Low-field Thoracic Magnetic Stimulation Increases Peripheral Oxygen Saturation Levels in COVID-19 Patients

March 14, 2022 updated by: Elias Manjarrez

Low-field Thoracic Magnetic Stimulation Increases Peripheral Oxygen Saturation Levels in Coronavirus Disease (COVID-19) Patients: a Single-blind, Sham-controlled, Crossover Study

This study aimed to present a proof-of-concept that a 30 minutes single-session of low-field thoracic magnetic stimulation (LF-ThMS) on the dorsal thorax can be employed to increase oxygen saturation (SpO2) levels in coronavirus disease (COVID-19) participants significantly. The investigators (Saul M. Dominguez-Nicolas and Elias Manjarrez) hypothesized that the variables associated with LF-ThMS, as hyperthermia, frequency, and magnetic flux density in the dorsal thorax, might be correlated to SpO2 levels in these participants. The investigators designed a single-blind, sham-controlled, crossover study on COVID-19 participants who underwent two sessions of the study (real and sham LF-ThMS), and other COVID-19 participants who underwent only the real LF-ThMS.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The severe acute respiratory syndrome coronavirus (CoV)-2 (SARS-CoV-2) may cause low SpO2 and respiratory failure in COVID-19 patients. Hence the increase of SpO2 levels could be crucial for the quality of life and recovery of these patients. In this clinical trial, the investigators (Saul M. Dominguez-Nicolas and Elias Manjarrez) propose that an electromagnetic device termed low-field thoracic magnetic stimulation (LF-ThMS) system could be employed for 30 minutes to increase SpO2 levels in COVID-19 participants. This device non-invasively delivers a pulsed magnetic field from 100 to 118 Hz and 10.5 to 13.1 milliTesla (mT) (i.e., 105 to 131 Gauss) to the dorsal thorax. In line with preliminary studies, the scientific literature, and other devices currently used in musculoskeletal magnetic therapy, these frequencies and magnetic flux densities are safe for the participants. The investigators designed a single-blind, sham-controlled, crossover study on COVID-19 participants who underwent two sessions of the study (real and sham LF-ThMS) and other participants who underwent only the real LF-ThMS. The study design includes a 30 minutes single-session of LF-ThMS to avoid confounding factors related to the spontaneous recovery by natural immunity, common in many COVID-19 patients several days after the contagion. Here the LF-ThMS protocol is not intended to demonstrate its use as therapy but is instead designed to examine the following physiological hypothesis. The hypothesis that there is a statistically significant correlation between magnetic flux density, frequency, or temperature associated with the real LF-ThMS and SpO2 levels in COVID-19 participants. In this context, the present clinical trial is relevant because it could motivate future randomized clinical trials to examine whether the LF-ThMS could be helpful as a potential therapy.

Study Type

Interventional

Enrollment (Anticipated)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Puebla, Mexico, 72570
        • Benemérita Universidad Autónoma de Puebla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult participants diagnosed with mild to moderate COVID-19 disease without pneumonia.
  • COVID-19 participants with a SpO2 level less or equal to 90 %, exhibiting difficulty breathing, but not intubated.
  • COVID-19 participants with similar pharmacological treatment against COVID-19.
  • 20-85 years old

Exclusion Criteria:

  • COVID-19 patients with acute respiratory failure requiring urgent intubation
  • COVID-19 patients with impaired consciousness
  • Pregnant woman
  • Patients with metallic implants in the thorax, abdomen, or arms, or with electronic medical devices such as pacemakers
  • Children

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real Low-field thoracic magnetic stimulation (LF-ThMS)
Crossover, single-blind session of low field thoracic magnetic stimulation (real LF-ThMS)
Device: Low-field thoracic magnetic stimulation (LF-ThMS)
A 30 minutes session of low-field thoracic magnetic stimulation (LF-ThMS) is planned for each participant.
Sham Comparator: Sham Low-field thoracic magnetic stimulation (LF-ThMS)
In the same patients the coils are positioned in the same coordinates for sham exposure, but the pulse generator is not turned on. Subjects are blinded for the real LF-ThMS or sham stimulation conditions.
Device: Low-field thoracic magnetic stimulation (LF-ThMS)
A 30 minutes session of low-field thoracic magnetic stimulation (LF-ThMS) is planned for each participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Change from Baseline Peripheral Oxygen Saturation levels (SpO2) during the intervention
Time Frame: 30 minutes
1. Change from Baseline Peripheral Oxygen Saturation levels (SpO2) at 30 minutes of LF-ThMS intervention.
30 minutes
2. Peripheral Oxygen Saturation levels (SpO2) after the intervention
Time Frame: 6 months
2. To evaluate the safety of the intervention, SpO2 levels also are evaluated up to 6 months after the 30 minutes single session of LF-ThMS intervention.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Magnetic hyperthermia
Time Frame: 30 minutes
Coils temperature on the dorsal thorax is measured every 5 minutes during a 30 minutes LF-ThMS session (sham and real).
30 minutes
2. Frequency of the pulsed magnetic stimulation
Time Frame: 30 minutes
The frequency of the pulsed LF-ThMS on the dorsal thorax is measured every 5 minutes during a 30 minutes LF-ThMS session (sham and real).
30 minutes
3. Magnetic flux density of the pulsed magnetic stimulation
Time Frame: 30 minutes
The magnetic flux density of the pulsed LF-ThMS on the dorsal thorax is measured every 5 minutes during a 30 minutes LF-ThMS session (sham and real).
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elias Manjarrez

Collaborators

National Council of Science and Technology, Mexico

Investigators

  • Principal Investigator: Elias Manjarrez, PhD, Benemérita Universidad Autónoma de Puebla
  • Principal Investigator: Saul M Dominguez-Nicolas, PhD, Universidad Veracruzana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2020

Primary Completion (Anticipated)

August 3, 2022

Study Completion (Anticipated)

September 17, 2022

Study Registration Dates

First Submitted

May 15, 2021

First Submitted That Met QC Criteria

May 15, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Registration number: 818

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators (Saul M. Dominguez-Nicolas and Elias Manjarrez) plan to make individual participant data (IPD) collected in this study.

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Access Criteria

open access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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