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Safety and Efficacy of the MyokinE100 (CL-EMS Alpha) Device in Inducing Visible Muscle Contraction in Healthy Volunteers

NCT06023511 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-09-26

No results posted yet for this study

Summary

Every patient admitted to the Intensive Care Unit (ICU) is at risk of developing "Intensive Care Unit Acquired Weakness" (ICUAW). ICUAW is associated with increased rate of mortality, prolonged duration of mechanical ventilation, ICU and hospital stay, rehabilitation time, and reduced quality of life. Currently, there is no effective treatment for ICUAW.

Health Discovery Labs is conducting a research study to evaluate the safety of using an innovative experimental medical device in ICU settings that could mitigate ICUAW.

This study is meant to demonstrate whether this new device interferes with standard ICU monitors.

Conditions

  • ICU Acquired Weakness

Interventions

DEVICE

Electrical muscle stimulation

While study subjects are connected to standard ICU monitors, electrical muscle stimulation will be applied at the level of the quadriceps muscle to induce palpable or visible muscle contraction. (No control group or sham procedure in this study).

Sponsors & Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

    collaborator NIH

  • University of Texas at Austin

    collaborator OTHER

  • Ascension Health

    collaborator INDUSTRY

  • Health Discovery Labs

    lead INDUSTRY

Principal Investigators

  • Oussama Hassan, MD · Health Discovery Labs LLC

  • Paul Harford, MD · Dell Medical School at The University of Texas at Austin

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-22
Primary Completion
2023-08-23
Completion
2023-08-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06023511 on ClinicalTrials.gov