StrokeOptiMUSNCT06215703
Optimizing Music-Based Interventions for Stroke
A study testing Music Playing Task in people with Stroke, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Music Playing Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2024to 8 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 14Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Music Playing Task
- Keywords
- stroke, healthy, music, MRI
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Playing TaskBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: 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). Receives: Behavioral: Music Playing Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 (About 3 hours)
Secondary outcomes (32)
Electrodermal Activity (EDA) during Improvisation + Live Accompaniment Task
EDA is a procedure for measuring emotional excitement by recording the skin's natural electrical activity. The measurements will be taken using two MRI-compatible sensors attached to the palm of the hand.
Measured: Day 1 (About 3 hours)
Electrodermal Activity (EDA) during Improvisation + No Live Accompaniment Task
EDA is a procedure for measuring emotional excitement by recording the skin's natural electrical activity. The measurements will be taken using two MRI-compatible sensors attached to the palm of the hand.
Measured: Day 1 (About 3 hours)
Electrodermal Activity (EDA) during No Improvisation + No Live Accompaniment Task
EDA is a procedure for measuring emotional excitement by recording the skin's natural electrical activity. The measurements will be taken using two MRI-compatible sensors attached to the palm of the hand.
Measured: Day 1 (About 3 hours)
Electrodermal Activity (EDA) during No Improvisation + Live Accompaniment Task
EDA is a procedure for measuring emotional excitement by recording the skin's natural electrical activity. The measurements will be taken using two MRI-compatible sensors attached to the palm of the hand.
Measured: Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Pleasure Score during Improvisation + Live Accompaniment Task
The questionnaire includes 1 question measuring participant's pleasure while performing the music activity. The item is rated on a Likert scale from 1 (low) to 5 (high); higher scores indicate greater pleasure.
Measured: Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Pleasure Score during Improvisation + No Live Accompaniment Task
The questionnaire includes 1 question measuring participant's pleasure while performing the music activity. The item is rated on a Likert scale from 1 (low) to 5 (high); higher scores indicate greater pleasure.
Measured: Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Pleasure Score during No Improvisation + No Live Accompaniment Task
The questionnaire includes 1 question measuring participant's pleasure while performing the music activity. The item is rated on a Likert scale from 1 (low) to 5 (high); higher scores indicate greater pleasure.
Measured: Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Pleasure Score during No Improvisation + Live Accompaniment Task
The questionnaire includes 1 question measuring participant's pleasure while performing the music activity. The item is rated on a Likert scale from 1 (low) to 5 (high); higher scores indicate greater pleasure.
Measured: Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Cognitive Challenge Score during Improvisation + Live Accompaniment Task
The questionnaire includes 1 question measuring participant's cognitive challenge while performing the music activity. The item is rated on a Likert scale from 1 (low) to 5 (high); higher scores indicate greater cognitive challenge.
Measured: Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Cognitive Challenge Score during Improvisation + No Live Accompaniment Task
The questionnaire includes 1 question measuring participant's cognitive challenge while performing the music activity. The item is rated on a Likert scale from 1 (low) to 5 (high); higher scores indicate greater cognitive challenge.
Measured: Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Cognitive Challenge Score during No Improvisation + No Live Accompaniment Task
The questionnaire includes 1 question measuring participant's cognitive challenge while performing the music activity. The item is rated on a Likert scale from 1 (low) to 5 (high); higher scores indicate greater cognitive challenge.
Measured: Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Cognitive Challenge Score during No Improvisation + Live Accompaniment Task
The questionnaire includes 1 question measuring participant's cognitive challenge while performing the music activity. The item is rated on a Likert scale from 1 (low) to 5 (high); higher scores indicate greater cognitive challenge.
Measured: Day 1 (About 3 hours)
Neural Activation in Amygdala during Improvisation + Live Accompaniment Task
Measured using functional MRI (fMRI).
Measured: Day 1 (About 3 hours)
Neural Activation in Amygdala during Improvisation + No Live Accompaniment Task
Measured using functional MRI (fMRI).
