Optimizing Music-Based Interventions for Stroke

NCT06215703 | Completed

• 1 other identifier: 23-01380
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; healthy; music; MRI

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (32)

• Electrodermal Activity (EDA) during Improvisation + Live Accompaniment Task

  Day 1 (About 3 hours)

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

  Day 1 (About 3 hours)

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

  Day 1 (About 3 hours)

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

  Day 1 (About 3 hours)

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

  Day 1 (About 3 hours)

Study Arms (4)

Order 1

EXPERIMENTAL

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

Order 2

EXPERIMENTAL

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

Order 3

EXPERIMENTAL

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

Order 4

EXPERIMENTAL

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

Interventions

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.

Order 1; Order 2; Order 3; Order 4

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Heidi Schambra, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: February 16, 2024
• Primary Completion: February 8, 2025
• Study Completion: February 8, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)