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Behavioral Intervention

Order 4 for Stroke (OptiMUS Trial)

N/A
Recruiting
Led By Heidi Schambra, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For neurologically normal control (NC) participants: no history of neurological injury
For participants with stroke: mRS < 3 indicating moderate to mild disability and ability to ambulate independently
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (about 3 hours)
Awards & highlights

OptiMUS Trial Summary

This trial will include stroke patients and healthy individuals who will perform a music task while undergoing brain imaging. The task involves playing a drum and either improvising or following a beat, with live or recorded piano

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this intervention involves non-invasive activities like music playing tasks during fMRI scanning, side effects may include discomfort from staying still for the scan or potential anxiety from being in an enclosed space.

OptiMUS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never had a brain injury.
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I had a stroke but can walk on my own and have mild to moderate disability.
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I am between 18 and 75 years old and have had a stroke.
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My wrist stiffness after stroke is mild, scoring less than 2 on the Ashworth Scale.
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I am between 18 and 75 years old and do not have neurological disorders.
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I can move my wrist muscles on my own and have a muscle strength score above 3.

OptiMUS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (about 3 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (about 3 hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neural Activation in Primary Motor Cortex during Improvisation + Live Accompaniment Task
Neural Activation in Primary Motor Cortex during Improvisation + No Live Accompaniment Task
Neural Activation in Primary Motor Cortex during No Improvisation + Live Accompaniment Task
+13 more
Secondary outcome measures
Electrodermal Activity (EDA) during Improvisation + Live Accompaniment Task
Electrodermal Activity (EDA) during Improvisation + No Live Accompaniment Task
Electrodermal Activity (EDA) during No Improvisation + Live Accompaniment Task
+29 more

OptiMUS Trial Design

4Treatment groups
Experimental Treatment
Group I: Order 4Experimental Treatment1 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 3Experimental Treatment1 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 2Experimental Treatment1 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 1Experimental Treatment1 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.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,528 Total Patients Enrolled
19 Trials studying Stroke
2,126 Patients Enrolled for Stroke
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,780 Total Patients Enrolled
38 Trials studying Stroke
7,730 Patients Enrolled for Stroke
Heidi Schambra, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Stroke
24 Patients Enrolled for Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction for potential participants above 50 years old in this trial?

"For this research project, individuals aged between 18 and 75 are eligible for participation. Notably, there exist a total of 40 trials catering to those under 18 years old and an additional 1078 targeting participants over the age of 65."

Answered by AI

Are researchers currently enrolling participants for this clinical study?

"Indeed, the information available on clinicaltrials.gov indicates that this investigation is actively pursuing eligible candidates. The trial was initially disclosed on February 16th, 2024 and underwent its latest revision on the same day. There is a need to recruit 70 participants from one designated site."

Answered by AI

What is the current number of individuals being admitted into this particular medical trial?

"Indeed, clinicaltrials.gov data affirms the ongoing patient recruitment for this investigation. The trial was first listed on 2/16/2024 and most recently revised on the same date. A total of 70 participants are sought from a single site."

Answered by AI

What are the main goals being pursued in this medical study?

"The primary goal of the research, to be evaluated within approximately 3 hours on Day 1, is to examine Neural Activation in the Primary Motor Cortex during a task involving No Improvisation and Live Accompaniment. Secondary objectives include assessing participants' cognitive challenge levels using a Music Playing Self-Report Questionnaire during tasks without improvisation or live accompaniment. Functional Connectivity with the Ventral Striatum will also be examined under similar conditions through functional MRI (fMRI) analysis utilizing Psychophysiological interactions (PPI). Additionally, Neural Activation in the Amygdala will be scrutinized during activities that involve No Improvisation paired"

Answered by AI

Is it feasible for me to participate in this clinical trial?

"The research study is recruiting 70 individuals aged between 18 and 75 who have experienced a stroke. Eligible participants should meet the following criteria: be within the specified age range, exhibit minimal resistance to wrist extensor muscle movement - scoring <2 on the Ashworth Scale (Brashear et al., 2002), demonstrate hemiparesis due to a stroke that occurred at least six months prior (either ischemic or hemorrhagic), possess independent mobility of the wrist flexor and extensor muscles without assistance from the unaffected side, achieve an MRC score above 3 for muscle strength indicating active motion against gravity, maintain an"

Answered by AI
~23 spots leftby May 2024