Music for Pain and Dementia
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- Yale University
- Study ID
- NCT07602283
- Status
- Recruiting
Conditions
- Alzheimer Disease
- Caregiver
- Dementia
- Mild Cognitive Impairment
- Peer-bonded Caregiver
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Drumming session — BEHAVIORALA 45-minute to 1-hour group drumming session
- Music-listening session — BEHAVIORALA 45-minute to 1-hour group music-listening session
Study Details
This study aims to provide mechanistic insights into how group drumming as a music-based intervention (MBI) affects pain responses and nociceptive function in individuals with Alzheimer's Disease (AD), mild dementia or mild cognitive impairment (MCI). Heart rate (HR), heart rate variability (HRV), and brain activity will be measured during communal drumming with their dyadic partners and others. Brain activity, blood pressure, cognitive abilities, blood hormone levels, and static and dynamic pain will also be measured during sessions pre and post the 8-week community drum circle. Investigators will leverage various measurement techniques including, but not limited to, electroencephalography (EEG), quantitative sensory testing (QST), behavioral, surveys, and physiological monitoring to study the impact of group drumming on pain and brain activity in AD and inter-dyad synchrony.
Key Dates
- Start date
- Jun 1, 2026
- Status verified
- May 2026
- Primary completion
- Aug 1, 2027
- Completion
- Feb 1, 2028
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: AD / Dementia / MCI participants with chronic pain and caregivers dyadsEach participant pair will take part in ten weekly sessions. All sessions will last up to 3 hours. During Week 1, participants will have physiological, bloodwork, communication/language, pain sensitivity, and survey data collected to assess baseline levels of brain activity, heart rate, blood hormones, cognition, dynamic pain, and psychological symptoms. In Weeks 2 through 9, participants will participate in a 45-minute to 1-hour drumming session during which investigators will collect heart data. Psychometric survey data will be collected before and after each session. During Week 10, participants will have physiological, bloodwork, communication/language, pain sensitivity, and survey data collected to assess post-intervention levels of brain activity, heart rate, blood hormones, cognition, dynamic pain, and psychological symptoms.
- Other: AD / Dementia / MCI participants without chronic pain and caregivers dyadsEach participant pair will take part in ten weekly sessions. All sessions will last up to 3 hours. During Week 1, participants will have physiological, bloodwork, communication/language, pain sensitivity, and survey data collected to assess baseline levels of brain activity, heart rate, blood hormones, cognition, dynamic pain, and psychological symptoms. In Weeks 2 through 9, participants will participate in a 45-minute to 1-hour music-listening session during which investigators will collect heart data. Psychometric survey data will be collected before and after each session. During Week 10, participants will have physiological, bloodwork, communication/language, pain sensitivity, and survey data collected to assess post-intervention levels of brain activity, heart rate, blood hormones, cognition, dynamic pain, and psychological symptoms.
Primary Outcome Measure
Change in pain phenotyping using a Quantitative Sensory Testing (QST) [ Time Frame: Weeks 1 and 10, an average of 9 weeks apart ]
Central Contacts
- AZA Allsop, MD, PhD240-422-3289
- AZA Lab203-903-2157
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Connecticut Mental Health Clinic | New Haven | Connecticut | 06510 |
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