Targeting Apathy With Music in Parkinson's Disease

NCT05505019 | Recruiting

• 1 other identifier: H22-00905
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Apathy

Keywords

Music; Music intervention; Non-motor symptoms

Outcome Measures

Primary Outcomes (20)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• 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

  8 weeks

• White and grey matter distribution

  8 weeks

Other Outcomes (6)

• Clinical assessment for overall cognition - Montreal Cognitive Assessment (MoCA)

  0 weeks (baseline)

• Clinical assessment for depressive symptoms (not diagnostic) - Beck's Depression Inventory (BDI)

  0 weeks (baseline)

• Validated assessment of musical perception (contour subtest) - Montreal Battery of Evaluation of Amusia (MBEA);

  0 weeks (baseline)

Study Arms (2)

Parkinson's Disease with apathy - Music-listening

EXPERIMENTAL

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".

Other: Music listening

Parkinson's Disease with apathy - Podcast-listening

EXPERIMENTAL

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".

Other: Podcast listening

Interventions

Music listening OTHER

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.

Parkinson's Disease with apathy - Music-listening

Podcast listening OTHER

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

Parkinson's Disease with apathy - Podcast-listening

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Clinical diagnosis of Parkinson's Disease following MDS Parkinson's disease criteria

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead
• Northeastern University: collaborator

Study Sites (1)

Djavad Mowafghian Centre for Brain Health

Vancouver, British Columbia, V6T1Z3, Canada

RECRUITING

Related Publications (47)

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MeSH Terms

Conditions

Parkinson Disease; Lethargy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mikey Jose, B.Sc.

CONTACT

(604) 822-3177; miguel.jose@ubc.ca

Annie Kuan

CONTACT

604-827-0576; annie.kuan@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: A randomization schedule will be designed by the research coordinator (MJ) and only the research coordinator will know the group allocations. If any experimental condition is shown to be harmful to any participant and it is medically crucial for a participant to know which intervention group they are in, the research coordinator will break code and disclose this information to the participant.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants with Parkinson's Disease (PD) and apathy will be randomly assigned to one of two experimental groups: 1) A music-listening group, and 2) a podcast-listening group.

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: August 17, 2022
• Study Start: February 9, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

CA (1)