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NCT Number: NCT07638384

Evaluation of Muscle Oxygen With MRI

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

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Key information

Conditions

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hess Center

New York, 10029, United States

Location status: Recruiting

Location contact

Christopher Cannistraci, MA

CONTACT

[email protected]

(212) 824-8466

Yudell Edelstein, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Compression and Contraction

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yudell Edelstein, MD

CONTACT

[email protected]

212-244-8864

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 10, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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