Skip to main content
OpenTrials
Completed

NCT Number: NCT05198466

Electrical Stimulation for Critically Ill Post-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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Atrophy 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 2

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Post-COVID-19 patients who required hospitalization due to COVID-19 severe infection.
  • Post-COVID-19 patients who required hospitalization and present neuromuscular sequelae due to COVID-19 severe infection.

Exclusion criteria

  • 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 for 4 weeks (phase II).

Electrical Stimulation - Sham

Device

Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).

Primary outcomes

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

    Time frame: an average of 4 weeks (Phase II)

    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. Ankle Strength

    Time frame: an average of 4 weeks (phase II).

    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. Plantar Oxyhemoglobin

    Time frame: an average of 4 weeks (phase II)

    Percentage of oxyhemoglobin (OxyHb) 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 OxyHb level in superficial tissue. The metatarsus area including the five toes will be traced. Data reported includes plantar oxyhemoglobin after 10 minutes of stopping 1 hour of electrical stimulation therapy.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Avazzia, Inc

Registry information

Official study title

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

Acronym: Phase II

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2022
Registry last updated
Mar 7, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.