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Neurophysiological and Neuroendocrinal Benefits of Music Based Interventions for Early Alzheimer's Patients and Their Caregivers

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• Clinical Dementia Rating 0.5 - 2

• Be a person with or caregiver to a person with a diagnosis of early Alzheimer's Disease, mild dementia, and/or mild cognitive impairment (MCI) and chronic pain defined as non-cancer pain lasting \>3 months that occurs most days and limits life or work activities OR Be a caregiver to a person with a diagnosis of early Alzheimer's Disease, mild dementia, and/or mild cognitive impairment (MCI) and chronic pain defined as non-cancer pain lasting \>3 months that occurs most days and limits life or work activities

• Able to provide informed consent

• Willing to wear an EEG headset and heart rate monitoring devices

• Willing to answer survey questions about topics related to the study

• Willing to be audio / video recorded

• Willing to undergo QST, blood draw, heart rate data collection and cognitive testing

Locations
United States
Connecticut
Connecticut Mental Health Clinic
RECRUITING
New Haven
Contact Information
Primary
AZA Allsop, MD, PhD
Aza.allsop@yale.edu
240-422-3289
Backup
AZA Lab
azalab@yale.edu
203-903-2157
Time Frame
Start Date: 2026-06-09
Estimated Completion Date: 2028-02-01
Participants
Target number of participants: 60
Treatments
Experimental: AD / Dementia / MCI participants with chronic pain and caregivers dyads
Each 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 dyads
Each 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.
Related Therapeutic Areas
Sponsors
Collaborators: National Center for Complementary and Integrative Health (NCCIH), Renée Fleming Foundation, Howard University, NeuroArts Blueprint Initiative
Leads: Yale University

This content was sourced from clinicaltrials.gov