Music, Social Attention, and Dementia

NCT ID: NCT06768996

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-10

Study Completion Date

2026-12-01

Brief Summary

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This is an exploratory mixed-methods control-treatment study to evaluate if participation in rhythmic musical activities improves social attention and connectedness in individuals living with mild to moderate bvFTD and AD, and their caregivers. Secondary objectives include evaluating the potential relationships between brain networks associated with rhythm production, social attention, and connectedness in these populations.

Detailed Description

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The proposed research will evaluate potential relationships between synchronous rhythm production, social attention, and connectedness in persons living with mild to moderate bvFTD and AD and their caregivers. To evaluate these relationships, the proposed research will include data collection and analysis of the following: 1) pre-post evaluation of social attention and connectedness in individuals living with dementia and their caregivers; 2) control-treatment participation in a synchronous (treatment) or solo (control) rhythm production activity; and 3) secondary analysis of structural and functional MRI of resting state network connectivity between networks of the brain including areas associated with rhythm perception and production, namely the fronto-parietal, executive control, sensorimotor, dorsal and ventral attention networks.

Conditions

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Frontotemporal Dementia Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Control-treatment
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Solo Rhythm Production

Participants randomized to the control condition will complete the same rhythm conditions to the same recorded audio tracks described in the experimental condition. However, they will not interchange their tapping with their caregiver. They will participate in the rhythm task as a solo producer.

Group Type ACTIVE_COMPARATOR

Solo Rhythm Production

Intervention Type BEHAVIORAL

Participants randomized to the control condition will complete the same rhythm conditions to the same recorded audio tracks described in the experimental condition. However, they will not interchange their tapping with their caregiver. They will participate in the rhythm task as a solo producer.

Synchronous Rhythm Production

The treatment group will take part in a dyad-based musical rhythm production activity facilitated by a trained musician. This activity will involve two rhythm conditions. The first condition requires tapping along to one pre-recorded audio track composed of an ensemble of Brazilian percussion instruments. The second condition requires tapping along with prerecorded audio tracks of rhythms progressively increasing in difficulty. Participants who indicate proficiency in learning to tap along in both conditions will be able to progress to more complex rhythms. All tapping data will be gathered through a Roland digital hand percussion controller.

Group Type EXPERIMENTAL

Synchronous Rhythm Production

Intervention Type BEHAVIORAL

The treatment group will take part in a dyad-based musical rhythm production activity facilitated by a trained musician. This activity will involve two rhythm conditions. The first condition requires tapping along to one pre-recorded audio track composed of an ensemble of Brazilian percussion instruments. The second condition requires tapping along with prerecorded audio tracks of rhythms progressively increasing in difficulty. Participants who indicate proficiency in learning to tap along in both conditions will be able to progress to more complex rhythms. All tapping data will be gathered through a Roland digital hand percussion controller.

Interventions

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Synchronous Rhythm Production

The treatment group will take part in a dyad-based musical rhythm production activity facilitated by a trained musician. This activity will involve two rhythm conditions. The first condition requires tapping along to one pre-recorded audio track composed of an ensemble of Brazilian percussion instruments. The second condition requires tapping along with prerecorded audio tracks of rhythms progressively increasing in difficulty. Participants who indicate proficiency in learning to tap along in both conditions will be able to progress to more complex rhythms. All tapping data will be gathered through a Roland digital hand percussion controller.

Intervention Type BEHAVIORAL

Solo Rhythm Production

Participants randomized to the control condition will complete the same rhythm conditions to the same recorded audio tracks described in the experimental condition. However, they will not interchange their tapping with their caregiver. They will participate in the rhythm task as a solo producer.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Male or female ≥ 55 years of age living with bvFTD; or ≥ 70 years of age living with AD.
* Documentation of a bvFTD or AD diagnosis as evidenced by one or more known clinical features.
* Written informed consent obtained from subject.

Inclusion (caregivers)

* Male or female ≥ 55 years of age living without diagnosis of neurological or psychiatric disease.
* Individual capable of independent execution of activities of daily living, including personal care and hygiene, dressing, eating, use of a toilet, and mobility.
* Written informed consent.

Exclusion (patients)

* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* community-dwelling individuals not living with bvFTD

* community-dwelling individuals with normal cognitive functioning
* Individuals living with Alzheimer's disease or related dementias (primary progressive aphasia, semantic variant FTD, Lewy body dementia, vascular dementia, Parkinson's disease, or mixed dementia)
* Individuals with a score of 2 or higher on the CDR
* Individuals with a history of neuropsychiatric illness that would interfere with performance (e.g., transient psych hx of depression okay, hx of schizophrenia will be excluded) or medicated depression to control symptoms.
* Individuals with unstable (e.g., cancer other than basal cell skin) or chronic (e.g., severe diabetes) medical conditions
* Individuals with MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI)
* Individuals with physical impairment(s) precluding motor response
* Individuals with inability to walk two blocks without stopping
* Individuals with hearing or vision deficits that will not allow for completion of testing; inability to hear conversation conducted at an average volume (\~60 dB)
* Individuals who practice music making or production for at least 30-mins per week

* This may include instrumental or vocal, writing or arranging, alone or in groups
* Listening to music for more than 30-mins weekly will not exclude the individual from the study

Exclusion (Caregivers)

* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* Community-dwelling individuals living with diagnosis of a neurological or psychiatric disease

o Community-dwelling individuals with abnormal cognitive functioning
* Individuals living with dementia
* Individuals with a history of neuropsychiatric illness that would interfere with performance (e.g., transient psych hx of depression okay, hx of schizophrenia will be excluded) or medicated depression to control symptoms
* Individuals with unstable (e.g., cancer other than basal cell carcinoma) or chronic (e.g., severe diabetes) medical conditions
* Individuals with physical impairment(s) precluding motor control
* Individuals with inability to walk two blocks without stopping
* Individuals with hearing or vision deficits that will not allow for completion of testing; inability to hear conversation conducted at an average volume (\~60 dB)
* Individuals who practice music making or production for at least 30-mins per week

* This may include instrumental or vocal, writing or arranging, alone or in groups
* Listening to music for more than 30-mins weekly will not exclude the individual from the study
Minimum Eligible Age

55 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aaron Colverson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Sandler Neurosciences Center

San Francisco, California, United States

Site Status

Countries

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United States

References

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Spinosa V, Vitulli A, Logroscino G, Brattico E. A Review on Music Interventions for Frontotemporal Aphasia and a Proposal for Alternative Treatments. Biomedicines. 2022 Dec 29;11(1):84. doi: 10.3390/biomedicines11010084.

Reference Type BACKGROUND
PMID: 36672592 (View on PubMed)

Clarke E, DeNora T, Vuoskoski J. Music, empathy and cultural understanding. Phys Life Rev. 2015 Dec;15:61-88. doi: 10.1016/j.plrev.2015.09.001. Epub 2015 Sep 7.

Reference Type BACKGROUND
PMID: 26419700 (View on PubMed)

Hobeika L, Ghilain M, Schiaratura L, Lesaffre M, Puisieux F, Huvent-Grelle D, Samson S. The effect of the severity of neurocognitive disorders on emotional and motor responses to music. Ann N Y Acad Sci. 2022 Dec;1518(1):231-238. doi: 10.1111/nyas.14923. Epub 2022 Nov 2.

Reference Type BACKGROUND
PMID: 36321882 (View on PubMed)

Hobeika L, Ghilain M, Schiaratura L, Lesaffre M, Huvent-Grelle D, Puisieux F, Samson S. Socio-emotional and motor engagement during musical activities in older adults with major neurocognitive impairment. Sci Rep. 2021 Jul 27;11(1):15291. doi: 10.1038/s41598-021-94686-4.

Reference Type BACKGROUND
PMID: 34315954 (View on PubMed)

Kumfor F, Honan C, McDonald S, Hazelton JL, Hodges JR, Piguet O. Assessing the "social brain" in dementia: Applying TASIT-S. Cortex. 2017 Aug;93:166-177. doi: 10.1016/j.cortex.2017.05.022. Epub 2017 Jun 7.

Reference Type BACKGROUND
PMID: 28662418 (View on PubMed)

Colverson A, Barsoum S, Cohen R, Williamson J. Rhythmic musical activities may strengthen connectivity between brain networks associated with aging-related deficits in timing and executive functions. Exp Gerontol. 2024 Feb;186:112354. doi: 10.1016/j.exger.2023.112354. Epub 2024 Jan 3.

Reference Type BACKGROUND
PMID: 38176601 (View on PubMed)

Other Identifiers

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T32AG078115

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-40419

Identifier Type: -

Identifier Source: org_study_id

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