Optimizing Music-Based Interventions for Stroke

NCT ID: NCT06215703

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-16
• Study Completion Date: 2025-02-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Music Playing Task

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Music Playing Task

Intervention Type: 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 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).

Group Type: EXPERIMENTAL

Music Playing Task

Intervention Type: 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 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).

Group Type: EXPERIMENTAL

Music Playing Task

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heidi Schambra, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

23-01380

Identifier Type: -

Identifier Source: org_study_id