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

Primary Purpose

Alzheimer Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinically Designed Improvisatory Music
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer Disease focused on measuring Anxiety, Alzheimer, Dementia, Agitation, Irritability, Music Intervention, Music Medicine, Music Improvisation

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Cognitively healthy individuals

    Cognitively healthy control participants evaluated through the Northwestern Mesulam Center. BAI > 8.

    Exclusion Criteria: hearing loss

  2. 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Alzheimer Disease (AD)

    Cognitively Healthy (CH)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in Neuropsychiatric Inventory (NPI) [NPI-1: pre-intervention; NPI-2: post-intervention]
    Change in NPI (NPI-2 minus NPI-1)
    Change in Beck Anxiety Inventory [BAI-1: pre-intervention; BAI-2: post-intervention]
    Change in BAI (BAI-2 minus BAI-1)

    Secondary Outcome Measures

    Change in Systolic Blood Pressure [SBP-1: pre-intervention; SBP-2: post-intervention]
    Change in SBP (SBP-2 minus SBP-1)
    Change in Heart rate [HR-1: pre-intervention; HR-2: post-intervention]
    Change in HR (HR-2 minus HR-1)
    Change Respiratory Rate [RR-1: pre-intervention; RR-2: post-intervention]
    Change in RR (RR-2 minus RR-1)
    Change in Skin conductance [SC-1: pre-intervention; SC-2: post-intervention]
    Change in SC (SC-2 minus SC-1)
    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).

    Full Information

    First Posted
    July 17, 2022
    Last Updated
    February 13, 2023
    Sponsor
    Northwestern University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05477862
    Brief Title
    Neural Mechanisms of Clinically Designed Improvisatory Music for Alzheimer's Disease
    Official Title
    Neural Mechanisms of Induced Calmness After Listening to Improvisatory Music: An Investigation for Healthy Individuals and Persons With Alzheimer's Dementia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 15, 2023 (Anticipated)
    Primary Completion Date
    October 15, 2025 (Anticipated)
    Study Completion Date
    January 15, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Northwestern University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer Disease
    Keywords
    Anxiety, Alzheimer, Dementia, Agitation, Irritability, Music Intervention, Music Medicine, Music Improvisation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    15 individuals with Alzheimer Disease (AD) and 15 cognitively healthy individuals.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Alzheimer Disease (AD)
    Arm Type
    Experimental
    Arm Title
    Cognitively Healthy (CH)
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Clinically Designed Improvisatory Music
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Neuropsychiatric Inventory (NPI) [NPI-1: pre-intervention; NPI-2: post-intervention]
    Description
    Change in NPI (NPI-2 minus NPI-1)
    Time Frame
    Through study completion (3 years)
    Title
    Change in Beck Anxiety Inventory [BAI-1: pre-intervention; BAI-2: post-intervention]
    Description
    Change in BAI (BAI-2 minus BAI-1)
    Time Frame
    Through study completion (3 years)
    Secondary Outcome Measure Information:
    Title
    Change in Systolic Blood Pressure [SBP-1: pre-intervention; SBP-2: post-intervention]
    Description
    Change in SBP (SBP-2 minus SBP-1)
    Time Frame
    Through study completion (3 years)
    Title
    Change in Heart rate [HR-1: pre-intervention; HR-2: post-intervention]
    Description
    Change in HR (HR-2 minus HR-1)
    Time Frame
    Through study completion (3 years)
    Title
    Change Respiratory Rate [RR-1: pre-intervention; RR-2: post-intervention]
    Description
    Change in RR (RR-2 minus RR-1)
    Time Frame
    Through study completion (3 years)
    Title
    Change in Skin conductance [SC-1: pre-intervention; SC-2: post-intervention]
    Description
    Change in SC (SC-2 minus SC-1)
    Time Frame
    Through study completion (3 years)
    Title
    Change in Resting state functional connectivity MRI
    Description
    Functional Connectivity within three resting state networks: Change in Default Network (DN), Change in Salience Network (SN), and Change in Reward Network (RN).
    Time Frame
    Through study completion (3 years)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Borna Bonakdarpour, MD, FAAN
    Phone
    3125035170
    Email
    bbk@northwestern.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Clara Takarabe, BA, CMP
    Phone
    3128521282
    Email
    clara.takarabe@northwestern.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34966344
    Citation
    Bonakdarpour B, McFadden A, Zlotkowski S, Huang D, Shaker M, Shibata B, Haben W, Brashear C, Sandoval A, Breitenbach C, Rodriguez C, Viamille J, Porter M, Galic K, Schaeve M, Thatcher D, Takarabe C. Neurology Telemusic Program at the Time of the COVID-19 Pandemic: Turning Hospital Time Into Aesthetic Time During Crisis. Front Neurol. 2021 Dec 13;12:749782. doi: 10.3389/fneur.2021.749782. eCollection 2021.
    Results Reference
    background
    PubMed Identifier
    21889116
    Citation
    Lyketsos CG, Carrillo MC, Ryan JM, Khachaturian AS, Trzepacz P, Amatniek J, Cedarbaum J, Brashear R, Miller DS. Neuropsychiatric symptoms in Alzheimer's disease. Alzheimers Dement. 2011 Sep;7(5):532-9. doi: 10.1016/j.jalz.2011.05.2410.
    Results Reference
    background
    PubMed Identifier
    25725917
    Citation
    Baird A, Samson S. Music and dementia. Prog Brain Res. 2015;217:207-35. doi: 10.1016/bs.pbr.2014.11.028. Epub 2015 Jan 31.
    Results Reference
    background
    PubMed Identifier
    12151841
    Citation
    Assal F, Cummings JL. Neuropsychiatric symptoms in the dementias. Curr Opin Neurol. 2002 Aug;15(4):445-50. doi: 10.1097/00019052-200208000-00007.
    Results Reference
    background
    PubMed Identifier
    17329432
    Citation
    Seeley WW, Menon V, Schatzberg AF, Keller J, Glover GH, Kenna H, Reiss AL, Greicius MD. Dissociable intrinsic connectivity networks for salience processing and executive control. J Neurosci. 2007 Feb 28;27(9):2349-56. doi: 10.1523/JNEUROSCI.5587-06.2007.
    Results Reference
    background

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

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