Neural Mechanisms of Induced Calmness After Listening to Improvisatory Music: An Investigation for Healthy Individuals and Persons With Alzheimer's Dementia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Neuropsychiatric Inventory (NPI) [NPI-1: pre-intervention; NPI-2: post-intervention]
研究概览
简要总结
Clinically Designed Improvisatory Music (CDIM) is a form of improvised music based on calm-inducing sound parameters which brought relief to our cohort of neurology patients. As a direct sound-based approach, CDIM does not rely on autobiographical memory and may have wider applicability and generalizability. We wish to examine if CDIM decreases anxiety in 15 cognitively healthy individuals and 15 Alzheimer Disease patients with anxiety (AD-A).
详细描述
The goal of this study is to identify the neural mechanisms of induced calmness through live clinically designed improvisatory music (CDIM) in cognitively healthy individuals and persons with Alzheimer's dementia suffering from agitation. This study is novel as most music interventions for dementia use familiar music and the underlying neural mechanism of calmness induced by music is not well known. We plan to investigate changes in 3 major large-scale brain networks using functional magnetic resonance imaging (fMRI). The major questions we plan to answer are as follows: 1. How does improvisatory music change the connectivity within brain emotion related networks in neurotypical individuals? 2. Does improvisatory music induce a state of calmness in individuals with Alzheimer's dementia and how? Based on objective evidence provided by this study we can justify further usage of music for patients with Alzheimer's, in particular, in the form of improvisation.
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
- 55 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cognitively healthy individuals
- •Cognitively healthy control participants evaluated through the Northwestern Mesulam Center. BAI > 8.
排除标准
- •hearing loss
- •Individuals with mild to moderate Alzheimer's disease
- •This group will similarly be recruited through the Mesulam Center. All individuals recruited by the research Core at the center are well characterized tests standardized across all NIH funded Alzheimer Centers across the nation. Individuals with mild to moderate neurocognitive disorder due to AD will have an MMSE greater than >15 and Clinical Dementia Rating (CDR) between 0.5 and 2.. They will also have a history of neurocognitive-related agitation/anxiety, and a Beck Anxiety Index (BAI) or Rating for Anxiety in Dementia (RAID) greater than 8, suggestive of at least a mild level of anxiety.
- •Exclusion criteria: MMSE<15, CDR>2, hearing loss
研究组 & 干预措施
Cognitively Healthy (CH)
干预措施: Clinically Designed Improvisatory Music (Behavioral)
Alzheimer Disease (AD)
干预措施: Clinically Designed Improvisatory Music (Behavioral)
结局指标
主要结局
Change in Neuropsychiatric Inventory (NPI) [NPI-1: pre-intervention; NPI-2: post-intervention]
时间窗: Through study completion (3 years)
Change in NPI (NPI-2 minus NPI-1)
Change in Beck Anxiety Inventory [BAI-1: pre-intervention; BAI-2: post-intervention]
时间窗: Through study completion (3 years)
Change in BAI (BAI-2 minus BAI-1)
次要结局
- Change in Systolic Blood Pressure [SBP-1: pre-intervention; SBP-2: post-intervention](Through study completion (3 years))
- Change in Skin conductance [SC-1: pre-intervention; SC-2: post-intervention](Through study completion (3 years))
- Change in Heart rate [HR-1: pre-intervention; HR-2: post-intervention](Through study completion (3 years))
- Change in Resting state functional connectivity MRI(Through study completion (3 years))
- Change Respiratory Rate [RR-1: pre-intervention; RR-2: post-intervention](Through study completion (3 years))
研究者
Borna Bonakdarpour
Associate Professor of Neurology
Northwestern University