it is a validated measure of apathy in Parkinson's Disease (Zhu et al., 2021) 8 weeks
Primary Grip force duration and fatigue during a music listening fMRI task before and after an 8-week audio-based intervention Grip force duration and fatigue are physical effort measures; they are validated measures of apathy in Parkinson's Disease (Zhu et al., 2021) 8 weeks
Secondary 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 Quality of Life Scale (QOLS) 8 weeks
Secondary White and grey matter distribution T1-weighted magnetic resonance image (MRI) 8 weeks
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