CHROMA: Cognitive Health Research on Musical Arts

Sponsor

William Marsh Rice University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04137913

Collaborator

Methodist Research Institute: Center for Performing Arts Medicine (Other), National Endowment for the Arts, United States (U.S. Fed), Musiqa (Other)

Enrollment

Location

Arms

23.1

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Impairment Creativity	Behavioral: Musical arts intervention	N/A

Detailed Description

General outline:

All eligible participants who choose to participate in this study will be asked to complete one baseline visit and one follow-up visit. MCI participants will be randomly assigned to either the experimental group (music group) or control group (non-music group) when their study enrollment is confirmed.

The study may take place at different locations depending on assessments. Screening assessments will take place over the phone and in-person with a research staff member. Baseline and follow-up assessments will take place on campus at the Bioscience Research Collaborative (BRC) and at the Methodist Research Institute-Translational Imaging Center.

Assessment visits. Interested individuals will complete the first visit for a baseline blood draw, health assessments, cognitive and behavioral tasks, and social and emotional well-being assessments at Rice University's BioScience Research Collaborative (BRC) building, Suite 140. Participants will transport themselves or be brought to the BRC building by their caregiver or family member. Baseline and follow-up neuroimaging will be performed at Methodist Research Institute-Translational Imaging Center. Additionally, the social, physical, and emotional wellbeing of the participant and the caregiver (if present) will be assessed with a battery of questionnaires before and after the intervention.

Visits will be scheduled to start between 7:30 AM and 10:30 AM. A research coordinator will provide a detailed description of the study, answer questions, and obtain written informed consent. Participants will complete questionnaires, cognitive tasks, and health assessments (measuring heart rate, weight, blood pressure, and waistline measurements) and have blood drawn. Caregivers, if consented to participate, will fill out self-report questionnaires pertaining to social and emotional well-being. Neural activity using the fMRI will be collected in the Houston Methodist Hospital Translational Imaging Center. After completing the music course, participants will be scheduled for one follow-up visit. The baseline and follow-up visits should last about 2-3 hours at the BRC and about 1.5 hours at Methodist Imaging Center.

Music intervention. Participants in the experimental group will undergo a 6-week music training headed by a musician associated with the Rice's Shepherd School of Music. The music intervention will take place on the main campus of Rice University or at the Bioscience Research Collaborative. The 6-week creative music course designed by Dr. Brandt and the other award-winning composers of Musiqa will be taught by graduate student composers from the Rice Shepherd School of Music. To make the course as accessible as possible, participants will not need to be able to read musical notation or have any prior musical background, and course instructors will utilize established ways of effectively inspiring untrained musicians. J. Todd Frazier, director of the Center for Performing Arts Medicine (CPAM) of Houston Methodist Hospital in the TMC, will aid in planning a concert in the Center's Margaret Alkek Williams Crain Garden Performance Series, at which participants will perform their final compositions for family, caregivers, and members of the community. The chosen curriculum and assessment plan is supported by preliminary work in collaboration with CPAM regarding the benefit of music to neuroplasticity.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Half the participants will be placed in the experimental group while the other half will be placed in the non wait-list control group. 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.Half the participants will be placed in the experimental group while the other half will be placed in the non wait-list control group. 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.

Masking:

None (Open Label)

Masking Description:

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.They are informed which group they have been assigned to at their baseline visit. However, in actuality they are not completely randomized because participants will be recruited in cohorts: all experimental participants will be recruited first, followed by the recruitment of non-waitlist controls. When all experimental participants have been recruited, control participants will be recruited thereafter. Because control participants will not receive the music intervention after the study, the recruitment method will change when controls are recruited for the study. Hence, the non-randomized design of this study.

Primary Purpose:

Supportive Care

Official Title:

Project CHROMA (Cognitive Health Research on Musical Arts)

Actual Study Start Date :

May 29, 2019

Anticipated Primary Completion Date :

Apr 30, 2021

Anticipated Study Completion Date :

Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Music Group 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 A 6-week group music class that incorporates listening, theory, performance, and creation of music.
No Intervention: Non-music group 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.

Arm

Intervention/Treatment

Experimental: Music Group

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

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

No Intervention: Non-music group

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.

Outcome Measures

Primary Outcome Measures

Change from baseline in functional resting state brain activity at follow-up visit. [Functional magnetic resonance imaging will be obtained at enrollment and within one month since the completion of the music course.]
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.
Mean change from baseline in level of creativity using scores on Guilford's alternative Uses Divergent Thinking Test [Creativity will be measured at enrollment and within one month since the completion of the music course.]
Total scores are derived based on fluency, flexibility, originality, and elaboration. Higher scores indicate greater creativity. There is no max score.
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. [Creativity will be measured at enrollment and within one month since the completion of the music course.]
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.
Mean change from baseline in quality of life scores each subscale of the SF-36 [Quality of life will be measured at enrollment and within one month since the completion of the music course.]
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.
Mean change from baseline in inhibition and inhibition/switching trials on the color-word interference test of the Delis Kaplan Executive Function System (DKEFS) [Cognitive scores will be measured at enrollment and within one month since the completion of the music course.]
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.
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). [Cognitive scores will be measured at enrollment and within one month since the completion of the music course.]
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.
Mean change from baseline in perseverative errors on the Wisconsin Card Sorting Test (WCST) [Cognitive scores will be measured at enrollment and within one month since the completion of the music course.]
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.
Mean change from baseline in affect scores on the Positive and Negative Affect Scale [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.]
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.
Mean change from baseline in emotion regulation scores on the Emotional Regulation Scale [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.]
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.

Secondary Outcome Measures

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).]
Serum cytokines and C-reactive protein will be assessed as a biomarker of systemic inflammation. These specific cytokines include: T-cell stimulated IL-6, TNFa, IFNg, IL17a, IL-2. Higher volume (pg/mL) of these individual proinflammatory biomarkers indicates higher levels of inflammation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosed with early to moderate mild cognitive impairment (self-described and confirmed by physician).
Able to read and write in English
Grip strength no lower than 2 standard deviation below the average in their age group

Exclusion Criteria:

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
Diagnosed with comorbid Parkinson's Disease