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.
4.1 Design A six-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 we will utilize established ways of effactively inspiring untrained musicians (26). It will meet 4 hours per day, for five days a week. The daily music workshops will have four components: listening, theory, performance, and creation (Table 1). Each week will be carefully scaled in difficulty, with the workshops becoming progressively more sophisticated. 4.2 Study Setting The study may take place at different locations depending on assessments. Screening assessments will take place over the phone with a research staff member. Interested individuals will complete the first visit for a baseline blood draw, health assessments, cognitive tasks, and social and emotional well-being assessments at Rice University's BioScience Research Collaborative (BRC) building, Suite 140. Participants will be brought to the BRC building by their caregiver or family member. Baseline neuroimaging will be performed at Houston Methodist Research Institute Translational Imaging Center. Participants will be randomly assigned to either the experimental group (music group) or the control group (non-music group). 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, Rm 707. 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. 4.3 Recruitment and Data Collection Procedures Participant Recruitment: Recruitment. Participants with mild cognitive impairment will be recruited from medical centers, such as Baylor College of Medicine and UT Health. We have partnered with Dr. Jennifer M. Stinson at the Alzheimer's Disease and Memory Disorders Center of BCM, a leading research and clinical center that manages the diagnosis and treatment of more than 3,000 MCI patients a year, along with providing them with avenues for participation in clinical trials. We will establish partnerships with medical facilities that treat mild cognitive impaired patients in order to advertise our study. Specifically, we will obtain IRB approval from outside institutions (e.g., UT Health McGovern Medical School, Baylor St. Luke's, Houston Methodist Hospital, and Baylor College of Medicine) in order to recruit participants directly from medical clinics. Upon approval, physicians may provide us access to their patient clinic schedule, access to patient portal (e.g. EPOCH at Baylor College of Medicine), or the ability to receive patient referrals from the treating physician. Furthermore, this study will be listed on Trial Match, a clinical studies matching service provided by Alzheimer's Association, and on ResearchMatch, a free and secure online tool created by academic institutions across the country. In addition, we will recruit older adult subjects without MCI by proactively posting and distributing flyers at retirement homes, assisted-living homes, community centers, medical facilities, neighborhoods, and community events. These flyers will contain details about our study as well as an email and phone number for further contact. We will also advertise our study on newspapers, social media groups, and/or radio/television. Screening. Participants will be screened over the phone or via online screening form to ensure that they meet general criteria for study participation. If we sense during the phone or online screening that a participant displays cognitive deficits that could not be definitively confirmed, we will send him or her a copy of the consent form. If the participant does not exhibit noticeable cognitive deficits during the phone screening stage, these three questions will be asked when they come in for their first visit, prior to signing the consent form. After the participant reads the consent form, the participant will be asked if they have any questions or need further explanation of what is being asked of them. We will ask three questions to confirm that the participant shows acceptable understanding of his/her participation in the study. These questions seek to verify that the participant understands what involvement in the study entails and his/her ability to refuse participation at any point of the study. If they are able to explain the above, they are considered cognitively competent to participate in the study. For participants with MCI, formal confirmation from the medical doctor is needed to confirm medical diagnosis of mild cognitive impairment. Thus, eligible individuals will be sent an online version or hardcopy version of a medical release form that will be signed and mailed to both us and the doctor. MCI diagnosis is not required for participation but those who claim to have MCI must provide medical documents to confirm this diagnosis. Design and Key Protocol Components: Participants will be instructed to adhere to the regimented breakfast the morning of baseline and follow-up assessment visits. We recognize that this variation may alter internal validity; however, it will maintain external validity (studies have demonstrated that this level of variation has a modest impact on inflammation (27). Participants will also be asked to avoid any strenuous physical activity for 48 hours before the baseline and follow-up assessment visits. All visits will be audio recorded for quality control purposes and surveillance purposes. As mentioned earlier, baseline and follow-up visits will take place at the BRC building on Main street and Houston Methodist Research Institute Translational Imaging Center for both experimental (music group) and control (non-music group) groups. Visits will be scheduled to start between 7:30 AM and 10:30 AM. Participants in the musical group will participate in a 6-week group music course (3 days a week, 2 hours per day) after their baseline visit. Follow-up assessments for the musical group will occur within 2-4 weeks of completion of the 6-week music course. Caregivers will be given the option of mingling with the other caregivers or have relief from care. Participants in the creative reading group (control group) will be asked not to participate in any music-related activities between their baseline and follow-up visits. Baseline and follow-up visits will be scheduled within 3-4 months of each other or mirror the approximate time gap between the baseline visit and follow-up visit for a participant in the music group (experimental group). Those who were not selected for the music course will be given a book with a short survey 1-3 weeks after the follow-up (final) in-person visit. Participant Contact before Baseline and Follow-up Visits: Before the baseline and follow-up assessment visits, a research staff member will call participants (1 day prior) and remind them of the visit. Given that inflammatory markers may be elevated during acute illnesses, such as upper respiratory infections, we will ask them if they are experiencing any illness symptoms (e.g., fever, congestion, sore throat, or acute infections due to injury). During this phone call, we will also ask and ensure they have followed directions not to exercise for 48 hours prior to the visit, to adhere to the regimented breakfast list, and to avoid wearing metal objects. Participants will be rescheduled for a different time if they are ill or did not follow the exercise restriction. Assessments: After the participant reads the consent form, the participant will be asked if they have any questions or need further explanation of what is being asked of them. We will ask three questions to confirm that the participant shows acceptable understanding of participation for eligibility. Study personnel will ensure comprehension by asking what tasks are expected of them with their participation and ask them to explain what they would do if they decided they no longer want to participate in the study. If they are able to adequately answer the above questions, they are considered cognitively competent to participate in the study. Baseline and follow-up assessments will take place on campus at the Bioscience Research Collaborative (BRC) in suite 140 and at the Houston Methodist Research Institute Translational Imaging Center. 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 (e.g., 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 Research Institute 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 3.5-4.5 hours at the BRC and about 1.5 hours at Houston Methodist Research Institute Translational Imaging Center. Financial Compensation: Participants with mild cognitive impairment will be reimbursed at baseline and follow-up visits. For each visit, MCI participants will be compensated $50, for a total of $100 by the end of the study. Completion of the EEfRT task amd Monetary Incentive Delay (MID) task will result in an addition of $5-20 at the baseline visit (based on performance of the task). Participants will be provided with parking validations for each assessment visit and during the 6-week music course.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
81
A 6-week group music class that incorporates listening, theory, performance, and creation of music.
Rice University Bioscience Research Collaborative
Houston, Texas, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Quality of life will be measured at enrollment and within one month since the completion of the music course.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Mean change in inflammation from enrollment (baseline) to follow-up visit
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.
Time frame: Blood will be drawn at enrollment and within one month after the completion of the music study (for experimental group).