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

March 20, 2024 updated by: Borna Bonakdarpour, Northwestern University

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

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).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Mesulam Center for Cognitive Neurology and Alzheimer's Disease

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alzheimer Disease (AD)
Behavioral: Clinically Designed Improvisatory Music
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.
Experimental: Cognitively Healthy (CH)
Behavioral: Clinically Designed Improvisatory Music
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neuropsychiatric Inventory (NPI) [NPI-1: pre-intervention; NPI-2: post-intervention]
Time Frame: Through study completion (3 years)
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]
Time Frame: Through study completion (3 years)
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]
Time Frame: Through study completion (3 years)
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]
Time Frame: Through study completion (3 years)
Change in HR (HR-2 minus HR-1)
Through study completion (3 years)
Change Respiratory Rate [RR-1: pre-intervention; RR-2: post-intervention]
Time Frame: Through study completion (3 years)
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]
Time Frame: Through study completion (3 years)
Change in SC (SC-2 minus SC-1)
Through study completion (3 years)
Change in Resting state functional connectivity MRI
Time Frame: Through study completion (3 years)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Borna Bonakdarpour, MD, FAAN, Northwestern Mesulam Center for Cognitive Neurology and Alzheimer Disease

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2023

Primary Completion (Estimated)

October 15, 2025

Study Completion (Estimated)

January 15, 2026

Study Registration Dates

First Submitted

July 17, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00215983

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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