Electrical Stimulation for Critically Ill Post-Covid-19 Patients

NCT05198466 | Completed Phase 2 Results FDA Device

• 1 other identifier: H-47781-B
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19; Muscle Atrophy; Muscle Weakness

Keywords

Electrical Stimulation; Skin perfusion; Muscle dysfunction

Outcome Measures

Primary Outcomes (2)

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

  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).

  an average of 4 weeks (Phase II)

• Ankle Strength

  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).

  an average of 4 weeks (phase II).

Secondary Outcomes (1)

• Plantar Oxyhemoglobin

  an average of 4 weeks (phase II)

Study Arms (2)

Active E-Stim

ACTIVE COMPARATOR

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

Device: Electrical Stimulation

Electrical Stimulation - Sham

SHAM COMPARATOR

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

Device: Electrical Stimulation - Sham

Interventions

Electrical Stimulation DEVICE

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

Active E-Stim

Electrical Stimulation - Sham DEVICE

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

Electrical Stimulation - Sham

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Avazzia, Inc: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Zulbaran-Rojas A, Lee M, Bara RO, Flores-Camargo A, Spitz G, Finco MG, Bagheri AB, Modi D, Shaib F, Najafi B. Electrical stimulation to regain lower extremity muscle perfusion and endurance in patients with post-acute sequelae of SARS CoV-2: A randomized controlled trial. Physiol Rep. 2023 Mar;11(5):e15636. doi: 10.14814/phy2.15636.

  PMID: 36905161 DERIVED

MeSH Terms

Conditions

COVID-19; Muscular Atrophy; Muscle Weakness

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Results Point of Contact

• Title: Bijan Najafi
• Organization: Baylor College of Medicine

bijan.najafi@bcm.edu

7137987536

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Devices may be active or sham.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 20, 2022
• Study Start: August 18, 2021
• Primary Completion: August 18, 2022
• Study Completion: August 18, 2022
• Last Updated: March 7, 2023
• Results First Posted: January 18, 2023

Record last verified: 2023-02

Locations

US (1)