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Music for Pain and Dementia (Music4Pain)

15 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

60

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • Connecticut
      • New Haven, Connecticut, Stany Zjednoczone, 06510
        • Rekrutacyjny
        • Connecticut Mental Health Clinic
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: Drumming session
A 45-minute to 1-hour group drumming session
Inny: 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.
Behawioralne: Music-listening session
A 45-minute to 1-hour group music-listening session

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in pain phenotyping using a Quantitative Sensory Testing (QST)
Ramy czasowe: Weeks 1 and 10, an average of 9 weeks apart
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.
Weeks 1 and 10, an average of 9 weeks apart
Change in pain central sensitization
Ramy czasowe: Weeks 1 and 10, an average of 9 weeks apart
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).
Weeks 1 and 10, an average of 9 weeks apart
Change in cortisol levels
Ramy czasowe: Weeks 1 and 10, an average of 9 weeks apart
Collecting blood to measure cortisol levels via enzyme-linked immunosorbent assays (ELISA)
Weeks 1 and 10, an average of 9 weeks apart
Change in oxytocin levels
Ramy czasowe: Weeks 1 and 10, an average of 9 weeks apart
Collecting blood to measure oxytocin levels via enzyme-linked immunosorbent assays (ELISA)
Weeks 1 and 10, an average of 9 weeks apart

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
music information retrieval (MIR) methods
Ramy czasowe: Weeks 2, 3, 4, 5, 6, 7, 8, and 9, an average of 1 week apart
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.
Weeks 2, 3, 4, 5, 6, 7, 8, and 9, an average of 1 week apart
Change in social connection using State Motivation to Foster Social Connections (SMFSCS)Scale
Ramy czasowe: 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 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.
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Change in absorption in music using the Absorption in Music Scale (AIMS)
Ramy czasowe: 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.
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Change in absorption in music using the Geriatric Anxiety Scale (GAS)
Ramy czasowe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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.
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Change in absorption in music using the State-Trait Anxiety Inventory (STAI)
Ramy czasowe: 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.
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Changes in the ratio of low frequency and high frequency (LF/HF) via electrocardiography (ECG, EKG).
Ramy czasowe: 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 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.
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Changes in Very low frequency (VLF) via electrocardiography (ECG, EKG).
Ramy czasowe: 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 Very low frequency (VLF) in people with dementia, mild cognitive impairment, and/or Alzheimer's disease. VLF measure sympathetic responses in milliseconds squared.
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Changes in Root Mean Square of Successive Differences (RMSSD) via electrocardiography (ECG, EKG).
Ramy czasowe: 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 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.
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Changes in Standard Deviation of Normal-to-Normal (SDNN) Interval via electrocardiography (ECG, EKG).
Ramy czasowe: 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.
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Change in absorption in music using the Patient Health Questionnaire-9 (PHQ-9)
Ramy czasowe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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.
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Change in absorption in music using the Zarit Burden Interview (ZBI)
Ramy czasowe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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.
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Change in absorption in music using the Quality of Life Scale (QOLS)
Ramy czasowe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
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.
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, an average of 1 week apart
Change in EEG (brain) activity pre vs post intervention and between experimental and control groups
Ramy czasowe: Weeks 1 and 10, an average of 9 weeks apart
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
Weeks 1 and 10, an average of 9 weeks apart

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Yale University

Współpracownicy

National Center for Complementary and Integrative Health (NCCIH)
Howard University
Renée Fleming Foundation
Yale University School of Medicine, Department of Psychiatry
NeuroArts Blueprint Initiative

Śledczy

  • Główny śledczy: AZA Allsop, MD, PhD, Yale University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 sierpnia 2027

Ukończenie studiów (Szacowany)

1 lutego 2028

Daty rejestracji na studia

Pierwszy przesłany

15 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 maja 2026

Pierwszy wysłany (Rzeczywisty)

22 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2000038702_a
  • U24AT012601 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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