60 Participants NeededMy employer runs this trial

Music for Alzheimer's and Dementia

(Music4Pain Trial)

AA
AL
Overseen ByAZA Lab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AA

AZA Allsop, MD, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for people with early Alzheimer's, mild dementia, or mild cognitive impairment who have ongoing non-cancer pain lasting over 3 months and affects daily life. Caregivers of such individuals can also join. Participants must be able to consent and willing to take part in various tests and recordings.

Inclusion Criteria

* Able to provide informed consent
* Clinical Dementia Rating 0.5 - 2
* Willing to wear an EEG headset and heart rate monitoring devices
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo deep phenotyping of pain using QST, blood sampling, brain activity recordings, and psychometric assessments

1 week
1 visit (in-person)

Intervention

Participants engage in weekly drumming sessions or music-listening activities, with heart data and psychometric surveys collected

8 weeks
8 visits (in-person)

Post-Intervention Assessment

Participants undergo post-intervention assessments including physiological, bloodwork, communication/language, pain sensitivity, and survey data collection

1 week
1 visit (in-person)

Follow-up

Participants are monitored for changes in pain perception, brain activity, and psychological symptoms

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Group Drumming
  • Music-listening session

Trial Overview

The study compares group drumming sessions with music-listening sessions to see how they affect pain levels, brain activity, heart rate, and mood in people with memory problems or their caregivers over an 8-week period.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: AD / Dementia / MCI participants without chronic pain and caregivers dyadsExperimental Treatment1 Intervention
Group II: AD / Dementia / MCI participants with chronic pain and caregivers dyadsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

NeuroArts Blueprint Initiative

Collaborator

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

Renée Fleming Foundation

Collaborator

Yale University School of Medicine, Department of Psychiatry

Collaborator

Howard University

Collaborator

Trials
44
Recruited
15,200+