Music for Pain and Dementia

NCT07602283 | Recruiting

• 2 other identifiers: 2000038702_aU24AT012601
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease; Dementia; Mild Cognitive Impairment; Peer-bonded Caregiver; Caregiver

Keywords

Live Music; EEG; EKG/ECG; Anxiety; Connectedness; Social Connection

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (13)

• music information retrieval (MIR) methods

  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

  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)

  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)

  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)

  Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart

Study Arms (2)

AD / Dementia / MCI participants with chronic pain and caregivers dyads

EXPERIMENTAL

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

AD / Dementia / MCI participants without chronic pain and caregivers dyads

OTHER

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

Interventions

Drumming session BEHAVIORAL

A 45-minute to 1-hour group drumming session

AD / Dementia / MCI participants with chronic pain and caregivers dyads

Music-listening session BEHAVIORAL

A 45-minute to 1-hour group music-listening session

AD / Dementia / MCI participants without chronic pain and caregivers dyads

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Renée Fleming Foundation: collaborator
• Yale University School of Medicine, Department of Psychiatry: collaborator
• Howard University: collaborator
• NeuroArts Blueprint Initiative: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Connecticut Mental Health Clinic

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction; Anxiety Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• AZA Allsop, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AZA Allsop, MD, PhD

CONTACT

240-422-3289; Aza.allsop@yale.edu

AZA Lab

CONTACT

203-903-2157; azalab@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigators aim to enroll into the experimental group early Alzheimer's (AD) / Dementia / Mild Cognitive Impairment (MCI) participants, who have non-cancerous chronic pain lasting at least 3 months, and their caregivers. Investigators aim to enroll into the control group early Alzheimer's (AD) / Dementia / Mild Cognitive Impairment (MCI) participants, who do not have non-cancerous chronic pain lasting at least 3 months, and their caregivers. A target sample size of 60 participants is proposed with an upper limit of 120 participants enrolled to allow for the possibility of losing a portion of the sample to follow-up.

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)