Music for Pain and Dementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorYale University
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Drumming session
BehavioralA 45-minute to 1-hour group drumming session
Music-listening session
BehavioralA 45-minute to 1-hour group music-listening session
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: AD / Dementia / MCI participants with chronic pain and caregivers dyadsExperimental treatment 1 intervention
Group B: AD / Dementia / MCI participants without chronic pain and caregivers dyadsOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Weeks 1 and 10, an average of 9 weeks apart2
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).
Time frame
Weeks 1 and 10, an average of 9 weeks apart3
Change in cortisol levels
Collecting blood to measure cortisol levels via enzyme-linked immunosorbent assays (ELISA)
Time frame
Weeks 1 and 10, an average of 9 weeks apart4
Change in oxytocin levels
Collecting blood to measure oxytocin levels via enzyme-linked immunosorbent assays (ELISA)
Time frame
Weeks 1 and 10, an average of 9 weeks apartSecondary outcomes
1
music information retrieval (MIR) methods
Analyzing the physical characteristics of the drumming played during the sessions via music information retrieval (MIR) methods help the researchers make inferences about what musical parameters modulate wellbeing, connectedness, and behavior in this population.
Time frame
Weeks 2, 3, 4, 5, 6, 7, 8, and 9, an average of 1 week apart2
Change in social connection using State Motivation to Foster Social Connections (SMFSCS)Scale
SMFSCS is a self-report questionnaire that measures the motivation individuals feel to form new connections and foster existing connection with others. 10 items on a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Total score is achieved by summing all items with total score range from 10-100. Higher scores indicate a greater motivation to create new connections and foster existing connections with others.
Time frame
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart3
Change in absorption in music using the Absorption in Music Scale (AIMS)
SMFSCS is a self-report questionnaire that measures an individual's tendency to have strong emotional responses to music. 35 items on a 5-point Likert scale, from 1 (strongly disagree) to 5 (strongly agree). Total score is achieved by summing all items with total score range from 35-175. Higher scores indicate a greater tendency to have strong emotional responses to music.
Time frame
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart4
Change in absorption in music using the Geriatric Anxiety Scale (GAS)
GAS is a self-report questionnaire that serves as a measure of anxiety for use with older adults. 30 items on a 5-point Likert scale, from 0 (not at all) to 3 (all of the time). Total score is achieved by summing items 1-25 with total score range from 0-75. Items 26 through 30 are used to help clinicians identify areas of concern for the respondent. Higher scores indicate more feelings of anxiety or stress.
Time frame
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apartSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Renée Fleming Foundation
Collaborator
Howard University
Collaborator
NeuroArts Blueprint Initiative
Collaborator
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov