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NCT Number: NCT04685213

Electrical Stimulation for Critically Ill Covid-19 Patients

Unfortunately, hospital-acquired weakness is highly prevalent among COVID-19 hospitalized patients, who often require prolonged bed-rest or paralytics for an extended period of time in order to maintain oxygenation. Prolonged bed rest has been associated with pronounced loss of muscle mass that can exceed 10% over the 1st week, which leads to functional impairment and complications post-hospital discharge. Physical therapy and in-hospital mobility program may reduce the incident of hospital-acquired weakness, but they are often impractical for COVID-19 patients. In particular, conventional mobility programs are challenging for those who are being treated in an intensive Care Unit. The purpose of this study is to test feasibility and proof-of-concept effectiveness of daily use of lower extremity electrical stimulation (EE) therapy, as a practical solution to address lower extremity muscle deconditioning, to address chronic consequences of COVID-19 including hospital-acquired weakness.

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Key information

Conditions

Covid19 Atrophy COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Muscle Atrophy Muscle Weakness Muscular Atrophy Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nidovirales Infections Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

Phase I:

The purpose of this study is to test feasibility and proof-of-concept effectiveness of lower extremity electrical stimulation (EE) therapy to prevent muscular complications of COVID-19 including hospital-acquired weakness and neuropathy. This is a proof of concept randomized control trial (RCT) study for prevention. Eligible participants (n=19 anticipated) will be recruited from the Baylor St. Luke's' Medical Center (Houston, Texas). To be eligible participants should be hospitalized because of COVID-19 infection and suspected to be at risk for hospital acquired-weakness based on judgment of clinical intensivist investigators. Participants will be excluded if they are paralyzed. Other exclusion criteria include blow the knee amputation, those who have a demand-type cardiac pacemaker, implanted defibrillator or other implanted electronic device; those with wound infection, and other conditions that may interfere with outcomes or increase the risk of the use EE based on judgement of clinicians.

The Investigators hypothesize that implementation of EE as means of regular activation of lower extremity muscle is feasible and acceptable for the target population and would help to retain lower extremity muscle mass, lower extremity tissue oxygen saturation and perfusion, and thus reducing the severity of hospital acquired weakness and potentially improve outcomes of treatment among COVID-19 patients.

Participants will be randomized to intervention (IG) or control group (CG)). The entire cohort will receive daily EE in lower extremity (e.g. Gastronemius, tibial anterior muscle) up to 1 hour. EE therapy will be provided using a bio-electric stimulation technology (BEST) platform (Tennant Biomodulator PRO®, AVAZZIA, Inc.). The EE device will be functional for IG and non-functional for CG. The primary outcomes include between group difference and change from the baseline in muscle endurance, muscle strength, lower extremity tissue oxygen saturation, neuropathy, and muscle atrophy. Outcomes will be assessed at baseline, time of discharge or 2 weeks, whichever comes first.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COVID-19 test positive critically ill patients in need of assisted ventilation requiring care in the intensive care unit
  • COVID-19 test positive critically ill patients in need of assisted ventilation requiring prolonged care in the hospital

Exclusion criteria

  • Paralyzed patients (i.e., rocuronium, cisatracurium) at the moment of enrollment
  • Patients under vasopressor therapy (i.e., norepinephrine, epinephrine, vasopressin) at the moment of enrollment
  • Patients expected to be discharged in the next 24 hours
  • Patient has a demand-type cardiac pacemaker, implanted defibrillator or other implanted electronic device.
  • Active wound infection
  • Below the knee amputations
  • Based on the clinicians decision whether the patient is eligible for the study

Treatment and study plan

Electrical Stimulation

Device

Subjects will receive an active electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).

Electrical Stimulation - Sham

Device

Subjects will receive a sham electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).

Primary outcomes

  1. Change in Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation

    Time frame: an average of 2 weeks (Phase I)

    Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).

  2. Change in Ankle Strength

    Time frame: an average of 2 weeks (Phase I)

    Ankle strength will be measured in response to the average of three 5-second dorsiflexion maximum voluntary isometric contractions per 30 seconds of relaxation in-between using a dynamometer (RoMech Digital Hanging Scale).

Secondary outcomes

  1. Change in Plantar Tissue Oxygen Saturation/Consumption

    Time frame: an average of 2 weeks (Phase I)

    Percentage of tissue oxygen saturation (SatO2) will be measured using a validated near-infrared (NIR) camera (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Can) that detects an approximate value of real-time SatO2 level in superficial tissue. The metatarsus area including the five toes will be traced.

Other outcomes

  1. Likelihood of Falling

    Time frame: an average of 2 weeks (Phase I)

    Assessment via the total score of Morse Fall Scale, which is the sum of six variables' score depending on presence or absence of:

    • History of falling: Score 25 for falls during the present hospital admission or immediate history of physiological falls; if not, score 0.
    • Secondary diagnosis: 15 if there is more than one medical diagnosis; if not, score 0.
    • Ambulatory aids: 0 for walking without a walking aid, uses wheelchair, or is on bedrest; 15 for use of crutches, a cane, or a walker; 30 for ambulation clutching onto the furniture for support.
    • Intravenous therapy: 20 for intravenous apparatus or a heparin lock inserted; if not, score 0.
    • Gait: 0 if has a normal gait; 10 weak gait; 20 impaired gait.
    • Mental status: patient's own self-assessment; 0 if normal; 15 if impaired.

    Scale:

    Minimum score or low risk: < 24 points Medium score or Moderate risk: 25-45 points Maximum score or high risk: > 45 points.

  2. Change in Gastrocnemius Muscle Strength

    Time frame: An average of 2 weeks (Phase I)

    Gastrocnemius Muscle Strength will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Avazzia, Inc

Registry information

Official study title

Electrical Stimulation Therapy for Preventing Hospital-acquired Weakness in Critically Ill COVID-19 Patients - A Proof of Concept Randomized Controlled Trial

Acronym: Phase I

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 28, 2020
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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