Evaluation of Muscle Oxygen With MRI

June 5, 2026 updated by: Yudell Edelstein, Icahn School of Medicine at Mount Sinai

Effect of External Pressure and Muscle Contraction on Soft Tissue Oxygenation Measured With Functional MRI

Demonstration of soft tissue hypoxia on MRI using external compression and muscle contraction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participant will undergo a single MRI examination. Standard orthopedic Sarmiento brace/ shell applied to participant's arm. Inside the brace will be a standard blood pressure cuff with a standard brace soft foam attached; blood pressure cuff will be partially inflated. Participant will also be asked to lift MRI compatible 10 lb. weight. Muscle oxygenation will be actively measured using MRI. No medications are being given, and no invasive devices are being used.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Alert and oriented.
  • Able to lift 10lbs. and hold for 30 seconds
  • Not claustrophobic.
  • Intact sensation in right upper extremity.

Exclusion Criteria:

  • Latex allergy or allergy to isopropyl alcohol.
  • Skin injury or decreased sensation on right upper extremity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI
Participant will undergo a single MRI examination of arm with no contrast.
Other: Compression and Contraction
Standard orthopedic Sarmiento brace/ shell applied to participant's arm. Inside the brace will be a standard blood pressure cuff with a soft foam attached. Pressure will be applied intermittently with blood pressure cuff. Participant will also be asked to lift MRI compatible 10 lb. weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle oxygen level
Time Frame: Day 1, during procedure
Using functional MRI to evaluate effect of muscle compression on muscle oxygen. Demonstrating statistically significant change in muscle oxygen in tissues with application of tissue compression and muscle contraction compared to the same, non-compressed tissues with only muscle contraction
Day 1, during procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deep tissue oxygen level
Time Frame: Day 1, during procedure
Using functional MRI to evaluate the effect of muscle compression and contraction on deep tissue oxygen. Demonstrate statistically greater decreased tissue oxygenation in the deep soft tissues compared to the superficial tissues below the deforming element, during application of tissue compression, during muscle contraction as well during application of tissue compression and muscle contraction.
Day 1, during procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Yudell Edelstein, MD, Icahn School of Medicine at Mount Sinaï

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 7, 2029

Study Registration Dates

First Submitted

June 5, 2026

First Submitted That Met QC Criteria

June 5, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY-26-00124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no staff available to manage data sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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