Cognitive Health Research on Musical Arts — CHROMA  

Cognitive Impairment Clinical Trial

Official title: Project CHROMA (Cognitive Health Research on Musical Arts)

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Creativity

• NCT number: NCT04137913
• Study type: Interventional
• Source: William Marsh Rice University
• Contact: Kristi Parker, M.Ed
• Phone: 713-348-8224
• Email: kristi.parker@rice.edu
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2019
• Completion date: April 30, 2021