Music, Social Attention, and Dementia

Not Applicable

Recruiting

• Conditions: Frontotemporal Dementia; Alzheimer Disease

• Registration Number: NCT06768996
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2025-01-06
• Study Start: 2025-01-10
• Study First Posted: 2025-01-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-08-31
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Social Attention (TASIT)	Baseline, 2-weeks	Dependent Variable. Change in social attention will be measured by the TASIT, a 16-item instrument that measures social attention from the care recipient perspective. Items are sectioned by emotion recognition, social inference minimum (sarcasm) or enriched (lies) and assessed using standardized yes-no questions at the end of each section based on four types: think, feel, say, or do.
Degree of rhythmic synchronization between dyad-pairs as determined by autocorrelated inter-tap intervals	Through study completion, an average of one year	Independent variable. Degree of rhythmic synchronization will be measured via a musical instrument, digital interface (MIDI) and assessed using an automated data analysis tool created explicitly for the purposes of this study.
Caregiver perceived connectedness questionnaire	Baseline, 2-weeks	A 1-item, 1-7 Likert based scale (1 = very disconnected ... 7 = very connected)
Mutuality Scale	Baseline, 2-weeks	A 15-item instrument using a 0-4 Likert (0 = not at all ... 4 = a great deal) that measures mutuality from the caregiver perspective. Examples include "How close do you feel to the person you care for?" or "How much do you confide in the person you care for?"
Zarit burden	Baseline, 2-weeks	A 12-item instrument using a 0-4 Likert (0 = never ... 4 = nearly always) that measures burden from the caregiver perspective. An example is "Do you feel that your social life has suffered because you are caring for your relative?"
Positive and Negative Experience	Baseline, 2-weeks	A 12-item instrument using a 1-5 Likert (1 = very rarely or never ... 5 = very often or always) that measures an overall affect score that can also be divided into positive and negative feelings. It measures how the participant has felt over the past 4-weeks.
Positive Aspects of Caregiving	Baseline, 2-weeks	A 9-item instrument using a 1-5 Likert (1 = disagree a lot ... 5 = agree a lot) that measures a caregiver's perceptions of their positive experiences in caregiving for their care recipient. An example is "Providing help to \[enter name of care recipient\] has made me feel more useful."
Trait Empathy (Interpersonal Reactivity Index)	Baseline	A 28-item instrument using an A-E Likert (A = does not describe me well ... E = describes me very well) that measures participants' trait empathic disposition. Four dimensions of trait empathy are used: fantasy scale, empathic concert, perspective taking, and personal distress.
Patient Health	Baseline, 2-weeks	A 2-item instrument using a 0-3 Likert (0 = not at all ... 3 = nearly every day) that measures participants' perceived depression over the last 2-weeks.
Revised Self-Monitoring	Baseline, 2-weeks	A 13-item instrument using a 1-5 Likert (1 = ... 5 = ) to measure socioemotional sensitivity and responsiveness to the behavioral expressions of others. An example is "In conversations, the subject is sensitive to even the slightest change in the facial expression of the other person he/she is conversing with."
Self-Compassion	Baseline, 2-weeks	A 12-item instrument using a 1-5 Likert (1 = almost never ... 5 = almost always) to measure an individual's self-compassion. An example is "When I fail at something important to me I become consumed by feelings of inadequacy."
Inclusion of Self in Other	Baseline, 2-weeks	A 7-item instrument using concentric circles (1 = no overlap ... 7 = most overlap) to measure an individual's perceived relationship between self to other.

Secondary Outcome Measures

Name	Time	Method
Patient resting state functional connectivity (RSFC)	From date of completion of collection of all primary outcome measures, assessed up to 24 months	Pre-gathered RSFC will be used in mixed models to determine its predictive potential on rhythm production, social attention, and connectedness.
Perceptions of relationship quality between participants as determined by word frequency analysis of semi-structured interview data	From date of completion of collection of all primary outcome measures, assessed up to 24 months	Semi-structured interviews between participants of the dyad-pair will be analyzed using qualitative data analysis software for word frequencies of subjective and objective perceptions of their relationship with one another.

Trial Locations

Locations (1)

Sandler Neurosciences Center; 🇺🇸 San Francisco, California, United States