Optimizing Music-Based Interventions for Stroke (OptiMUS)

NYU Langone Health

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Music Playing Task

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06215703

23-01380

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 4 patient groups

Order 1

Experimental group

Description:

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.

Treatment:

Behavioral: Music Playing Task

Order 2

Experimental group

Description:

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.

Treatment:

Behavioral: Music Playing Task

Order 3

Experimental group

Description:

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).

Treatment:

Behavioral: Music Playing Task

Order 4

Experimental group

Description:

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).

Treatment:

Behavioral: Music Playing Task