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Completed

NCT Number: NCT06215703

Optimizing Music-Based Interventions for Stroke

This study will enroll stroke patients and healthy participants. Participants will complete baseline measures followed by a music playing task during fMRI and simultaneous measurement of motor response using electromyography (EMG) and accelerometry and affective response using electrodermal activity (EDA) and self-reports. The music task consists of tapping an MRI-compatible MIDI drum with either: (1) improvisation or maintaining the beat and (2) live or recorded piano accompaniment. The primary objectives are to identify the motor, affective, and neural outcomes of improvisation and live accompaniment in music playing tasks.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For participants with stroke, to be eligible to participate in this study, an individual must meet all the following criteria:

  • hemiparesis resulting from a stroke (ischemic or hemorrhagic) at least 6 months before the enrollment into the study
  • age from 18 to 89 years
  • ability to move the wrist flexor and extensor muscles without help from the healthy side, scoring above 3 on the Medical Research Council (MRC) Scale for Muscle Strength, reflecting active movement against gravity
  • no more than mild resistance to passive movement in the wrist extensor muscle - as demonstrated by a score <2 on the Ashworth Scale (Brashear et al.., 2002)
  • a modified Rankin Scale (mRS) < 3 indicating moderate to mild disability and the ability to ambulate independently (Bonita & Beaglehole, 1988)
  • ability to comprehend language and provide informed consent
  • consenting to participate and willingness to complete MRI testing procedures

For neurologically normal control (NC) participants, to be eligible to participate in this study, an individual must meet all the following criteria:

  • be matched for age, gender, and socioeconomic status (education level) to a previously enrolled participant with stroke
  • age from 18 to 89 years
  • no history of neurological injury
  • ability to comprehend language and provide informed consent
  • consenting to participate and willingness to complete MRI testing procedures

Exclusion criteria

  • history of neurological injury other than stroke
  • moderate to severe depression symptoms indicated by a score >10 on the Patient Health Questionnaire - 9 (PHQ-9; Koenke et al., 2001; Williams et al., 2005)
  • visual impairment unable to be corrected with glasses/contact lenses sufficient to allow reading comprehension
  • actively performing or practicing a musical instrument more than 2 hours/week
  • musical anhedonia indicated by a score < 65 on the Barcelona Music Reward Questionnaire (BMRQ; Mas-Herrero et al., 2013)
  • amusia as measured by the Montreal Battery of the Evaluation of Amusia (MBEA; Peretz et al., 2003)
  • not being compatible with MRI testing, including having implanted devices, previous exposure to metallic fragments, large tattoos, claustrophobia, and pregnancy

Treatment and study plan

Music Playing Task

Behavioral

For the music playing task, participants will tap on an MRI compatible MIDI drum in response to music, while following directions to either (1) maintain the beat of the music or (2) improvise a beat along with the music. Piano accompaniment for drum playing will be provided either (1) with a recording or (2) by a live music therapist. Participants will complete all four combinations of these music playing tasks following the sequence of experimental order 3. Each of the four tasks will be repeated with four one-minute songs, resulting in a total of 16 minutes of drum playing required to complete the study procedures. Participants will repeat the same task order with each song to facilitate task comprehension and task completion accuracy. Song order will be randomized for all participants.

Primary outcomes

  1. Total Acceleration of Hand Movements during Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    This measurement will be taken using an MRI-compatible accelerometer attached to the hand with a Velcro strap.

  2. Total Acceleration of Hand Movements during Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    This measurement will be taken using an MRI-compatible accelerometer attached to the hand with a Velcro strap.

  3. Total Acceleration of Hand Movements during No Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    This measurement will be taken using an MRI-compatible accelerometer attached to the hand with a Velcro strap.

  4. Total Acceleration of Hand Movements during No Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    This measurement will be taken using an MRI-compatible accelerometer attached to the hand with a Velcro strap.

  5. Total Muscle Activation during Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    This measurement will be taken using MRI-compatible electromyography sensors placed on the arm.

  6. Total Muscle Activation during Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    This measurement will be taken using MRI-compatible electromyography sensors placed on the arm.

  7. Total Muscle Activation during No Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    This measurement will be taken using MRI-compatible electromyography sensors placed on the arm.

  8. Total Muscle Activation during No Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    This measurement will be taken using MRI-compatible electromyography sensors placed on the arm.

  9. Neural Activation in Primary Motor Cortex during Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.

  10. Neural Activation in Primary Motor Cortex during Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.

  11. Neural Activation in Primary Motor Cortex during No Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.

  12. Neural Activation in Primary Motor Cortex during No Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.

  13. Neural Activation in Supplementary Motor Cortex during Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.

  14. Neural Activation in Supplementary Motor Cortex during Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.

  15. Neural Activation in Supplementary Motor Cortex during No Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.

  16. Neural Activation in Supplementary Motor Cortex during No Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.

Secondary outcomes

  1. Electrodermal Activity (EDA) during Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    EDA is a procedure for measuring emotional excitement by recording the skin's natural electrical activity. The measurements will be taken using two MRI-compatible sensors attached to the palm of the hand.

