Study Results
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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ACTIVE_NOT_RECRUITING
NA
80 participants
INTERVENTIONAL
2025-01-10
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
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.
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
55 Years
89 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
University of California, San Francisco
OTHER
Responsible Party
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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
Countries
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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.
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.
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.
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.
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.
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.
Other Identifiers
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23-40419
Identifier Type: -
Identifier Source: org_study_id
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