Measured: Day 1 (About 3 hours)
Neural Activation in Amygdala during No Improvisation + No Live Accompaniment Task
Measured using functional MRI (fMRI).
Measured: Day 1 (About 3 hours)
Neural Activation in Amygdala during No Improvisation + Live Accompaniment Task
Measured using functional MRI (fMRI).
Measured: Day 1 (About 3 hours)
Neural Activation in Ventromedial Prefrontal Cortex during Improvisation + Live Accompaniment Task
Measured using functional MRI (fMRI).
Measured: Day 1 (About 3 hours)
Neural Activation in Ventromedial Prefrontal Cortex during Improvisation + No Live Accompaniment Task
Measured using functional MRI (fMRI).
Measured: Day 1 (About 3 hours)
Neural Activation in Ventromedial Prefrontal Cortex during No Improvisation + No Live Accompaniment Task
Measured using functional MRI (fMRI).
Measured: Day 1 (About 3 hours)
Neural Activation in Ventromedial Prefrontal Cortex during No Improvisation + Live Accompaniment Task
Measured using functional MRI (fMRI).
Measured: Day 1 (About 3 hours)
Neural Activation in Ventral Striatum during Improvisation + Live Accompaniment Task
Measured using functional MRI (fMRI).
Measured: Day 1 (About 3 hours)
Neural Activation in Ventral Striatum during Improvisation + No Live Accompaniment Task
Measured using functional MRI (fMRI).
Measured: Day 1 (About 3 hours)
Neural Activation in Ventral Striatum during No Improvisation + No Live Accompaniment Task
Measured using functional MRI (fMRI).
Measured: Day 1 (About 3 hours)
Neural Activation in Ventral Striatum during No Improvisation + Live Accompaniment Task
Measured using functional MRI (fMRI).
Measured: Day 1 (About 3 hours)
Neural Activation in Dorsolateral Prefrontal Cortex during Improvisation + Live Accompaniment Task
Measured using functional MRI (fMRI).
Measured: Day 1 (About 3 hours)
Neural Activation in Dorsolateral Prefrontal Cortex during Improvisation + No Live Accompaniment Task
Measured using functional MRI (fMRI).
Measured: Day 1 (About 3 hours)
Neural Activation in Dorsolateral Prefrontal Cortex during No Improvisation + No Live Accompaniment Task
Measured using functional MRI (fMRI).
Measured: Day 1 (About 3 hours)
Neural Activation in Dorsolateral Prefrontal Cortex during No Improvisation + Live Accompaniment Task
Measured using functional MRI (fMRI).
Measured: Day 1 (About 3 hours)
Functional Connectivity with the Ventral Striatum during Improvisation + Live Accompaniment Task
Measured using functional MRI (fMRI). Psychophysiological interactions (PPI) analysis will be used with the seed in the ventral striatum.
Measured: Day 1 (About 3 hours)
Functional Connectivity with the Ventral Striatum during Improvisation + No Live Accompaniment Task
Measured using functional MRI (fMRI). Psychophysiological interactions (PPI) analysis will be used with the seed in the ventral striatum.
Measured: Day 1 (About 3 hours)
Functional Connectivity with the Ventral Striatum during No Improvisation + No Live Accompaniment Task
Measured using functional MRI (fMRI). Psychophysiological interactions (PPI) analysis will be used with the seed in the ventral striatum.
Measured: Day 1 (About 3 hours)
Functional Connectivity with the Ventral Striatum during No Improvisation + Live Accompaniment Task
Measured using functional MRI (fMRI). Psychophysiological interactions (PPI) analysis will be used with the seed in the ventral striatum.
