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Enrolling by Invitation

NCT Number: NCT05477862

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

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).

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Key information

Conditions

Alzheimer Disease Aberrant Motor Behavior in Dementia Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Dyskinesias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms Tauopathies

Age range

55 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mesulam Center for Cognitive Neurology and Alzheimer's Disease

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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) 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

Treatment and study plan

Clinically Designed Improvisatory Music

Behavioral

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 outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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).

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2022
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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