Music for Pain and Dementia (Music4Pain)
Neurophysiological and Neuroendocrinal Benefits of Music Based Interventions for Early Alzheimer's Patients and Their Caregivers
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: AZA Allsop, MD, PhD
- Telefoonnummer: 240-422-3289
- E-mail: Aza.allsop@yale.edu
Studie Contact Back-up
- Naam: AZA Lab
- Telefoonnummer: 203-903-2157
- E-mail: azalab@yale.edu
Studie Locaties
-
-
Connecticut
-
New Haven, Connecticut, Verenigde Staten, 06510
- Werving
- Connecticut Mental Health Clinic
-
Contact:
- Chief Operating Officer
- Telefoonnummer: 203-974-7086
- E-mail: robert.cole@yale.edu
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
A 45-minute to 1-hour group drumming session
|
|
Ander: 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. |
A 45-minute to 1-hour group music-listening session
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in pain phenotyping using a Quantitative Sensory Testing (QST)
Tijdsspanne: Weeks 1 and 10, an average of 9 weeks apart
|
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.
|
Weeks 1 and 10, an average of 9 weeks apart
|
|
Change in pain central sensitization
Tijdsspanne: Weeks 1 and 10, an average of 9 weeks apart
|
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).
|
Weeks 1 and 10, an average of 9 weeks apart
|
|
Change in cortisol levels
Tijdsspanne: Weeks 1 and 10, an average of 9 weeks apart
|
Collecting blood to measure cortisol levels via enzyme-linked immunosorbent assays (ELISA)
|
Weeks 1 and 10, an average of 9 weeks apart
|
|
Change in oxytocin levels
Tijdsspanne: Weeks 1 and 10, an average of 9 weeks apart
|
Collecting blood to measure oxytocin levels via enzyme-linked immunosorbent assays (ELISA)
|
Weeks 1 and 10, an average of 9 weeks apart
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
music information retrieval (MIR) methods
Tijdsspanne: Weeks 2, 3, 4, 5, 6, 7, 8, and 9, an average of 1 week apart
|
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.
|
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
Tijdsspanne: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
|
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.
|
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)
Tijdsspanne: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
|
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.
|
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)
Tijdsspanne: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
|
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.
|
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)
Tijdsspanne: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
|
STAI is a self-report questionnaire that measures transient and enduring levels of anxiety.
20 items on a 5-point Likert scale, from 1 (not at all) to 4 (very much so).
Ten items are formed to record the presence of anxiety symptoms and the other 10 items are scored to record the absence of anxiety symptoms.
Total score is achieved by summing all presence of anxiety items and inverting the absence of anxiety items with total score range from 20-80.
Higher scores indicate higher levels transient and enduring anxiety.
|
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).
Tijdsspanne: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
|
Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure the ratio of low frequency (sympathetic response) and high frequency (parasympathetic response).
This unitless measure is abbreviated as LF/HF and informs the researchers about the relationship between the SNS and PNS.
|
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).
Tijdsspanne: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
|
Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure Very low frequency (VLF) in people with dementia, mild cognitive impairment, and/or Alzheimer's disease.
VLF measure sympathetic responses in milliseconds squared.
|
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).
Tijdsspanne: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
|
Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure the Root Mean Square of Successive Differences (RMSSD) in people with dementia, mild cognitive impairment, and/or Alzheimer's disease.
RMSSD measure parasympathetic responses in milliseconds.
|
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).
Tijdsspanne: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
|
Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure the standard deviation of Normal-to-Normal (SDNN) Interval in people with dementia, mild cognitive impairment, and/or Alzheimer's disease.
SDNN Intervals measure both sympathetic and parasympathetic nervous system (SNS & PNS) responses (primarily sympathetic) in milliseconds.
|
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)
Tijdsspanne: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
|
PHQ-9 is a self-report questionnaire that assesses 8 DSM-IV diagnoses, divided into threshold disorders and subthreshold disorders.
9 items on a 4-point Likert scale, from 0 (not at all) to 3 (nearly everyday).
An item was also added to the end of the diagnostic portion of the PHQ-9 asking patients who checked off any problems on the questionnaire how difficult these symptoms make the respondent's life.
Total score is achieved by summing all items with total score range from 0-27.
Higher scores indicate higher depression severity.
|
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)
Tijdsspanne: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
|
ZBI is a self-report questionnaire that measures the level of burden experienced by caregivers of patients with dementia.
22 items on a 5-point Likert scale, from 0 (never) to 4 (nearly always).
Total score is achieved by summing all items with total score range from 0-88.
Higher scores indicate greater burden.
|
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)
Tijdsspanne: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
|
QOLS is a self-report questionnaire that measures 5 conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation.
16 items on a 7-point Likert scale, from 1 (terrible) to 7 (delighted).
Total score is achieved by summing all items with total score range from 16-112.
Higher scores indicate a greater satisfaction with life.
|
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
|
|
Change in EEG (brain) activity pre vs post intervention and between experimental and control groups
Tijdsspanne: Weeks 1 and 10, an average of 9 weeks apart
|
EEG gamma measured by the Post Spectral Density measures in the gamma range (>30Hz) and theta (4-8Hz) frequency ranges pre and post drumming intervention
|
Weeks 1 and 10, an average of 9 weeks apart
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: AZA Allsop, MD, PhD, Yale University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2000038702_a
- U24AT012601 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .