Clinical trial NCT06768996: Music, Social Attention, and Dementia
Official title: The Impact of a Caregiver-patient Music Intervention on Social Attention and Connectedness in Persons Living With bvFTD and AD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frontotemporal Dementia
Alzheimer Disease
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-01-10
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control-treatment
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: Inclusion (patients)

* 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

Primary outcomes:
measure: Social Attention (TASIT)
timeFrame: Baseline, 2-weeks
measure: Degree of rhythmic synchronization between dyad-pairs as determined by autocorrelated inter-tap intervals
timeFrame: Through study completion, an average of one year
measure: Caregiver perceived connectedness questionnaire
timeFrame: Baseline, 2-weeks
measure: Mutuality Scale
timeFrame: Baseline, 2-weeks
measure: Zarit burden
timeFrame: Baseline, 2-weeks
measure: Positive and Negative Experience
timeFrame: Baseline, 2-weeks
measure: Positive Aspects of Caregiving
timeFrame: Baseline, 2-weeks
measure: Trait Empathy (Interpersonal Reactivity Index)
timeFrame: Baseline
measure: Patient Health
timeFrame: Baseline, 2-weeks
measure: Revised Self-Monitoring
timeFrame: Baseline, 2-weeks
measure: Self-Compassion
timeFrame: Baseline, 2-weeks
measure: Inclusion of Self in Other
timeFrame: Baseline, 2-weeks
Secondary outcomes:
measure: Patient resting state functional connectivity (RSFC)
timeFrame: From date of completion of collection of all primary outcome measures, assessed up to 24 months
measure: Perceptions of relationship quality between participants as determined by word frequency analysis of semi-structured interview data
timeFrame: From date of completion of collection of all primary outcome measures, assessed up to 24 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Sandler Neurosciences Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Aaron Colverson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.