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New device aims to keep ICU Patients' muscles strong

NCT ID NCT07362862

Disease control Sponsor: Health Discovery Labs Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This study tests whether a device called MyokinE100, which sends electrical signals to the thigh muscles, is safe and practical for use in the ICU. It includes 50 critically ill patients with sepsis who are at risk of muscle weakness. Half will receive standard care plus daily 60-minute sessions of electrical stimulation, while the other half gets standard care alone. Researchers will monitor for side effects and measure muscle strength changes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MyokinE100 electrical muscle stimulation device
What this could lead to
If successful, this device could help ICU patients maintain muscle strength and recover faster, reducing long-term disability.
What could go wrong
This is an early feasibility study with only 50 participants, so results may not apply broadly. The device may cause discomfort or skin irritation, and it is not yet proven to prevent weakness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Admitted to ER or ICU within the previous 48 hours * APACHE II score ≥ 13 * Meets the criteria for sepsis or severe sepsis Exclusion Criteria: * Anticipated transfer to an ICU not participating in this study * Myopathies (e.g. congenital) * Acquired myopathies with CK levels 5-times above the upper limit of normal * Unable to transfer from bed to chair at baseline * Moribund * Comfort care * New onset deep vein thrombosis within the previous 6-months * Malignancy in lower limb * Technical obstacles - fracture, burns, amputation * Open wound or skin abrasion at the garment application site * Pregnancy * Pacemaker and implantable cardioverter-defibrillator

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Conditions

The condition(s) this trial relates to.

Critical Illness critical illness polyneuropathy infectious disease with sepsis Sarcopenia Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critical illness Icu acquired weakness Icu-acquired muscle weakness ICUAW Sarcopenia Secondary sarcopenia Sepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ascension Seton Medical Center Austin

    RECRUITING

    Austin, Texas, 78705, United States

  • Dell Seton Medical Center at The University of Texas

    RECRUITING

    Austin, Texas, 78701, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

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