Neurophysiological and Neuroendocrinal Benefits of Music Based Interventions for Early Alzheimer's Patients and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in pain phenotyping using a Quantitative Sensory Testing (QST)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Drumming session (Behavioral)
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.
干预措施: Music-listening session (Behavioral)
结局指标
主要结局
Change in pain phenotyping using a Quantitative Sensory Testing (QST)
时间窗: 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.
Change in pain central sensitization
时间窗: 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).
Change in cortisol levels
时间窗: Weeks 1 and 10, an average of 9 weeks apart
Collecting blood to measure cortisol levels via enzyme-linked immunosorbent assays (ELISA)
Change in oxytocin levels
时间窗: Weeks 1 and 10, an average of 9 weeks apart
Collecting blood to measure oxytocin levels via enzyme-linked immunosorbent assays (ELISA)
次要结局
- music information retrieval (MIR) methods(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(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)(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)(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)(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).(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).(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).(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).(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)(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)(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)(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(Weeks 1 and 10, an average of 9 weeks apart)