Optimizing Music-Based Interventions for Stroke (OptiMUS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Music Playing Task

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pablo Ripollés; Phone Number: 929-355-0074; Email: pripolles@nyu.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 75 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)
• 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 75 years
• no history of neurological injury
• consenting to participate and willingness to complete MRI testing procedures

Exclusion Criteria:

• history of multiple strokes or neurological injury
• mild cognitive impairment or greater indicated by a Montreal Cognitive Assessment < 26 or <25 for those with <12 years education (Nasreddine et al., 2005)
• 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)
• hearing impairment as indicated by a score > 6 on the revised Hearing Handicap Inventory - Screening (Cassarly et al., 2020)
• visual impairment unable to be corrected with glasses/contact lenses sufficient to allow reading comprehension
• previous expertise in playing music (more than 4 years of musical training)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Order 1; Participants randomized to Order 1 will complete the four music playing tasks in the following order: (1) No improvisation (maintain beat), no live accompaniment (recorded accompaniment); (2) Improvisation, no live accompaniment (recorded accompaniment); (3) No Improvisation (maintain beat), live accompaniment; (4) Improvisation, live accompaniment.	Behavioral: Music Playing Task; 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.
Experimental: Order 2; Participants randomized to Order 2 will complete the four music playing tasks in the following order: (1) Improvisation, no live accompaniment (recorded accompaniment); (2) No improvisation (maintain beat), no live accompaniment (recorded accompaniment); (3) Improvisation, live accompaniment; (4) No improvisation (maintain beat), live accompaniment.	Behavioral: Music Playing Task; 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.
Experimental: Order 3; Participants randomized to Order 3 will complete the four music playing tasks in the following order: (1) No improvisation (maintain beat), live accompaniment; (2) Improvisation, live accompaniment; (3) No improvisation (maintain beat), no live accompaniment (recorded accompaniment); (4) Improvisation, no live accompaniment (recorded accompaniment).	Behavioral: Music Playing Task; 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.
Experimental: Order 4; Participants randomized to Order 3 will complete the four music playing tasks in the following order: (1) Improvisation, live accompaniment; (2) No improvisation (maintain beat), live accompaniment; (3) Improvisation, no live accompaniment (recorded accompaniment); (4) No improvisation (maintain beat), no live accompaniment (recorded accompaniment).	Behavioral: Music Playing Task; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Acceleration of Hand Movements during Improvisation + Live Accompaniment Task	This measurement will be taken using an MRI-compatible accelerometer attached to the hand with a Velcro strap.	Day 1 (About 3 hours)
Total Acceleration of Hand Movements during Improvisation + No Live Accompaniment Task	This measurement will be taken using an MRI-compatible accelerometer attached to the hand with a Velcro strap.	Day 1 (About 3 hours)
Total Acceleration of Hand Movements during No Improvisation + No Live Accompaniment Task	This measurement will be taken using an MRI-compatible accelerometer attached to the hand with a Velcro strap.	Day 1 (About 3 hours)
Total Acceleration of Hand Movements during No Improvisation + Live Accompaniment Task	This measurement will be taken using an MRI-compatible accelerometer attached to the hand with a Velcro strap.	Day 1 (About 3 hours)
Total Muscle Activation during Improvisation + Live Accompaniment Task	This measurement will be taken using MRI-compatible electromyography sensors placed on the arm.	Day 1 (About 3 hours)
Total Muscle Activation during Improvisation + No Live Accompaniment Task	This measurement will be taken using MRI-compatible electromyography sensors placed on the arm.	Day 1 (About 3 hours)
Total Muscle Activation during No Improvisation + No Live Accompaniment Task	This measurement will be taken using MRI-compatible electromyography sensors placed on the arm.	Day 1 (About 3 hours)
Total Muscle Activation during No Improvisation + Live Accompaniment Task	This measurement will be taken using MRI-compatible electromyography sensors placed on the arm.	Day 1 (About 3 hours)
Neural Activation in Primary Motor Cortex during Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.	Day 1 (About 3 hours)
Neural Activation in Primary Motor Cortex during Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.	Day 1 (About 3 hours)
Neural Activation in Primary Motor Cortex during No Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.	Day 1 (About 3 hours)
Neural Activation in Primary Motor Cortex during No Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.	Day 1 (About 3 hours)
Neural Activation in Supplementary Motor Cortex during Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.	Day 1 (About 3 hours)
Neural Activation in Supplementary Motor Cortex during Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.	Day 1 (About 3 hours)
Neural Activation in Supplementary Motor Cortex during No Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.	Day 1 (About 3 hours)
Neural Activation in Supplementary Motor Cortex during No Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.	Day 1 (About 3 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrodermal Activity (EDA) during Improvisation + Live Accompaniment Task	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.	Day 1 (About 3 hours)
Electrodermal Activity (EDA) during Improvisation + No Live Accompaniment Task	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.	Day 1 (About 3 hours)
Electrodermal Activity (EDA) during No Improvisation + No Live Accompaniment Task	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.	Day 1 (About 3 hours)
Electrodermal Activity (EDA) during No Improvisation + Live Accompaniment Task	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.	Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Pleasure Score during Improvisation + Live Accompaniment Task	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.	Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Pleasure Score during Improvisation + No Live Accompaniment Task	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.	Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Pleasure Score during No Improvisation + No Live Accompaniment Task	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.	Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Pleasure Score during No Improvisation + Live Accompaniment Task	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.	Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Cognitive Challenge Score during Improvisation + Live Accompaniment Task	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.	Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Cognitive Challenge Score during Improvisation + No Live Accompaniment Task	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.	Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Cognitive Challenge Score during No Improvisation + No Live Accompaniment Task	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.	Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Cognitive Challenge Score during No Improvisation + Live Accompaniment Task	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.	Day 1 (About 3 hours)
Neural Activation in Amygdala during Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Neural Activation in Amygdala during Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Neural Activation in Amygdala during No Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Neural Activation in Amygdala during No Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Neural Activation in Ventromedial Prefrontal Cortex during Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Neural Activation in Ventromedial Prefrontal Cortex during Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Neural Activation in Ventromedial Prefrontal Cortex during No Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Neural Activation in Ventromedial Prefrontal Cortex during No Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Neural Activation in Ventral Striatum during Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Neural Activation in Ventral Striatum during Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Neural Activation in Ventral Striatum during No Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Neural Activation in Ventral Striatum during No Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Neural Activation in Dorsolateral Prefrontal Cortex during Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Neural Activation in Dorsolateral Prefrontal Cortex during Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Neural Activation in Dorsolateral Prefrontal Cortex during No Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Neural Activation in Dorsolateral Prefrontal Cortex during No Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Functional Connectivity with the Ventral Striatum during Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI). Psychophysiological interactions (PPI) analysis will be used with the seed in the ventral striatum.	Day 1 (About 3 hours)
Functional Connectivity with the Ventral Striatum during Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI). Psychophysiological interactions (PPI) analysis will be used with the seed in the ventral striatum.	Day 1 (About 3 hours)
Functional Connectivity with the Ventral Striatum during No Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI). Psychophysiological interactions (PPI) analysis will be used with the seed in the ventral striatum.	Day 1 (About 3 hours)
Functional Connectivity with the Ventral Striatum during No Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI). Psychophysiological interactions (PPI) analysis will be used with the seed in the ventral striatum.	Day 1 (About 3 hours)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Heidi Schambra, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2024
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: MRI; stroke; music; healthy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 23-01380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: pripolles@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to pripolles@nyu.edu. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No