Music for Pain and Dementia (Music4Pain)
10 de junio de 2026 actualizado por: Yale University
Neurophysiological and Neuroendocrinal Benefits of Music Based Interventions for Early Alzheimer's Patients and Their Caregivers
This study aims to provide mechanistic insights into how group drumming as a music-based intervention (MBI) affects pain responses and nociceptive function in individuals with Alzheimer's Disease (AD), mild dementia or mild cognitive impairment (MCI).
Heart rate (HR), heart rate variability (HRV), and brain activity will be measured during communal drumming with their dyadic partners and others.
Brain activity, blood pressure, cognitive abilities, blood hormone levels, and static and dynamic pain will also be measured during sessions pre and post the 8-week community drum circle.
Investigators will leverage various measurement techniques including, but not limited to, electroencephalography (EEG), quantitative sensory testing (QST), behavioral, surveys, and physiological monitoring to study the impact of group drumming on pain and brain activity in AD and inter-dyad synchrony.
Descripción general del estudio
Estado
Estado
Reclutamiento
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Analysis of recordings captured during drum circles will be conducted using music information retrieval, pulse clarity, psychological ethnography, and similar methods. Investigators hypothesize that (1) the communal drum circles will lead to a decrease in dynamic pain (e.g. sensitivity to repeated stimuli), (2) the ability of the brain to change and adapt will be enhanced in the drumming group compared to the control group, (3) change in and synchrony of heart rate between participants might underlie the impact of communal drumming on pain, and (4) group drumming will increase circulating oxytocin and serotonin and that the modulation of these neurohormones contribute to decreased pain phenomenon.
The primary objective of this study is to investigate how group drumming affects pain responses and nociceptive function in individuals with mild dementia or mild cognitive impairment.
The secondary objectives of this study are to:
- Use quantitative sensory testing (QST) and blood sampling to investigate potential effects of communal drumming on static and dynamic pain and endocrine hormone variability in individuals with dementia.
- Understand neurophysiological changes (i.e. changes in EEG assessments) that may underlie the effects of an 8-week drum circle on pain, endocrinology, and variations in neurobiology in those living with dementia.
- Analyze phase synchrony between dementia participants and their caregivers before and after the intervention to assess shifts in brain synchrony dynamics.
- Analyze heart rate and heart rate variability parameters during group drumming and characterize changes in autonomic nervous system activity within and across group drum sessions.
- Analyze audio recording data to identify behavioral and auditory synchrony dynamics throughout the communal drumming intervention.
In-person sessions of the study will be conducted by Yale IRB-approved study team members at the Connecticut Mental Health Center (CMHC; 34 Park St, New Haven, CT 06519).
Each participant pair, consisting of one person with dementia and chronic pain (or without chronic pain in the control group) and their caregiver/study partner will take part in ten weekly sessions.
During Week 1, participants will arrive to the CMHC to undergo deep phenotyping of pain using QST, blood sampling, brain activity recordings will be performed for baseline and plasticity analysis, and participants will fill out psychometric assessments (~3 hours). Participants will also be asked to complete communication/language assessments.
During Weeks 2 through 9, participants in the experimental group will be asked to arrive to the CMHC to participate in 45-minute to 1-hour drumming sessions. Participants in the control group will participate in a listening activity. All participants with be asked to complete psychometric assessments before and after the drumming sessions.
During Week 10, participants will return to the CMHC for deep phenotyping of pain, bloodwork, EEG data collection, and psychometric surveys, and communication/language assessments.
Collection of these data allow investigators to assess the impact of communal drumming on brain activity, heart rate, pain perception, psychological symptoms, blood hormone levels, and communication/language.
