Cognitive ImpairmentCHROMANCT04137913
Cognitive Health Research on Musical Arts
A study testing Musical arts intervention in people with Cognitive Impairment and Creativity, run by William Marsh Rice University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Creativity
- What is being tested?
- Musical arts intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2019to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rice University Bioscience Research Collaborative
Houston, Texas, 77030
About this study
Official title: Project CHROMA (Cognitive Health Research on Musical Arts)
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.
Read the detailed description
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.
- Conditions
- Cognitive Impairment, Creativity
- Being tested
- Musical arts intervention
- Keywords
- mild cognitive impairment, musical arts, whole brain network, cognition, aging
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musical arts interventionBehavioural
A 6-week group music class that incorporates listening, theory, performance, and creation of music.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Blood will be drawn at enrollment and within one month after the completion of the music study (for experimental group).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start19 Nov 2019
- Primary completion10 Nov 2022
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (121)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 (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.
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Marsh Rice University
- Sponsor type
- University, hospital or other
- Collaborators
- National Endowment for the Arts, United States, The Methodist Hospital Research Institute
- Responsible party
- Sponsor
- Investigators
- Christopher P Fagundes, Ph.D., Principal investigator, William Marsh Rice University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137913
- Sponsor's protocol ID
- IRB-FY2019-355
- Acronym
- CHROMA
- Status last verified
- Feb 2025
- First submitted
- 8 Oct 2019
- Last updated
- 25 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karmonik C, Brandt A, Anderson J, Brooks F, Lytle J, Silverman E, Frazier JT. Music Listening modulates Functional Connectivity and Information Flow in the Human Brain. Brain Connect. 2016 Oct;6(8):632-641. doi: 10.1089/brain.2016.0428. Epub 2016 Jul 27.
PubMed 27464741Yue Q, Martin RC, Fischer-Baum S, Ramos-Nunez AI, Ye F, Deem MW. Brain Modularity Mediates the Relation between Task Complexity and Performance. J Cogn Neurosci. 2017 Sep;29(9):1532-1546. doi: 10.1162/jocn_a_01142. Epub 2017 May 4.
PubMed 28471728Jaremka LM, Andridge RR, Fagundes CP, Alfano CM, Povoski SP, Lipari AM, Agnese DM, Arnold MW, Farrar WB, Yee LD, Carson WE 3rd, Bekaii-Saab T, Martin EW Jr, Schmidt CR, Kiecolt-Glaser JK. Pain, depression, and fatigue: loneliness as a longitudinal risk factor. Health Psychol. 2014 Sep;33(9):948-57. doi: 10.1037/a0034012. Epub 2013 Aug 19.
PubMed 23957903Brandt A, Gebrian M, Slevc LR. Music and early language acquisition. Front Psychol. 2012 Sep 11;3:327. doi: 10.3389/fpsyg.2012.00327. eCollection 2012.
PubMed 22973254Parbery-Clark A, Skoe E, Lam C, Kraus N. Musician enhancement for speech-in-noise. Ear Hear. 2009 Dec;30(6):653-61. doi: 10.1097/AUD.0b013e3181b412e9.
PubMed 19734788Kraus N, Slater J, Thompson EC, Hornickel J, Strait DL, Nicol T, White-Schwoch T. Music enrichment programs improve the neural encoding of speech in at-risk children. J Neurosci. 2014 Sep 3;34(36):11913-8. doi: 10.1523/JNEUROSCI.1881-14.2014.
PubMed 25186739Bengtsson SL, Csikszentmihalyi M, Ullen F. Cortical regions involved in the generation of musical structures during improvisation in pianists. J Cogn Neurosci. 2007 May;19(5):830-42. doi: 10.1162/jocn.2007.19.5.830.
PubMed 17488207Limb CJ, Braun AR. Neural substrates of spontaneous musical performance: an FMRI study of jazz improvisation. PLoS One. 2008 Feb 27;3(2):e1679. doi: 10.1371/journal.pone.0001679.
PubMed 18301756He J, Sun J, Deem MW. Spontaneous emergence of modularity in a model of evolving individuals and in real networks. Phys Rev E Stat Nonlin Soft Matter Phys. 2009 Mar;79(3 Pt 1):031907. doi: 10.1103/PhysRevE.79.031907. Epub 2009 Mar 17.
PubMed 19391971Park JM, Niestemski LR, Deem MW. Quasispecies theory for evolution of modularity. Phys Rev E Stat Nonlin Soft Matter Phys. 2015 Jan;91(1):012714. doi: 10.1103/PhysRevE.91.012714. Epub 2015 Jan 28.
PubMed 25679649Holmen K, Ericsson K, Winblad B. Social and emotional loneliness among non-demented and demented elderly people. Arch Gerontol Geriatr. 2000 Dec;31(3):177-192. doi: 10.1016/s0167-4943(00)00070-4.
PubMed 11154772Steptoe A, Shankar A, Demakakos P, Wardle J. Social isolation, loneliness, and all-cause mortality in older men and women. Proc Natl Acad Sci U S A. 2013 Apr 9;110(15):5797-801. doi: 10.1073/pnas.1219686110. Epub 2013 Mar 25.
PubMed 23530191Stuckey HL, Nobel J. The connection between art, healing, and public health: a review of current literature. Am J Public Health. 2010 Feb;100(2):254-63. doi: 10.2105/AJPH.2008.156497. Epub 2009 Dec 17.
PubMed 20019311Jaremka LM, Fagundes CP, Glaser R, Bennett JM, Malarkey WB, Kiecolt-Glaser JK. Loneliness predicts pain, depression, and fatigue: understanding the role of immune dysregulation. Psychoneuroendocrinology. 2013 Aug;38(8):1310-7. doi: 10.1016/j.psyneuen.2012.11.016. Epub 2012 Dec 27.
