Status:
COMPLETED
Safety and Efficacy of the MyokinE100 (CL-EMS Alpha) Device in Inducing Visible Muscle Contraction in Healthy Volunteers
Lead Sponsor:
Health Discovery Labs
Collaborating Sponsors:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
University of Texas at Austin
Conditions:
ICU Acquired Weakness
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 durati...
Detailed Description
Every patient admitted to the ICU is at risk of developing ICU Acquired Weakness (ICUAW). ICUAW begins within the first couple hours of hospitalization with approximately 11% of muscle strength is los...
Eligibility Criteria
Inclusion
- Inclusion:
- Male or female
- Age 18 to 65
- Healthy volunteers with no significant past medical history
- Exclusion:
- History of heart disease
- Family history of sudden cardiac death
- History of neurological or neuromuscular diseases, or genetic muscular disorders
- History of deep vein thrombosis
- Presence of implantable devices
- Recent hospitalization within the last 3-months (surgical or medical)
- Pregnancy
- Allergy to latex
- Allergy to carbon-based electrodes
Exclusion
Key Trial Info
Start Date :
August 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06023511
Start Date
August 22 2023
End Date
August 23 2023
Last Update
September 26 2023
Active Locations (1)
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1
Ascension Texas Clinical Education Center (CEC)
Austin, Texas, United States, 78701