Measured: Day 1 (About 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start16 Feb 2024
- Primary completion8 Feb 2025
- Study completion8 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Heidi Schambra, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215703
- Sponsor's protocol ID
- 23-01380
- Acronym
- OptiMUS
- Status last verified
- Apr 2025
- First submitted
- 11 Jan 2024
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: pripolles@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06215703
- Acronym / sponsor ID
- OptiMUS / 23-01380
- Conditions
- Stroke
- Keywords
- stroke, healthy, music, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 8 Feb 2025 (actual)
- Study completion
- 8 Feb 2025 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Order 1 | Experimental | Behavioral: Music Playing TaskParticipants 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. |
| Order 2 | Experimental | Behavioral: Music Playing TaskParticipants 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. |
| Order 3 | Experimental | Behavioral: Music Playing TaskParticipants 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). |
| Order 4 | Experimental | Behavioral: Music Playing TaskParticipants 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). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Playing TaskFor 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. | Behavioural | Order 1, Order 2, Order 3, Order 4 |
Primary outcome
Total Acceleration of Hand Movements during Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
This measurement will be taken using an MRI-compatible accelerometer attached to the hand with a Velcro strap.
Total Acceleration of Hand Movements during Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
This measurement will be taken using an MRI-compatible accelerometer attached to the hand with a Velcro strap.
Total Acceleration of Hand Movements during No Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
This measurement will be taken using an MRI-compatible accelerometer attached to the hand with a Velcro strap.
Total Acceleration of Hand Movements during No Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
This measurement will be taken using an MRI-compatible accelerometer attached to the hand with a Velcro strap.
Total Muscle Activation during Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
This measurement will be taken using MRI-compatible electromyography sensors placed on the arm.
Total Muscle Activation during Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
This measurement will be taken using MRI-compatible electromyography sensors placed on the arm.
Total Muscle Activation during No Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
This measurement will be taken using MRI-compatible electromyography sensors placed on the arm.
Total Muscle Activation during No Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
This measurement will be taken using MRI-compatible electromyography sensors placed on the arm.
Neural Activation in Primary Motor Cortex during Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.
Neural Activation in Primary Motor Cortex during Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.
Neural Activation in Primary Motor Cortex during No Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.
Neural Activation in Primary Motor Cortex during No Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.
Neural Activation in Supplementary Motor Cortex during Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.
Neural Activation in Supplementary Motor Cortex during Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.
Neural Activation in Supplementary Motor Cortex during No Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.
Neural Activation in Supplementary Motor Cortex during No Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Measured using functional MRI (fMRI). Summary beta values representing the level of brain activity will be calculated.
32 secondary outcomes
Electrodermal Activity (EDA) during Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Electrodermal Activity (EDA) during Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Electrodermal Activity (EDA) during No Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Electrodermal Activity (EDA) during No Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Pleasure Score during Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Pleasure Score during Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Pleasure Score during No Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Pleasure Score during No Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Cognitive Challenge Score during Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Cognitive Challenge Score during Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Cognitive Challenge Score during No Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Music Playing Self-Report Questionnaire - Cognitive Challenge Score during No Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Neural Activation in Amygdala during Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Neural Activation in Amygdala during Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Neural Activation in Amygdala during No Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Neural Activation in Amygdala during No Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Neural Activation in Ventromedial Prefrontal Cortex during Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Neural Activation in Ventromedial Prefrontal Cortex during Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Neural Activation in Ventromedial Prefrontal Cortex during No Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Neural Activation in Ventromedial Prefrontal Cortex during No Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Neural Activation in Ventral Striatum during Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Neural Activation in Ventral Striatum during Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Neural Activation in Ventral Striatum during No Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Neural Activation in Ventral Striatum during No Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Neural Activation in Dorsolateral Prefrontal Cortex during Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Neural Activation in Dorsolateral Prefrontal Cortex during Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Neural Activation in Dorsolateral Prefrontal Cortex during No Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Neural Activation in Dorsolateral Prefrontal Cortex during No Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Functional Connectivity with the Ventral Striatum during Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Functional Connectivity with the Ventral Striatum during Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Functional Connectivity with the Ventral Striatum during No Improvisation + No Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Functional Connectivity with the Ventral Striatum during No Improvisation + Live Accompaniment Task
Time frame: Day 1 (About 3 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: pripolles@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Schambra, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Playing Task in people with Stroke, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Acceleration of Hand Movements during Improvisation + Live Accompaniment Task (time frame: Day 1 (About 3 hours)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.