Music for Pain and Dementia (Music4Pain)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dementia; Alzheimer Disease; Mild Cognitive Impairment; Caregiver; Peer-bonded Caregiver
• Intervention / Treatment: Behavioral: Drumming session; Behavioral: Music-listening session

Detailed Description

Analysis of recordings captured during drum circles will be conducted using music information retrieval, pulse clarity, psychological ethnography, and similar methods. Investigators hypothesize that (1) the communal drum circles will lead to a decrease in dynamic pain (e.g. sensitivity to repeated stimuli), (2) the ability of the brain to change and adapt will be enhanced in the drumming group compared to the control group, (3) change in and synchrony of heart rate between participants might underlie the impact of communal drumming on pain, and (4) group drumming will increase circulating oxytocin and serotonin and that the modulation of these neurohormones contribute to decreased pain phenomenon.

The primary objective of this study is to investigate how group drumming affects pain responses and nociceptive function in individuals with mild dementia or mild cognitive impairment.

The secondary objectives of this study are to:

• Use quantitative sensory testing (QST) and blood sampling to investigate potential effects of communal drumming on static and dynamic pain and endocrine hormone variability in individuals with dementia.
• Understand neurophysiological changes (i.e. changes in EEG assessments) that may underlie the effects of an 8-week drum circle on pain, endocrinology, and variations in neurobiology in those living with dementia.
• Analyze phase synchrony between dementia participants and their caregivers before and after the intervention to assess shifts in brain synchrony dynamics.
• Analyze heart rate and heart rate variability parameters during group drumming and characterize changes in autonomic nervous system activity within and across group drum sessions.
• Analyze audio recording data to identify behavioral and auditory synchrony dynamics throughout the communal drumming intervention.

In-person sessions of the study will be conducted by Yale IRB-approved study team members at the Connecticut Mental Health Center (CMHC; 34 Park St, New Haven, CT 06519).

Each participant pair, consisting of one person with dementia and chronic pain (or without chronic pain in the control group) and their caregiver/study partner will take part in ten weekly sessions.

During Week 1, participants will arrive to the CMHC to undergo deep phenotyping of pain using QST, blood sampling, brain activity recordings will be performed for baseline and plasticity analysis, and participants will fill out psychometric assessments (~3 hours). Participants will also be asked to complete communication/language assessments.

During Weeks 2 through 9, participants in the experimental group will be asked to arrive to the CMHC to participate in 45-minute to 1-hour drumming sessions. Participants in the control group will participate in a listening activity. All participants with be asked to complete psychometric assessments before and after the drumming sessions.

During Week 10, participants will return to the CMHC for deep phenotyping of pain, bloodwork, EEG data collection, and psychometric surveys, and communication/language assessments.

Collection of these data allow investigators to assess the impact of communal drumming on brain activity, heart rate, pain perception, psychological symptoms, blood hormone levels, and communication/language.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: AZA Allsop, MD, PhD; Phone Number: 240-422-3289; Email: Aza.allsop@yale.edu
• Study Contact Backup: Name: AZA Lab; Phone Number: 203-903-2157; Email: azalab@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Connecticut Mental Health Clinic
      • Contact: Chief Operating Officer; Phone Number: 203-974-7086; Email: robert.cole@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Clinical Dementia Rating <0.5 or > 2
• Unable to provide informed consent
• Endorsing suicidal ideation (SI), self-injurious behavior, or homicidal ideation (HI) above the threshold defined in the "Risk Reduction and Safety Plan"
• Participating in another clinical trial studying AD and/or Dementia
• Starting a new prescription medication in the last 4 weeks
• Taking central nervous system acting medications that may interfere with study measurements as determined at PI discretion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Drumming session; A 45-minute to 1-hour group drumming session
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.	Behavioral: Music-listening session; A 45-minute to 1-hour group music-listening session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain phenotyping using a Quantitative Sensory Testing (QST)	Pain phenotyping before and after the intervention using a Quantitative Sensory Testing (QST). QST will be used to measure pain threshold (the point at which pain is first felt) and pain tolerance (the point at which the participant discontinues the test due to pain). The battery includes several nociceptive modalities such as pressure, mechanical, heat, and cold stimuli. The main outcome will be a composite pain sensitivity measure, integrating data from the QST battery.	Weeks 1 and 10, an average of 9 weeks apart
Change in pain central sensitization	Quanititative sensory testing (QST) will be used to assess central sensitization before and after an 8-week drum circle intervention. A central sensitization score will be generated by averaging mechanical temporal summation (TSP), thermal TSP, and conditioned pain modulation (CPM). Negative values will denote antinociception, and positive values will denote pronociception (or central sensitization).	Weeks 1 and 10, an average of 9 weeks apart
Change in cortisol levels	Collecting blood to measure cortisol levels via enzyme-linked immunosorbent assays (ELISA)	Weeks 1 and 10, an average of 9 weeks apart
Change in oxytocin levels	Collecting blood to measure oxytocin levels via enzyme-linked immunosorbent assays (ELISA)	Weeks 1 and 10, an average of 9 weeks apart

