Music for Pain and Dementia: Group Drumming for people with early dementia and their caregivers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates how a group drumming program, compared with music listening, affects pain responses and nociceptive function in individuals with mild dementia or MCI and in their dyadic caregivers. Researchers will measure heart rate, heart rate variability, brain activity, blood pressure, hormones, and pain responses during an 8-week program, using EEG, quantitative sensory testing, surveys, and physiological monitoring. Analyses will explore brain–body synchrony between participants and caregivers, potential neurophysiological changes, and hormone fluctuations that may relate to pain modulation. The study uses recordings from drum circles and applies music information retrieval and related techniques to understand mechanisms by which communal drumming could influence pain and social connection.

Why it matters

Who can join: the full rules

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

Where it's running

• Connecticut Mental Health Clinic
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: AZA Allsop, MD, PhD — Yale University
• Study coordinator: AZA Allsop, MD, PhD
• Email: Aza.allsop@yale.edu
• Phone: 240-422-3289

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.