Electrical Stimulation for Critically Ill Covid-19 Patients
Condition: Covid19; Muscle Atrophy; Muscle Weakness
MeSH terms: COVID-19; Muscle Weakness; Muscular Atrophy; Asthenia
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Electrical Stimulation; Electrical Stimulation - Sham
Intervention type(s): Device; Device
Intervention description(s): 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).; 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to intervention (IG) or control group (CG) with ratio of 1:1. The entire cohort will receive daily electrical stimulation (EE) in lower extremity (e.g. Gastronemius muscle) for up to 1 hour. The EE device will be functional for IG and non-functional for CG.
Phase I will include patients (n=19) admitted to the hospital due to severe COVID-19 infection. The time frame for therapy will be 2 weeks or until hospital discharge, whichever comes first.
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: electrical stimulation; skin perfusion; Muscle dysfunction