Neural Mechanisms of Clinically Designed Improvisatory Music for Alzheimer's Disease

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Neural Mechanisms of Induced Calmness After Listening to Improvisatory Music: An Investigation for Healthy Individuals and Persons With Alzheimer's Dementia

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Behavioral: Clinically Designed Improvisatory Music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cognitively healthy individuals Cognitively healthy control participants evaluated through the Northwestern Mesulam Center. BAI > 8. Exclusion Criteria: 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) greater than 8, suggestive of at least a mild level of anxiety. Exclusion criteria: MMSE<15, CDR>2, hearing loss

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 15 individuals with Alzheimer Disease (AD) and 15 cognitively healthy individuals.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alzheimer Disease (AD)<br> | Behavioral: Clinically Designed Improvisatory Music<br>* 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.<br>|
| Experimental: Cognitively Healthy (CH)<br> | Behavioral: Clinically Designed Improvisatory Music<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Neuropsychiatric Inventory (NPI) [NPI-1: pre-intervention; NPI-2: post-intervention] | Change in NPI (NPI-2 minus NPI-1) | Through study completion (3 years) | 
| Change in Beck Anxiety Inventory [BAI-1: pre-intervention; BAI-2: post-intervention] | Change in BAI (BAI-2 minus BAI-1) | Through study completion (3 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Blood Pressure [SBP-1: pre-intervention; SBP-2: post-intervention] | Change in SBP (SBP-2 minus SBP-1) | Through study completion (3 years) | 
| Change in Heart rate [HR-1: pre-intervention; HR-2: post-intervention] | Change in HR (HR-2 minus HR-1) | Through study completion (3 years) | 
| Change Respiratory Rate [RR-1: pre-intervention; RR-2: post-intervention] | Change in RR (RR-2 minus RR-1) | Through study completion (3 years) | 
| Change in Skin conductance [SC-1: pre-intervention; SC-2: post-intervention] | Change in SC (SC-2 minus SC-1) | Through study completion (3 years) | 
| Change in Resting state functional connectivity MRI | Functional Connectivity within three resting state networks: Change in Default Network (DN), Change in Salience Network (SN), and Change in Reward Network (RN). | Through study completion (3 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Alzheimer, Dementia, Agitation, Irritability, Music Intervention, Music Medicine, Music Improvisation