Music for Pain and Dementia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Drumming session, Music-listening session.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease, Dementia, Mild Cognitive Impairment, Peer-bonded Caregiver. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neurophysiological and Neuroendocrinal Benefits of Music Based Interventions for Early Alzheimer's Patients and Their Caregivers
Overview
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.
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.
Interventions
- Behavioral Drumming session
A 45-minute to 1-hour group drumming session - Behavioral Music-listening session
A 45-minute to 1-hour group music-listening session
Primary outcome measures
- 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]
Secondary outcome measures (12)
- music information retrieval (MIR) methods [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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). [Time frame: 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). [Time frame: 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). [Time frame: 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). [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Connecticut Mental Health Clinic — New Haven
Identifiers
NCT: NCT07602283 · 2000038702_a · U24AT012601