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Estimado)
Inscripción
60
Fase
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: AZA Allsop, MD, PhD
- Número de teléfono: 240-422-3289
- Correo electrónico: Aza.allsop@yale.edu
Copia de seguridad de contactos de estudio
- Nombre: AZA Lab
- Número de teléfono: 203-903-2157
- Correo electrónico: azalab@yale.edu
Ubicaciones de estudio
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06510
- Reclutamiento
- Connecticut Mental Health Clinic
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Contacto:
- Chief Operating Officer
- Número de teléfono: 203-974-7086
- Correo electrónico: robert.cole@yale.edu
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Clinical Dementia Rating 0.5 - 2
- Be a person with or caregiver to a person with a diagnosis of early Alzheimer's Disease, mild dementia, and/or mild cognitive impairment (MCI) and chronic pain defined as non-cancer pain lasting >3 months that occurs most days and limits life or work activities OR Be a caregiver to a person with a diagnosis of early Alzheimer's Disease, mild dementia, and/or mild cognitive impairment (MCI) and chronic pain defined as non-cancer pain lasting >3 months that occurs most days and limits life or work activities
- Able to provide informed consent
- Willing to wear an EEG headset and heart rate monitoring devices
- Willing to answer survey questions about topics related to the study
- Willing to be audio / video recorded
- Willing to undergo QST, blood draw, heart rate data collection and cognitive testing
Exclusion Criteria:
- Clinical Dementia Rating <0.5 or > 2
- Unable to provide informed consent
- Endorsing suicidal ideation (SI), self-injurious behavior, or homicidal ideation (HI) above the threshold defined in the "Risk Reduction and Safety Plan"
- Participating in another clinical trial studying AD and/or Dementia
- Starting a new prescription medication in the last 4 weeks
- Taking central nervous system acting medications that may interfere with study measurements as determined at PI discretion
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
2
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: AD / Dementia / MCI participants with chronic pain and caregivers dyads
Each participant pair will take part in ten weekly sessions. All sessions will last up to 3 hours. During Week 1, participants will have physiological, bloodwork, communication/language, pain sensitivity, and survey data collected to assess baseline levels of brain activity, heart rate, blood hormones, cognition, dynamic pain, and psychological symptoms. In Weeks 2 through 9, participants will participate in a 45-minute to 1-hour drumming session during which investigators will collect heart data. Psychometric survey data will be collected before and after each session. During Week 10, participants will have physiological, bloodwork, communication/language, pain sensitivity, and survey data collected to assess post-intervention levels of brain activity, heart rate, blood hormones, cognition, dynamic pain, and psychological symptoms. |
A 45-minute to 1-hour group drumming session
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Otro: AD / Dementia / MCI participants without chronic pain and caregivers dyads
Each participant pair will take part in ten weekly sessions. All sessions will last up to 3 hours. During Week 1, participants will have physiological, bloodwork, communication/language, pain sensitivity, and survey data collected to assess baseline levels of brain activity, heart rate, blood hormones, cognition, dynamic pain, and psychological symptoms. In Weeks 2 through 9, participants will participate in a 45-minute to 1-hour music-listening session during which investigators will collect heart data. Psychometric survey data will be collected before and after each session. During Week 10, participants will have physiological, bloodwork, communication/language, pain sensitivity, and survey data collected to assess post-intervention levels of brain activity, heart rate, blood hormones, cognition, dynamic pain, and psychological symptoms. |
A 45-minute to 1-hour group music-listening session
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in pain phenotyping using a Quantitative Sensory Testing (QST)
Periodo de tiempo: Weeks 1 and 10, an average of 9 weeks apart
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Pain phenotyping before and after the intervention using a Quantitative Sensory Testing (QST).
QST will be used to measure pain threshold (the point at which pain is first felt) and pain tolerance (the point at which the participant discontinues the test due to pain).
The battery includes several nociceptive modalities such as pressure, mechanical, heat, and cold stimuli.
The main outcome will be a composite pain sensitivity measure, integrating data from the QST battery.
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Weeks 1 and 10, an average of 9 weeks apart
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Change in pain central sensitization
Periodo de tiempo: Weeks 1 and 10, an average of 9 weeks apart
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Quanititative sensory testing (QST) will be used to assess central sensitization before and after an 8-week drum circle intervention.
A central sensitization score will be generated by averaging mechanical temporal summation (TSP), thermal TSP, and conditioned pain modulation (CPM).
Negative values will denote antinociception, and positive values will denote pronociception (or central sensitization).
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Weeks 1 and 10, an average of 9 weeks apart
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Change in cortisol levels
Periodo de tiempo: Weeks 1 and 10, an average of 9 weeks apart
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Collecting blood to measure cortisol levels via enzyme-linked immunosorbent assays (ELISA)
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Weeks 1 and 10, an average of 9 weeks apart
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Change in oxytocin levels
Periodo de tiempo: Weeks 1 and 10, an average of 9 weeks apart
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Collecting blood to measure oxytocin levels via enzyme-linked immunosorbent assays (ELISA)
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Weeks 1 and 10, an average of 9 weeks apart
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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music information retrieval (MIR) methods
Periodo de tiempo: Weeks 2, 3, 4, 5, 6, 7, 8, and 9, an average of 1 week apart
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Analyzing the physical characteristics of the drumming played during the sessions via music information retrieval (MIR) methods help the researchers make inferences about what musical parameters modulate wellbeing, connectedness, and behavior in this population.
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Weeks 2, 3, 4, 5, 6, 7, 8, and 9, an average of 1 week apart
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Change in social connection using State Motivation to Foster Social Connections (SMFSCS)Scale
Periodo de tiempo: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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SMFSCS is a self-report questionnaire that measures the motivation individuals feel to form new connections and foster existing connection with others.
10 items on a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree).
Total score is achieved by summing all items with total score range from 10-100.
