Electrical Stimulation for Critically Ill Post-Covid-19 Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-18

Study Completion Date

2022-08-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Electrical Stimulation for Critically Ill Covid-19 Patients

NCT04685213

Covid19 Muscle Atrophy Muscle Weakness

COMPLETED PHASE1

Effect of Electrical Muscle Stimulation in Critically Ill Patients

NCT01637467

Critical Illness

COMPLETED PHASE1/PHASE2

Neuromuscular Electrical Stimulation in Critically Ill Patients.

NCT03815994

Critical Care Rehabilitation

SUSPENDED NA

Neuromuscular Electrical Stimulation in Mechanically Ventilated Patients

NCT05465291

Neuromuscular Electrical Stimulation ICU Acquired Muscle Weakness

COMPLETED NA

Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness

NCT00709124

Intensive Care Unit Muscle Weakness

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 Muscle Atrophy Muscle Weakness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Devices may be active or sham.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active E-Stim

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

Group Type ACTIVE_COMPARATOR

Electrical Stimulation

Intervention Type DEVICE

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

Electrical Stimulation - Sham

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

Group Type SHAM_COMPARATOR

Electrical Stimulation - Sham

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.