Music for Pain and Dementia (Music4Pain)
Neurophysiological and Neuroendocrinal Benefits of Music Based Interventions for Early Alzheimer's Patients and Their Caregivers
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: AZA Allsop, MD, PhD
- 전화번호: 240-422-3289
- 이메일: Aza.allsop@yale.edu
연구 연락처 백업
- 이름: AZA Lab
- 전화번호: 203-903-2157
- 이메일: azalab@yale.edu
연구 장소
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Connecticut
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New Haven, Connecticut, 미국, 06510
- 모병
- Connecticut Mental Health Clinic
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연락하다:
- Chief Operating Officer
- 전화번호: 203-974-7086
- 이메일: robert.cole@yale.edu
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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
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다른: 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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in pain phenotyping using a Quantitative Sensory Testing (QST)
기간: Weeks 1 and 10, an average of 9 weeks apart
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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.
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Weeks 1 and 10, an average of 9 weeks apart
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Change in pain central sensitization
기간: Weeks 1 and 10, an average of 9 weeks apart
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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).
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Weeks 1 and 10, an average of 9 weeks apart
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Change in cortisol levels
기간: Weeks 1 and 10, an average of 9 weeks apart
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Collecting blood to measure cortisol levels via enzyme-linked immunosorbent assays (ELISA)
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Weeks 1 and 10, an average of 9 weeks apart
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Change in oxytocin levels
기간: Weeks 1 and 10, an average of 9 weeks apart
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Collecting blood to measure oxytocin levels via enzyme-linked immunosorbent assays (ELISA)
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Weeks 1 and 10, an average of 9 weeks apart
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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music information retrieval (MIR) methods
기간: Weeks 2, 3, 4, 5, 6, 7, 8, and 9, an average of 1 week apart
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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.
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Weeks 2, 3, 4, 5, 6, 7, 8, and 9, an average of 1 week apart
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Change in social connection using State Motivation to Foster Social Connections (SMFSCS)Scale
기간: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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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.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Change in absorption in music using the Absorption in Music Scale (AIMS)
기간: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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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.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Change in absorption in music using the Geriatric Anxiety Scale (GAS)
기간: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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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.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Change in absorption in music using the State-Trait Anxiety Inventory (STAI)
기간: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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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.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Changes in the ratio of low frequency and high frequency (LF/HF) via electrocardiography (ECG, EKG).
기간: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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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.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Changes in Very low frequency (VLF) via electrocardiography (ECG, EKG).
기간: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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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.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Changes in Root Mean Square of Successive Differences (RMSSD) via electrocardiography (ECG, EKG).
기간: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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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.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Changes in Standard Deviation of Normal-to-Normal (SDNN) Interval via electrocardiography (ECG, EKG).
기간: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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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.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Change in absorption in music using the Patient Health Questionnaire-9 (PHQ-9)
기간: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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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.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Change in absorption in music using the Zarit Burden Interview (ZBI)
기간: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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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.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Change in absorption in music using the Quality of Life Scale (QOLS)
기간: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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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.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Change in EEG (brain) activity pre vs post intervention and between experimental and control groups
기간: Weeks 1 and 10, an average of 9 weeks apart
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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
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Weeks 1 and 10, an average of 9 weeks apart
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공동 작업자 및 조사자
스폰서
협력자
수사관
- 수석 연구원: AZA Allsop, MD, PhD, Yale University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2000038702_a
- U24AT012601 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
백치에 대한 임상 시험
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ACADIA Pharmaceuticals Inc.모병Lewy Body Dementia Psychosis미국, 체코, 세르비아, 프랑스, 불가리아, 이탈리아
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ACADIA Pharmaceuticals Inc.초대로 등록
Drumming session에 대한 임상 시험
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Shannon E. Sauer-Zavala완전한