Music-Based Interventions for Stroke

(OptiMUS Trial)

Overseen By Pablo Ripollés

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Neurological injury, Depression, Visual impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

26 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Heidi Schambra, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for stroke patients aged 18-75 with mild to moderate disability who can move their wrist muscles without help and walk independently. They must have had a stroke at least 6 months prior and agree to MRI procedures. Healthy participants matched in age, gender, and education level to a stroke participant are also eligible.

Inclusion Criteria

I have never had a brain injury.

I had a stroke but can walk on my own and have mild to moderate disability.

For neurologically normal control (NC) participants: consenting to participate and willingness to complete MRI testing procedures

Exclusion Criteria

Amusia as measured by the MBEA

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants complete baseline measures before the music playing task

1 day

1 visit (in-person)

Music Task

Participants perform music playing tasks with variations in improvisation and accompaniment while undergoing fMRI and other measurements

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any delayed effects or responses post-music task

1-2 weeks

Treatment Details

Interventions

• Music Playing Task

Trial Overview The study tests the effects of music playing tasks on motor and emotional responses in individuals post-stroke. Participants will tap a drum while undergoing brain imaging (fMRI) and monitoring of muscle activity (EMG), body movement, and emotional reactions.

Participant Groups

Group I: Order 4 Experimental Treatment 1 Intervention

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 II: Order 3 Experimental Treatment 1 Intervention

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 III: Order 2 Experimental Treatment 1 Intervention

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 IV: Order 1 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+