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

NCT04895267 | Unknown

• 1 other identifier: Registration number: 818
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Acute Respiratory Failure; Oxygen Deficiency

Keywords

SpO2; low-field thoracic magnetic stimulation; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• 1. Change from Baseline Peripheral Oxygen Saturation levels (SpO2) during the intervention

  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

  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 Outcomes (3)

• 1. Magnetic hyperthermia

  30 minutes

• 2. Frequency of the pulsed magnetic stimulation

  30 minutes

• 3. Magnetic flux density of the pulsed magnetic stimulation

  30 minutes

Study Arms (2)

Real Low-field thoracic magnetic stimulation (LF-ThMS)

EXPERIMENTAL

Crossover, single-blind session of low field thoracic magnetic stimulation (real LF-ThMS)

Device: Low-field thoracic magnetic stimulation (LF-ThMS)

Sham Low-field thoracic magnetic stimulation (LF-ThMS)

SHAM COMPARATOR

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)

Interventions

Low-field thoracic magnetic stimulation (LF-ThMS) DEVICE

A 30 minutes session of low-field thoracic magnetic stimulation (LF-ThMS) is planned for each participant.

Real Low-field thoracic magnetic stimulation (LF-ThMS); Sham Low-field thoracic magnetic stimulation (LF-ThMS)

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Elias Manjarrez: lead
• National Council of Science and Technology, Mexico: collaborator

Study Sites (1)

Benemérita Universidad Autónoma de Puebla

Puebla City, 72570, Mexico

Location

Related Publications (1)

• Dominguez-Nicolas SM, Manjarrez E. Low-field thoracic magnetic stimulation increases peripheral oxygen saturation levels in coronavirus disease (COVID-19) patients: A single-blind, sham-controlled, crossover study. Medicine (Baltimore). 2021 Oct 8;100(40):e27444. doi: 10.1097/MD.0000000000027444.

  PMID: 34622862 DERIVED

MeSH Terms

Conditions

COVID-19; Hypoxia

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; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elias Manjarrez, PhD

  Benemérita Universidad Autónoma de Puebla

  PRINCIPAL INVESTIGATOR

• Saul M Dominguez-Nicolas, PhD

  Universidad Veracruzana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The investigators designed a single-blind, sham-controlled, crossover study, in which the COVID-19 participants were blinded for the real LF-ThMS or sham stimulation conditions.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Profesor Investigador Titular

Model Details: Arms: The investigators designed a single-blind, sham-controlled, crossover study on COVID-19 participants who underwent two sessions of the study (real and sham Low-field thoracic magnetic stimulation, LF-ThMS), and other COVID-19 participants who underwent only the real LF-ThMS. Sham comparator: For sham exposure, the coils were positioned in the same coordinates in the same COVID-19 participants, but the LF-ThMS pulse generator was not turned on.

Study Record Dates

• First Submitted: May 15, 2021
• First Posted: May 20, 2021
• Study Start: July 3, 2020
• Primary Completion: August 3, 2022
• Study Completion: September 17, 2022
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication
• Access Criteria: open access

Locations

ME (1)