  2. Electrodermal Activity (EDA) during Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    EDA is a procedure for measuring emotional excitement by recording the skin's natural electrical activity. The measurements will be taken using two MRI-compatible sensors attached to the palm of the hand.

  3. Electrodermal Activity (EDA) during No Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    EDA is a procedure for measuring emotional excitement by recording the skin's natural electrical activity. The measurements will be taken using two MRI-compatible sensors attached to the palm of the hand.

  4. Electrodermal Activity (EDA) during No Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    EDA is a procedure for measuring emotional excitement by recording the skin's natural electrical activity. The measurements will be taken using two MRI-compatible sensors attached to the palm of the hand.

  5. Music Playing Self-Report Questionnaire - Pleasure Score during Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    The questionnaire includes 1 question measuring participant's pleasure while performing the music activity. The item is rated on a Likert scale from 1 (low) to 5 (high); higher scores indicate greater pleasure.

  6. Music Playing Self-Report Questionnaire - Pleasure Score during Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    The questionnaire includes 1 question measuring participant's pleasure while performing the music activity. The item is rated on a Likert scale from 1 (low) to 5 (high); higher scores indicate greater pleasure.

  7. Music Playing Self-Report Questionnaire - Pleasure Score during No Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    The questionnaire includes 1 question measuring participant's pleasure while performing the music activity. The item is rated on a Likert scale from 1 (low) to 5 (high); higher scores indicate greater pleasure.

  8. Music Playing Self-Report Questionnaire - Pleasure Score during No Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    The questionnaire includes 1 question measuring participant's pleasure while performing the music activity. The item is rated on a Likert scale from 1 (low) to 5 (high); higher scores indicate greater pleasure.

  9. Music Playing Self-Report Questionnaire - Cognitive Challenge Score during Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    The questionnaire includes 1 question measuring participant's cognitive challenge while performing the music activity. The item is rated on a Likert scale from 1 (low) to 5 (high); higher scores indicate greater cognitive challenge.

  10. Music Playing Self-Report Questionnaire - Cognitive Challenge Score during Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    The questionnaire includes 1 question measuring participant's cognitive challenge while performing the music activity. The item is rated on a Likert scale from 1 (low) to 5 (high); higher scores indicate greater cognitive challenge.

  11. Music Playing Self-Report Questionnaire - Cognitive Challenge Score during No Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    The questionnaire includes 1 question measuring participant's cognitive challenge while performing the music activity. The item is rated on a Likert scale from 1 (low) to 5 (high); higher scores indicate greater cognitive challenge.

  12. Music Playing Self-Report Questionnaire - Cognitive Challenge Score during No Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    The questionnaire includes 1 question measuring participant's cognitive challenge while performing the music activity. The item is rated on a Likert scale from 1 (low) to 5 (high); higher scores indicate greater cognitive challenge.

  13. Neural Activation in Amygdala during Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI).

  14. Neural Activation in Amygdala during Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI).

  15. Neural Activation in Amygdala during No Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI).

  16. Neural Activation in Amygdala during No Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI).

  17. Neural Activation in Ventromedial Prefrontal Cortex during Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI).

  18. Neural Activation in Ventromedial Prefrontal Cortex during Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI).

  19. Neural Activation in Ventromedial Prefrontal Cortex during No Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI).

  20. Neural Activation in Ventromedial Prefrontal Cortex during No Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI).

  21. Neural Activation in Ventral Striatum during Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI).

  22. Neural Activation in Ventral Striatum during Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI).

  23. Neural Activation in Ventral Striatum during No Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI).

  24. Neural Activation in Ventral Striatum during No Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI).

  25. Neural Activation in Dorsolateral Prefrontal Cortex during Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI).

  26. Neural Activation in Dorsolateral Prefrontal Cortex during Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI).

  27. Neural Activation in Dorsolateral Prefrontal Cortex during No Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI).

  28. Neural Activation in Dorsolateral Prefrontal Cortex during No Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI).

  29. Functional Connectivity with the Ventral Striatum during Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI). Psychophysiological interactions (PPI) analysis will be used with the seed in the ventral striatum.

  30. Functional Connectivity with the Ventral Striatum during Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI). Psychophysiological interactions (PPI) analysis will be used with the seed in the ventral striatum.

  31. Functional Connectivity with the Ventral Striatum during No Improvisation + No Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI). Psychophysiological interactions (PPI) analysis will be used with the seed in the ventral striatum.

  32. Functional Connectivity with the Ventral Striatum during No Improvisation + Live Accompaniment Task

    Time frame: Day 1 (About 3 hours)

    Measured using functional MRI (fMRI). Psychophysiological interactions (PPI) analysis will be used with the seed in the ventral striatum.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Optimizing Music-based Interventions for Stroke: a Mechanistic Crossover Study of the Effects of Music Improvisation and Live Accompaniment on Motor, Autonomic, and Neural Response During a Music Playing Task Among Survivors of Stroke and Matched Healthy Control Participants

Acronym: OptiMUS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2024
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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