Optimizing Music-Based Interventions for Stroke

Stroke Clinical Trial

— OptiMUS  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06215703
• Other study ID #: 23-01380
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2024
• Est. completion date: May 31, 2024

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: Pablo Ripollés
• Phone: 929-355-0074
• Email: pripolles[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Neural Activation in Amygdala during Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Secondary	Neural Activation in Amygdala during Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Secondary	Neural Activation in Amygdala during No Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Secondary	Neural Activation in Amygdala during No Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Secondary	Neural Activation in Ventromedial Prefrontal Cortex during Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Secondary	Neural Activation in Ventromedial Prefrontal Cortex during Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Secondary	Neural Activation in Ventromedial Prefrontal Cortex during No Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Secondary	Neural Activation in Ventromedial Prefrontal Cortex during No Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Secondary	Neural Activation in Ventral Striatum during Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Secondary	Neural Activation in Ventral Striatum during Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Secondary	Neural Activation in Ventral Striatum during No Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Secondary	Neural Activation in Ventral Striatum during No Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Secondary	Neural Activation in Dorsolateral Prefrontal Cortex during Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Secondary	Neural Activation in Dorsolateral Prefrontal Cortex during Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Secondary	Neural Activation in Dorsolateral Prefrontal Cortex during No Improvisation + No Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Secondary	Neural Activation in Dorsolateral Prefrontal Cortex during No Improvisation + Live Accompaniment Task	Measured using functional MRI (fMRI).	Day 1 (About 3 hours)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)