PubMed 23273678Chen M, Deem MW. Development of modularity in the neural activity of children's brains. Phys Biol. 2015 Jan 26;12(1):016009. doi: 10.1088/1478-3975/12/1/016009.
PubMed 25619207
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project CHROMA (Cognitive Health Research on Musical Arts)
- ClinicalTrials.gov ID
- NCT04137913
- Acronym / sponsor ID
- CHROMA / IRB-FY2019-355
- Conditions
- Cognitive Impairment, Creativity
- Keywords
- mild cognitive impairment, musical arts, whole brain network, cognition, aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- William Marsh Rice UniversityUniversity, hospital or other
- Collaborators
- National Endowment for the Arts, United States, The Methodist Hospital Research Institute
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 (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.
| Arm | Type | Receives |
|---|---|---|
| Music Group | Experimental | Behavioral: Musical arts interventionIndividuals 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. |
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musical arts interventionA 6-week group music class that incorporates listening, theory, performance, and creation of music. | Behavioural | Music Group |
Primary outcome
Change from baseline in functional resting state brain activity at follow-up visit.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: 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
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.
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
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.
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.
1 secondary outcome
Mean change in inflammation from enrollment (baseline) to follow-up visit
Time frame: Blood will be drawn at enrollment and within one month after the completion of the music study (for experimental group).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 27464741Karmonik C, Brandt A, Anderson J, Brooks F, Lytle J, Silverman E, Frazier JT. Music Listening modulates Functional Connectivity and Information Flow in the Human Brain. Brain Connect. 2016 Oct;6(8):632-641. doi: 10.1089/brain.2016.0428. Epub 2016 Jul 27.
- Background: PubMed 28471728Yue Q, Martin RC, Fischer-Baum S, Ramos-Nunez AI, Ye F, Deem MW. Brain Modularity Mediates the Relation between Task Complexity and Performance. J Cogn Neurosci. 2017 Sep;29(9):1532-1546. doi: 10.1162/jocn_a_01142. Epub 2017 May 4.
- Background: PubMed 23957903Jaremka LM, Andridge RR, Fagundes CP, Alfano CM, Povoski SP, Lipari AM, Agnese DM, Arnold MW, Farrar WB, Yee LD, Carson WE 3rd, Bekaii-Saab T, Martin EW Jr, Schmidt CR, Kiecolt-Glaser JK. Pain, depression, and fatigue: loneliness as a longitudinal risk factor. Health Psychol. 2014 Sep;33(9):948-57. doi: 10.1037/a0034012. Epub 2013 Aug 19.
- Background: PubMed 22973254Brandt A, Gebrian M, Slevc LR. Music and early language acquisition. Front Psychol. 2012 Sep 11;3:327. doi: 10.3389/fpsyg.2012.00327. eCollection 2012.
- Background: PubMed 19734788Parbery-Clark A, Skoe E, Lam C, Kraus N. Musician enhancement for speech-in-noise. Ear Hear. 2009 Dec;30(6):653-61. doi: 10.1097/AUD.0b013e3181b412e9.
- Background: PubMed 25186739Kraus N, Slater J, Thompson EC, Hornickel J, Strait DL, Nicol T, White-Schwoch T. Music enrichment programs improve the neural encoding of speech in at-risk children. J Neurosci. 2014 Sep 3;34(36):11913-8. doi: 10.1523/JNEUROSCI.1881-14.2014.
- Background: PubMed 17488207Bengtsson SL, Csikszentmihalyi M, Ullen F. Cortical regions involved in the generation of musical structures during improvisation in pianists. J Cogn Neurosci. 2007 May;19(5):830-42. doi: 10.1162/jocn.2007.19.5.830.
- Background: PubMed 18301756Limb CJ, Braun AR. Neural substrates of spontaneous musical performance: an FMRI study of jazz improvisation. PLoS One. 2008 Feb 27;3(2):e1679. doi: 10.1371/journal.pone.0001679.
- Background: PubMed 19391971He J, Sun J, Deem MW. Spontaneous emergence of modularity in a model of evolving individuals and in real networks. Phys Rev E Stat Nonlin Soft Matter Phys. 2009 Mar;79(3 Pt 1):031907. doi: 10.1103/PhysRevE.79.031907. Epub 2009 Mar 17.
- Background: PubMed 25679649Park JM, Niestemski LR, Deem MW. Quasispecies theory for evolution of modularity. Phys Rev E Stat Nonlin Soft Matter Phys. 2015 Jan;91(1):012714. doi: 10.1103/PhysRevE.91.012714. Epub 2015 Jan 28.
- Background: PubMed 11154772Holmen K, Ericsson K, Winblad B. Social and emotional loneliness among non-demented and demented elderly people. Arch Gerontol Geriatr. 2000 Dec;31(3):177-192. doi: 10.1016/s0167-4943(00)00070-4.
- Background: PubMed 23530191Steptoe A, Shankar A, Demakakos P, Wardle J. Social isolation, loneliness, and all-cause mortality in older men and women. Proc Natl Acad Sci U S A. 2013 Apr 9;110(15):5797-801. doi: 10.1073/pnas.1219686110. Epub 2013 Mar 25.
- The Rice Arts, Cognition, and Health Science Initiative website.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cognitive Impairment
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher P Fagundes, Ph.D. principal investigator
William Marsh Rice University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Musical arts intervention in people with Cognitive Impairment and Creativity, run by William Marsh Rice University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in functional resting state brain activity at follow-up visit. (time frame: Functional magnetic resonance imaging will be obtained at enrollment and within one month since the completion of the music course.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04137913, which also lists 121 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.