Electrical Stimulation for Critically Ill Post-Covid-19 Patients
Condition: COVID-19; Muscle Atrophy; Muscle Weakness
MeSH terms: COVID-19; Muscle Weakness; Muscular Atrophy; Asthenia
Study type: Interventional
Phase: Phase 2

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: 
      20 subjects that were hospitalized due to severe COVID-19 infection and present neuromuscular
      complications (i.e., hospital acquired weakness due to neuromyopathy) will be recruited after
      the first phase of this study is completed. Unlike Phase I (study for prevention), this is a
      proof of concept randomized control trial (RCT) study for recovery. The patients will be
      recruited from the COVID-19 Clinic at Baylor College of Medicine and will begin the study
      after being diagnosed with neuromyopathy due to prolonged hospitalization for COVID-19. This
      will be performed by a critical care and pulmonary specialist at the BCM COVID-19 Clinic. The
      entire cohort will receive daily electrical stimulation in lower extremity (e.g.
      Gastrocnemius, tibial anterior muscle) up to 1 hour to recover from Neuromyopathy
      complications and prolonged hospital stay. Participants will be randomized to intervention
      (IG) or control group (CG)). 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. In addition to taking the device home to deliver
      electrical stimulation themselves, the patients will attend a weekly assessment at the McNair
      Campus for up to 4 weeks. 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.
    

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 for 4 weeks (phase II).; Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
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. Gastrocnemius muscle) for up to 1 hour. The EE device will be functional for IG and non-functional for CG.
Phase II will include previously hospitalized patients (n=20) who had recover from severe COVID-19 infection, but present persistent neuromuscular sequelae. This will be performed in an outpatient clinic. The time frame will be 4 weeks.
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Electrical Stimulation; Skin perfusion; Muscle dysfunction