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

NCT06023511 | Completed FDA Device

• 1 other identifier: STUDY00004235
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 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

Keywords

Muscle weakness; Critical care myopathy; Electrical muscle stimulation; Electromagnetic interference; ICU monitoring

Outcome Measures

Primary Outcomes (1)

• Interference with cardiac monitoring devices: detection of ECG noise of more than 0.1mV in amplitude or ECG changes suggestive of cardiac dysrhythmias

  During electrical muscle stimulation using the MyokinE100 (CL-EMS alpha) device at the level of the quadriceps muscle, volunteers will be connected to cardiac monitoring device. ECG will be monitored for the detection of electric interference or the detection of noise suggestive of dysrhythmias. Success will be based on the following criteria: (1) intervention does not induce noise of more than 0.1mV in amplitude; and (2) does not introduce signal suggestive of cardiac dysrhythmias (VT/VF/AF/PVC/PAC)

  During the 25 minutes that the EMS is applied to each test subject.

Secondary Outcomes (1)

• Grading of muscle contraction to electrical stimulation using the scale for rating the quality of muscle contractions.

  During the 25 minutes that the EMS is applied to each test subject.

Study Arms (1)

Intervention group

EXPERIMENTAL

Volunteers will receive electrical muscle stimulation.

Device: Electrical muscle stimulation

Interventions

Electrical muscle stimulation DEVICE

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).

Also known as: MyokinE100 (CL-EMS alpha)

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Age 18 to 65
• Healthy volunteers with no significant past medical history

You may not qualify if:

• 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

Sponsors & Collaborators

• Health Discovery Labs: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator
• University of Texas at Austin: collaborator
• Ascension Health: collaborator

Study Sites (1)

Ascension Texas Clinical Education Center (CEC)

Austin, Texas, 78701, United States

Location

Related Links

• ICU-acquired weakness and recovery from critical illness
• Feasibility of neuromuscular electrical stimulation in critically ill patients

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Oussama Hassan, MD

  Health Discovery Labs LLC

  STUDY DIRECTOR

• Paul Harford, MD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 5, 2023
• Study Start: August 22, 2023
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)