Clinical trial NCT06215703: Optimizing Music-Based Interventions for Stroke
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
healthy
music
MRI
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-01-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A 2x2 crossover design will be used such that each participant will complete all music playing conditions, including: (1) with or without improvisation and (2) with or without live accompaniment. Participants will be randomized to one of four condition orders.
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Total Acceleration of Hand Movements during Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Total Acceleration of Hand Movements during Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Total Acceleration of Hand Movements during No Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Total Acceleration of Hand Movements during No Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Total Muscle Activation during Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Total Muscle Activation during Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Total Muscle Activation during No Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Total Muscle Activation during No Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Primary Motor Cortex during Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Primary Motor Cortex during Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Primary Motor Cortex during No Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Primary Motor Cortex during No Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Supplementary Motor Cortex during Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Supplementary Motor Cortex during Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Supplementary Motor Cortex during No Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Supplementary Motor Cortex during No Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
Secondary outcomes:
measure: Electrodermal Activity (EDA) during Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Electrodermal Activity (EDA) during Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Electrodermal Activity (EDA) during No Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Electrodermal Activity (EDA) during No Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Music Playing Self-Report Questionnaire - Pleasure Score during Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Music Playing Self-Report Questionnaire - Pleasure Score during Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Music Playing Self-Report Questionnaire - Pleasure Score during No Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Music Playing Self-Report Questionnaire - Pleasure Score during No Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Music Playing Self-Report Questionnaire - Cognitive Challenge Score during Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Music Playing Self-Report Questionnaire - Cognitive Challenge Score during Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Music Playing Self-Report Questionnaire - Cognitive Challenge Score during No Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Music Playing Self-Report Questionnaire - Cognitive Challenge Score during No Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Amygdala during Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Amygdala during Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Amygdala during No Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Amygdala during No Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Ventromedial Prefrontal Cortex during Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Ventromedial Prefrontal Cortex during Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Ventromedial Prefrontal Cortex during No Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Ventromedial Prefrontal Cortex during No Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Ventral Striatum during Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Ventral Striatum during Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Ventral Striatum during No Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Ventral Striatum during No Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Dorsolateral Prefrontal Cortex during Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Dorsolateral Prefrontal Cortex during Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Dorsolateral Prefrontal Cortex during No Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Neural Activation in Dorsolateral Prefrontal Cortex during No Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Functional Connectivity with the Ventral Striatum during Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Functional Connectivity with the Ventral Striatum during Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Functional Connectivity with the Ventral Striatum during No Improvisation + No Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
measure: Functional Connectivity with the Ventral Striatum during No Improvisation + Live Accompaniment Task
timeFrame: Day 1 (About 3 hours)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Heidi Schambra, MD
role: PRINCIPAL_INVESTIGATOR
References: