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SuspendedNCT07638384Updated Sep 8, 2026

Evaluation of Muscle Oxygen With MRI

An interventional study of Compression and Contraction in Muscle Oxygenation, sponsored by Icahn School of Medicine at Mount Sinai. Suspended at 1 site in United States. Open to participants aged 20 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Basic science

Why this study was suspended
Initial data is being analyzed
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
20 Years to 64 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Muscle Oxygenation

Keywords

  • muscle
  • magnetic resonance imaging
  • external pressure
  • muscle contraction
03

In context

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.

Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Latex allergy or allergy to isopropyl alcohol.
  • Skin injury or decreased sensation on right upper extremity.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    MRI

    Participant will undergo a single MRI examination of arm with no contrast.

    Procedure: Compression and Contraction

Interventions

  • ProcedureCompression 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.

06

What researchers measure

Primary outcomes

  1. Muscle oxygen level

    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

    Time frame: Day 1, during procedure

Secondary outcomes

  1. Deep tissue oxygen level

    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.

    Time frame: Day 1, during procedure

07

Study locations

1 site
  • Mount Sinai Hess Center
    New York, New York 10029, United States
08

References and documents

Individual participant data

Plan to share: No — There is no staff available to manage data sharing

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07638384
Lead sponsor
Icahn School of Medicine at Mount Sinai
Responsible party
Yudell Edelstein (Clinical associate professor, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted
Jun 10, 2026
Start date
Aug 18, 2026
Primary completion
May 1, 2029 (estimated)
Completion
May 7, 2029 (estimated)
Last update
Sep 8, 2026

Study contacts

Yudell Edelstein, MD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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