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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04137913
Other study ID # IRB-FY2019-355
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 29, 2019
Est. completion date April 30, 2021

Study information

Verified date October 2019
Source William Marsh Rice University
Contact Kristi Parker, M.Ed
Phone 713-348-8224
Email kristi.parker@rice.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Musical arts intervention
A 6-week group music class that incorporates listening, theory, performance, and creation of music.

Locations

Country Name City State
United States Rice University Bioscience Research Collaborative Houston Texas

Sponsors (4)

Lead Sponsor Collaborator
William Marsh Rice University Methodist Research Institute: Center for Performing Arts Medicine, Musiqa, National Endowment for the Arts

Country where clinical trial is conducted

United States, 

References & Publications (120)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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 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. Blood will be drawn at enrollment and within one month after the completion of the music study (for experimental group).
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