Clinical trial NCT06721390: Music Improvisation Training on Cognitive Function in Older Adults
Official title: Impact of Music Improvisation Training on Cognitive Function in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Cognitive Aging
Cognitive Impairment
Cognitive Training
Mild Cognitive Impairment
Cognitively Normal Older Adults
Keywords: Aging
Brain Aging
Cognition
Cognitive Engagement
Mild Cognitive Impairment
Music
Music-based Intervention
Music Training
Older Adults
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-12-06
Enrollment: 238
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment - We will conduct a 2-arm randomized controlled trial.
Primary purpose: OTHER

Brief summary: This project will study the effects and mechanisms of a music improvisation training intervention on self-regulation of older adults with and without MCI. The investigator's overall hypothesis is that improvisation training will lead to improvements in self-regulation, compared to controls, and that improvisation training will be associated with specific changes in prefrontal brain networks and ultimately cognitive engagement.

Detailed description: Approximately 5.8 million adults age 60 and over in the United States live with Alzheimer disease and related dementias (AD/ADRD) at a cost of $290 billion per year. Older adults with mild cognitive impairment (MCI), an intermediate stage between typical aging and dementia, are 3-5 times more likely to progress to AD than those with normal cognition. Late-life engagement in cognitively challenging activities is associated with decreased risk of cognitive decline, and there is a need to address cognitive inactivity. Music interventions are a promising strategy to address late-life cognitive inactivity. Music training can change brain structure and function in non-musician adults, thereby leading to cognitive, perceptual, and psychosocial advantages. These changes in cognitive function are thought to occur because the multimodal, complex nature of music facilitates training-induced neural plasticity. However, the mechanisms are not yet understood, and most studies used traditional or rote keyboard training techniques. Music training based on improvisation principles-the spontaneous generation of musical melodies and rhythms-will likely have more potent effects on cognition and brain function. Improvisation facilitates cognitive flexibility, self-monitoring, novel idea generation, execution of unplanned motor sequences and entrance into a state of flow. Biologically, improvisation is associated with distinct neural patterns involving activation of prefrontal networks and other brain networks that are affected by aging. As a mechanism of behavior change, it is likely that improvisation training will uniquely improve self-regulation (the ability to monitor and control one's own behavior, emotions, or thoughts and modify to situational demands). Yet, no research has tested whether improvisation training can improve self-regulation and facilitate maintenance of cognitively challenging activities among older adults with and without MCI. This project will develop and test the effects and mechanisms of a music improvisation training intervention on self-regulation of older adults with and without MCI. Our overall hypothesis is that improvisation training will lead to improvements in self-regulation, compared to controls, and that improvisation training will be associated with specific changes in prefrontal brain networks and ultimately cognitive engagement. Our project has two phases. In the R61 phase, the study will develop a music improvisation training intervention that aims to improve self-regulation among older adults with and without MCI and conduct a 2-arm randomized pilot study to (i) examine feasibility and acceptability of the intervention and study methods and (ii) determine its effects on the hypothesized mechanism of self-regulation. If milestones are met, the study will proceed to the R33 phase and conduct a randomized mechanistic trial to examine the effects of the intervention, compared to an attention control, on self-regulation and cognitive engagement among older adults with and without MCI. The findings from this study will improve our understanding of the underlying mechanisms of how music training interventions can facilitate behavior change to maintain health of older adults.

Eligibility criteria: Inclusion Criteria:

* Age 60 and over
* Living independently in the community
* Sufficient visual and hearing acuity (age-related to normal hearing loss, with assistive devices) as measured by audiometer
* Less than three years of formal music training (as indicated by private music lessons does not include group or ensemble classes) and not currently reading or engaging in music performance
* English fluency rated fairly well to well
* MoCA score of 22-30 or diagnosis of "mild cognitive impairment
* Not currently taking psychoactive medications, antidepressants, or sleep medications that could adversely affect cognitive abilities.

Exclusion Criteria:

* Medical diagnosis of dementia (any etiology)
* Inability to move the hands or use all 10 digits (extensive arthritis, neuropathy, missing digits)
* Score \< 22 on MoCA
* Current (but not prior) severe psychiatric disorder, serious medical condition (e.g., stroke, TIA) that would interfere with participation in the study
* Poor English fluency
* Musician or previously trained in jazz improvisation, more than three years of formal music instruction or training and/or currently engaged in musical performance
* Plans to move out of the area within six months

Primary outcomes:
measure: Florida Cognitive Activities Scale
timeFrame: Baseline and 12-week Post Intervention
measure: Short Self Regulatory Questionnaire
timeFrame: Baseline and 12-week Post Intervention
Secondary outcomes:
measure: National Institutes of Health ToolBox Self-Efficacy
timeFrame: Baseline and 12-week Post Intervention
measure: Short GRIT Scale
timeFrame: Baseline and 12-week Post Intervention
measure: Five Facets of Mindfulness
timeFrame: Baseline and 12-week Post Intervention
measure: National Institutes of Health Toolbox Loneliness Scale
timeFrame: Baseline and 12-week Post Intervention
measure: National Institutes of Health Toolbox Apathy
timeFrame: Baseline and 12-week Post Intervention
measure: Geriatric Depression Scale - Short Form
timeFrame: Baseline and 12-week Post Intervention
measure: 10-item Personality Inventory
timeFrame: Baseline and 12-week Post Intervention
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Potrero Hill Neighborhood House
state: California
city: San Francisco
country: United States
facility: Dr. George W. Davis Senior Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Julene Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References: