Recruiting

Group Drumming

Sponsor:

Yale University

Code:

NCT07602283

Conditions

Alzheimer Disease

Dementia

Mild Cognitive Impairment

Peer-bonded Caregiver

Caregiver

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Drumming session

Music-listening session

Study Details

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

Study ID

NCT07602283

Start date

Jun 9, 2026

Status verified date

Jun, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

Drumming session

A 45-minute to 1-hour group drumming session

Music-listening session

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

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 ]
  • Change in pain central sensitization [ Time Frame: Weeks 1 and 10, an average of 9 weeks apart ]
  • Change in cortisol levels [ Time Frame: Weeks 1 and 10, an average of 9 weeks apart ]
  • Change in oxytocin levels [ Time Frame: Weeks 1 and 10, an average of 9 weeks apart ]

Central Contacts and Locations

Central contacts

AZA Allsop, MD, PhD

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

AZA Lab

203-903-2157azalab@yale.edu

Locations

Connecticut Mental Health Clinic

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Chief Operating Officer

203-974-7086robert.cole@yale.edu

More Information

Sponsor

Yale University

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-12.