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
music information retrieval (MIR) methods	Analyzing the physical characteristics of the drumming played during the sessions via music information retrieval (MIR) methods help the researchers make inferences about what musical parameters modulate wellbeing, connectedness, and behavior in this population.	Weeks 2, 3, 4, 5, 6, 7, 8, and 9, an average of 1 week apart
Change in social connection using State Motivation to Foster Social Connections (SMFSCS)Scale	SMFSCS is a self-report questionnaire that measures the motivation individuals feel to form new connections and foster existing connection with others. 10 items on a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Total score is achieved by summing all items with total score range from 10-100. Higher scores indicate a greater motivation to create new connections and foster existing connections with others.	Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Change in absorption in music using the Absorption in Music Scale (AIMS)	SMFSCS is a self-report questionnaire that measures an individual's tendency to have strong emotional responses to music. 35 items on a 5-point Likert scale, from 1 (strongly disagree) to 5 (strongly agree). Total score is achieved by summing all items with total score range from 35-175. Higher scores indicate a greater tendency to have strong emotional responses to music.	Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Change in absorption in music using the Geriatric Anxiety Scale (GAS)	GAS is a self-report questionnaire that serves as a measure of anxiety for use with older adults. 30 items on a 5-point Likert scale, from 0 (not at all) to 3 (all of the time). Total score is achieved by summing items 1-25 with total score range from 0-75. Items 26 through 30 are used to help clinicians identify areas of concern for the respondent. Higher scores indicate more feelings of anxiety or stress.	Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Change in absorption in music using the State-Trait Anxiety Inventory (STAI)	STAI is a self-report questionnaire that measures transient and enduring levels of anxiety. 20 items on a 5-point Likert scale, from 1 (not at all) to 4 (very much so). Ten items are formed to record the presence of anxiety symptoms and the other 10 items are scored to record the absence of anxiety symptoms. Total score is achieved by summing all presence of anxiety items and inverting the absence of anxiety items with total score range from 20-80. Higher scores indicate higher levels transient and enduring anxiety.	Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Changes in the ratio of low frequency and high frequency (LF/HF) via electrocardiography (ECG, EKG).	Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure the ratio of low frequency (sympathetic response) and high frequency (parasympathetic response). This unitless measure is abbreviated as LF/HF and informs the researchers about the relationship between the SNS and PNS.	Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Changes in Very low frequency (VLF) via electrocardiography (ECG, EKG).	Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure Very low frequency (VLF) in people with dementia, mild cognitive impairment, and/or Alzheimer's disease. VLF measure sympathetic responses in milliseconds squared.	Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Changes in Root Mean Square of Successive Differences (RMSSD) via electrocardiography (ECG, EKG).	Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure the Root Mean Square of Successive Differences (RMSSD) in people with dementia, mild cognitive impairment, and/or Alzheimer's disease. RMSSD measure parasympathetic responses in milliseconds.	Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Changes in Standard Deviation of Normal-to-Normal (SDNN) Interval via electrocardiography (ECG, EKG).	Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure the standard deviation of Normal-to-Normal (SDNN) Interval in people with dementia, mild cognitive impairment, and/or Alzheimer's disease. SDNN Intervals measure both sympathetic and parasympathetic nervous system (SNS & PNS) responses (primarily sympathetic) in milliseconds.	Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Change in absorption in music using the Patient Health Questionnaire-9 (PHQ-9)	PHQ-9 is a self-report questionnaire that assesses 8 DSM-IV diagnoses, divided into threshold disorders and subthreshold disorders. 9 items on a 4-point Likert scale, from 0 (not at all) to 3 (nearly everyday). An item was also added to the end of the diagnostic portion of the PHQ-9 asking patients who checked off any problems on the questionnaire how difficult these symptoms make the respondent's life. Total score is achieved by summing all items with total score range from 0-27. Higher scores indicate higher depression severity.	Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Change in absorption in music using the Zarit Burden Interview (ZBI)	ZBI is a self-report questionnaire that measures the level of burden experienced by caregivers of patients with dementia. 22 items on a 5-point Likert scale, from 0 (never) to 4 (nearly always). Total score is achieved by summing all items with total score range from 0-88. Higher scores indicate greater burden.	Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Change in absorption in music using the Quality of Life Scale (QOLS)	QOLS is a self-report questionnaire that measures 5 conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation. 16 items on a 7-point Likert scale, from 1 (terrible) to 7 (delighted). Total score is achieved by summing all items with total score range from 16-112. Higher scores indicate a greater satisfaction with life.	Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Change in EEG (brain) activity pre vs post intervention and between experimental and control groups	EEG gamma measured by the Post Spectral Density measures in the gamma range (>30Hz) and theta (4-8Hz) frequency ranges pre and post drumming intervention	Weeks 1 and 10, an average of 9 weeks apart

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); Howard University; Renée Fleming Foundation; Yale University School of Medicine, Department of Psychiatry; NeuroArts Blueprint Initiative
• Investigators: Principal Investigator: AZA Allsop, MD, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: May 15, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Anxiety; EEG; Connectedness; Social Connection; Live Music; EKG/ECG
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases; Anxiety Disorders; Cognitive Dysfunction; Alzheimer Disease; Dementia
• Other Study ID Numbers: 2000038702_a; U24AT012601 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No