Cognitive Health Research on Musical Arts

NCT04137913 | Completed

• 1 other identifier: IRB-FY2019-355
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to assess the therapeutic effect that music creativity engagement has on cognition and social/emotional well-being, with a special interest in quantifying the associated connectivity changes in the brain. Investigators will measure the effect that a creative music intervention has on health-related outcomes for mild cognitive impairment (MCI) patients using novel neural markers, laboratory-based cognitive tasks, assessments of loneliness, perceptions of stress, and social support.

Conditions

Cognitive Impairment; Creativity

Keywords

mild cognitive impairment; musical arts; whole brain network; cognition; aging

Outcome Measures

Primary Outcomes (9)

• Change from baseline in functional resting state brain activity at follow-up visit.

  Modularity and flexibility will act as quantifiers of neural activity. Modularity is the degree to which neural activity within a group of brain regions is more highly correlated than is activity between such groups, and flexibility is the dynamic reorganization of these groups.

  Functional magnetic resonance imaging will be obtained at enrollment and within one month since the completion of the music course.

• Mean change from baseline in level of creativity using scores on Guilford's alternative Uses Divergent Thinking Test

  Total scores are derived based on fluency, flexibility, originality, and elaboration. Higher scores indicate greater creativity. There is no max score.

  Creativity will be measured at enrollment and within one month since the completion of the music course.

• Mean change in scores from baseline in perceived social support subscales of the Medical Outcomes Studies, including emotional support, tangible support, affectionate support, and positive social interactions.

  Scores are transformed to a 0-100 scale. Higher scores on the self-report social support scale indicate a larger degree of perceived social support in each of these domains: emotional support, tangible support, affectionate support, and positive social interaction.

  Creativity will be measured at enrollment and within one month since the completion of the music course.

• Mean change from baseline in quality of life scores each subscale of the SF-36

  Eight subscales measuring quality of life are scored out of 100. These subscales include: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general and health. Lower scores indicate greater disability.

  Quality of life will be measured at enrollment and within one month since the completion of the music course.

• Mean change from baseline in inhibition and inhibition/switching trials on the color-word interference test of the Delis Kaplan Executive Function System (DKEFS)

  Higher scores for inhibition and inhibition/switching trials indicate greater executive functioning. Scaled and raw scores will be assessed. There is no minimum and maximum score.

  Cognitive scores will be measured at enrollment and within one month since the completion of the music course.

• Mean change from baseline in cognitive scores (digit span forward, digit span backward, digit span sequencing, and total raw score) on the digit span test of the Wechsler Adult Intelligence Scale (WAIS).

  Higher scores indicate greater working memory ability. Each subscale (forward, backward, and sequencing) has a maximum score of 16. The maximum total raw score is 48.

  Cognitive scores will be measured at enrollment and within one month since the completion of the music course.

• Mean change from baseline in perseverative errors on the Wisconsin Card Sorting Test (WCST)

  The Wisconsin Card Sorting Test assess executive control. Scores on the WCST are based on percentages of categories achieved, errors, and perseveration errors. Greater number of perseverative errors indicate poorer executive control.

  Cognitive scores will be measured at enrollment and within one month since the completion of the music course.

• Mean change from baseline in affect scores on the Positive and Negative Affect Scale

  Two scales measuring positive and negative affect. Scores range from 10-50 on each scale. Higher scores on positive affect scale indicate higher levels of positive affect. Lower scores on the negative affect scale indicate lower levels of negative affect.

  Daily affect scores will be measured for 7 days after enrollment and 7 days after the final follow-up visit that will take place within 1 month after the completion of the music course.

• Mean change from baseline in emotion regulation scores on the Emotional Regulation Scale

  The self-report questionnaire measures the extent to which one uses cognitive appraisal or suppression techniques to regulate emotions. Higher scores on each subscale indicate greater use of that regulation strategy. Scores are continuous. The emotional reappraisal scale has a max score of 42. The emotional suppression scale has a max score of 28.

  Emotion regulation scores will be measured at enrollment and at the follow-up visit that will take place within one month after the completion of the music course.

Secondary Outcomes (1)

• Mean change in inflammation from enrollment (baseline) to follow-up visit

  Blood will be drawn at enrollment and within one month after the completion of the music study (for experimental group).

Study Arms (2)

Music Group

EXPERIMENTAL

Individuals in the music group will complete two assessment visit (pre-intervention and post-intervention). After their baseline visit, they will participate in a 6-week group music class, scheduled for 2 hours a day, 3 days a week. The daily music workshops will be led by a musician associated with the Rice Shepherd School of Music. Each week will be carefully scaled in difficulty, with the workshops becoming progressively more sophisticated. For instance, the first week's listening will focus on short and more familiar works such as instrumental etudes and folk songs. Gradually, the instructor will build towards symphonic movements, as well as more unfamiliar and experimental music. The course will culminate in creating a final composition.

Behavioral: Musical arts intervention

Non-music group

NO INTERVENTION

Individuals in the non-music group will complete two assessment visits separated by 2-3 months. They will be asked not to participate in any other music-related courses during the time they are enrolled in the study. At the end of participation, participants will be given resources to seek out music classes.

Interventions

Musical arts intervention BEHAVIORAL

A 6-week group music class that incorporates listening, theory, performance, and creation of music.

Music Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over the age of 70, unless diagnosed with early to moderate mild cognitive impairment (self-described and confirmed by physician).
• Able to read and write in English
• Cognitively competent to participate (i.e. correctly answers three questions to confirm comprehension of participation)
• Demonstrate ability to follow instructions

You may not qualify if:

• Below the age of 70 and not diagnosed with MCI.
• Significant visual or auditory impairment resulting in the inability to read and/or hear the questionnaires
• Class III heart failure
• Autoimmune and/or inflammatory disorders
• Any implanted medical device that renders one unable to undergo fMRI scanning
• Pregnant or nursing women
• Weight \> 300lb or BMI over 40
• Professional musician
• Comorbid diagnosis of Parkinson's Disease
• Dental implants or extensive dental work that impedes collection of good-quality fMRI data

Sponsors & Collaborators

• William Marsh Rice University: lead
• National Endowment for the Arts, United States: collaborator
• The Methodist Hospital Research Institute: collaborator

Study Sites (1)

Rice University Bioscience Research Collaborative

Houston, Texas, 77030, United States

Location

Related Publications (121)

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Related Links

• The Rice Arts, Cognition, and Health Science Initiative website.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Christopher P Fagundes, Ph.D.

  William Marsh Rice University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Due to limited funding, the research team is unable to conduct a truly randomized clinical trial. Research staff assessing baseline assessment (pre-intervention) and follow-up assessments (post-intervention) will not be intentionally masked. Participants also will not be masked. During the screening process, participants are told that they are randomized into a certain group: creative music and creative reading.They are informed which group they have been assigned to at their baseline visit because each group requires a different time commitment (music: requires coming in 3x a week for 6 weeks. reading/control: doesn't involve extra time commitment outside of the two research visits).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Half the participants will be placed in the experimental group while the other half will be placed in the non wait-list control group (termed creative reading group to participants). Individuals in the control group will not be given the music intervention during their enrollment in the study. Due to the lack of funds, the research team is unable to provide individuals in the control group with the intervention after the study. Participants in the control group will be told that they have been placed in the creative reading group. They will receive a creativity book to read at the completion of their last visit. A post-study survey will be sent to the control group to minimize the possibility that control participants know that they're in the control group.

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 24, 2019
• Study Start: November 19, 2019
• Primary Completion: November 10, 2022
• Study Completion: June 15, 2023
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)