Higher scores indicate a greater motivation to create new connections and foster existing connections with others.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Change in absorption in music using the Absorption in Music Scale (AIMS)
Periodo de tiempo: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
|
SMFSCS is a self-report questionnaire that measures an individual's tendency to have strong emotional responses to music.
35 items on a 5-point Likert scale, from 1 (strongly disagree) to 5 (strongly agree).
Total score is achieved by summing all items with total score range from 35-175.
Higher scores indicate a greater tendency to have strong emotional responses to music.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Change in absorption in music using the Geriatric Anxiety Scale (GAS)
Periodo de tiempo: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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GAS is a self-report questionnaire that serves as a measure of anxiety for use with older adults.
30 items on a 5-point Likert scale, from 0 (not at all) to 3 (all of the time).
Total score is achieved by summing items 1-25 with total score range from 0-75.
Items 26 through 30 are used to help clinicians identify areas of concern for the respondent.
Higher scores indicate more feelings of anxiety or stress.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Change in absorption in music using the State-Trait Anxiety Inventory (STAI)
Periodo de tiempo: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
|
STAI is a self-report questionnaire that measures transient and enduring levels of anxiety.
20 items on a 5-point Likert scale, from 1 (not at all) to 4 (very much so).
Ten items are formed to record the presence of anxiety symptoms and the other 10 items are scored to record the absence of anxiety symptoms.
Total score is achieved by summing all presence of anxiety items and inverting the absence of anxiety items with total score range from 20-80.
Higher scores indicate higher levels transient and enduring anxiety.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Changes in the ratio of low frequency and high frequency (LF/HF) via electrocardiography (ECG, EKG).
Periodo de tiempo: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure the ratio of low frequency (sympathetic response) and high frequency (parasympathetic response).
This unitless measure is abbreviated as LF/HF and informs the researchers about the relationship between the SNS and PNS.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Changes in Very low frequency (VLF) via electrocardiography (ECG, EKG).
Periodo de tiempo: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure Very low frequency (VLF) in people with dementia, mild cognitive impairment, and/or Alzheimer's disease.
VLF measure sympathetic responses in milliseconds squared.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Changes in Root Mean Square of Successive Differences (RMSSD) via electrocardiography (ECG, EKG).
Periodo de tiempo: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure the Root Mean Square of Successive Differences (RMSSD) in people with dementia, mild cognitive impairment, and/or Alzheimer's disease.
RMSSD measure parasympathetic responses in milliseconds.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Changes in Standard Deviation of Normal-to-Normal (SDNN) Interval via electrocardiography (ECG, EKG).
Periodo de tiempo: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
|
Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure the standard deviation of Normal-to-Normal (SDNN) Interval in people with dementia, mild cognitive impairment, and/or Alzheimer's disease.
SDNN Intervals measure both sympathetic and parasympathetic nervous system (SNS & PNS) responses (primarily sympathetic) in milliseconds.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Change in absorption in music using the Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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PHQ-9 is a self-report questionnaire that assesses 8 DSM-IV diagnoses, divided into threshold disorders and subthreshold disorders.
9 items on a 4-point Likert scale, from 0 (not at all) to 3 (nearly everyday).
An item was also added to the end of the diagnostic portion of the PHQ-9 asking patients who checked off any problems on the questionnaire how difficult these symptoms make the respondent's life.
Total score is achieved by summing all items with total score range from 0-27.
Higher scores indicate higher depression severity.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Change in absorption in music using the Zarit Burden Interview (ZBI)
Periodo de tiempo: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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ZBI is a self-report questionnaire that measures the level of burden experienced by caregivers of patients with dementia.
22 items on a 5-point Likert scale, from 0 (never) to 4 (nearly always).
Total score is achieved by summing all items with total score range from 0-88.
Higher scores indicate greater burden.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Change in absorption in music using the Quality of Life Scale (QOLS)
Periodo de tiempo: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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QOLS is a self-report questionnaire that measures 5 conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation.
16 items on a 7-point Likert scale, from 1 (terrible) to 7 (delighted).
Total score is achieved by summing all items with total score range from 16-112.
Higher scores indicate a greater satisfaction with life.
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Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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Change in EEG (brain) activity pre vs post intervention and between experimental and control groups
Periodo de tiempo: Weeks 1 and 10, an average of 9 weeks apart
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EEG gamma measured by the Post Spectral Density measures in the gamma range (>30Hz) and theta (4-8Hz) frequency ranges pre and post drumming intervention
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Weeks 1 and 10, an average of 9 weeks apart
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: AZA Allsop, MD, PhD, Yale University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
9 de junio de 2026
Finalización primaria (Estimado)
Finalización primaria
1 de agosto de 2027
Finalización del estudio (Estimado)
Finalización del estudio
1 de febrero de 2028
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
15 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
15 de mayo de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
22 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
12 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
10 de junio de 2026
Última verificación
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 2000038702_a
- U24AT012601 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .