Muscle OxygenationNCT07638384
Evaluation of Muscle Oxygen With MRI
A study testing Compression and Contraction in people with Muscle Oxygenation, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Demonstration of soft tissue hypoxia on MRI using external compression and muscle contraction. Read more about this study
- Who is it for?
- Ages 20 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Oxygenation
- What is being tested?
- Compression and Contraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2026to 7 May 2029
- Phase
- Interventional
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 20 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Alert and oriented.
- Able to lift 10lbs. and hold for 30 seconds
- Not claustrophobic.
- Intact sensation in right upper extremity.
Who cannot join
- Latex allergy or allergy to isopropyl alcohol.
- Skin injury or decreased sensation on right upper extremity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Muscle Oxygenation
- Being tested
- Compression and Contraction
- Keywords
- muscle, magnetic resonance imaging, external pressure, muscle contraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression and ContractionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| MRI | Experimental | Participant will undergo a single MRI examination of arm with no contrast. Receives: Procedure: Compression and Contraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Day 1, during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start18 Aug 2026
- Primary completion1 May 2029 (estimated)
- Study completion7 May 2029 (estimated)
Why it stopped: Initial data is being analyzed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle OxygenationStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yudell Edelstein, Icahn School of Medicine at Mount Sinai
- Investigators
- Yudell Edelstein, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638384
- Sponsor's protocol ID
- STUDY-26-00124
- Status last verified
- Sep 2026
- First submitted
- 5 Jun 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no staff available to manage data sharing