Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT06866327
Status:
RECRUITING
Last Update Posted:
2025-03-10
First Post:
2025-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Music for the Mind Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D008569', 'term': 'Memory Disorders'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2025-03-04', 'studyFirstSubmitQcDate': '2025-03-04', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Acceptability of the 12-week program they are randomly assigned to', 'timeFrame': 'At enrollment, at the end of the program at 12 weeks', 'description': "The acceptability of the program is evaluated through individual interviews conducted before and after the 12-week program. Both interviews are guided by interview guide developed by the research team. The interviews before the program focus on understanding participants' expectations of the program that they are assigned, while the interviews after the program focus on participants' experiences with the program, its design, and areas for improvement."}, {'measure': 'Satisfaction of the 12-week program they are randomly assigned to', 'timeFrame': 'At the end of the program at 12 weeks', 'description': 'This outcome is measured by a 19-item satisfaction survey developed by the research team. Total scores range from 0 to 80, with higher scores indicating greater satisfaction with the 12-week program to which they are randomly assigned to.'}], 'primaryOutcomes': [{'measure': 'Percent of participants who complete the 12-week program they are randomly assigned to', 'timeFrame': 'From enrollment to the end of the program at 12 weeks', 'description': 'The proportion of participants who complete the program. Feasibility of retention is defined as \\> 80% of enrolled participants in each group complete at least 10 lesson sessions.'}], 'secondaryOutcomes': [{'measure': 'Expectancy of the 12-week program they are randomly assigned to', 'timeFrame': 'At enrollment', 'description': "This outcome is measured by a 6-item self-reported Credibility/ Expectancy Questionnaire (CEQ) that measure participants' views about the expected efficacy of the 12-week program they are randomly assigned to."}, {'measure': 'Percent of participants who are approached and consent to the study', 'timeFrame': 'At enrollment', 'description': 'The proportion of participants are approached and consenting to the study. Feasibility of recruitment is defined as \\> 50% of screened participants consenting to enroll.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['music', 'memory', 'mood', 'emotion', 'well-being'], 'conditions': ['Mild Cognitive Impairment (MCI)', 'Memory Disorders, Age Related', 'Memory Decline']}, 'descriptionModule': {'briefSummary': "The goal of this pilot clinical trial is to learn if older adults with mild cognitive impairment (MCI) find two music programs equally acceptable. This pilot study will help researchers prepare for a future, large-scale clinical trial to learn if music training can slow cognitive decline and promote emotional well-being in those at risk for Alzheimer's disease and related dementias. The main questions this pilot study aims to answer are:\n\n* Do participants like the music programs?\n* Do participants stay enrolled in the study?\n* Do participants report perceived benefits of the programs for their emotional well-being or everyday memory?\n\nParticipants will:\n\n* Participate in 12-weekly sessions of piano lessons or music lessons, with group and individual lessons alternating each week.\n* Have home practice in between lessons, with a keyboard or other instruments provided.\n* Keep a diary of their home practice and their mood before and after practice.\n* Participate in interviews before and after the 12-week programs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 60 years\n* English-speaking\n* Community-dwelling\n* Medical diagnosis of MCI by a physician or research diagnostic criteria for MCI, defined by having Montreal Cognitive Assessment (MoCA), with a cutoff of 20- 25 (further adjusted for racial/ethnic differences)\n* Capable to consent as identified by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)\n* No severe psychiatric condition (e.g., bipolar disorder)\n\nExclusion Criteria:\n\n* Demonstrate musicality knowledge, as assessed by the Musicality Assessment developed by the study team\n* Currently participating in a formal music activity (performance, classes, lessons, etc.)\n* Major impairment in eyesight or hearing that precludes music reading, hearing, or engagement in the class\n* Any difficulty using a keyboard (portable electric piano) due to pain, neuropathy, tremor, or upper finger/hand/limb injury'}, 'identificationModule': {'nctId': 'NCT06866327', 'acronym': 'M4M', 'briefTitle': 'Music for the Mind Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Feasibility and Acceptability of Music Training Programs Among Older Adults Living with Mild Cognitive Impairment: a Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'STUDY00010048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Piano lessons', 'description': 'Introduction to piano playing, including instruction and practice in note reading, finger positions, and song playing.', 'interventionNames': ['Behavioral: Piano lessons']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Music lessons', 'description': 'Introduction to varied instrument playing, music singing, and music appreciation.', 'interventionNames': ['Behavioral: Music Lessons']}], 'interventions': [{'name': 'Piano lessons', 'type': 'BEHAVIORAL', 'description': 'The program consists of 12-weekly piano lessons, alternating small group lessons and individual lessons each week. Individual lessons reinforce and help personalize what is instructed during group lessons. Lessons are tailored to help older adults with memory challenges learn note reading, finger positioning, and song playing. Participants are asked to practice at home in between lessons for 10 minutes per day, 5 times per week, with a keyboard and bench provided.', 'armGroupLabels': ['Piano lessons']}, {'name': 'Music Lessons', 'type': 'BEHAVIORAL', 'description': 'The program consists of 12-weekly music lessons, alternating small group lessons and individual lessons each week. Individual lessons reinforce and help personalize what is instructed during group lessons. Lessons are tailored to help older adults with memory challenges learn various instruments, engage in group playing during group lessons, and engage in music appreciation activities. Participants are asked to practice at home in between lessons for 10 minutes per day, 5 times per week, with instruments provided.', 'armGroupLabels': ['Music lessons']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rose Lin, PhD', 'role': 'CONTACT', 'email': "sinyirose_lin'@urmc.rochester.edu", 'phone': '(585) 276-6833'}], 'facility': 'School of Nursing', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'centralContacts': [{'name': 'Rose Lin, PhD', 'role': 'CONTACT', 'email': 'sinyirose_lin@urmc.rochester.edu', 'phone': '(585) 276-6833'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eastman Performing Arts Medicine Center', 'class': 'UNKNOWN'}, {'name': 'University of Rochester Aging Institute', 'class': 'UNKNOWN'}, {'name': 'University of Rochester School of Nursing', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kathi Heffner', 'investigatorAffiliation': 'University of Rochester'}}}}