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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04895267
• Other study ID #: Registration number: 818
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 3, 2020
• Est. completion date: September 17, 2022

Study information

• Verified date: March 2022
• Source: Hospital Univeristario Benemerita Universidad Autonoma de Puebla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. completion date: September 17, 2022
• Est. primary completion date: August 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• COVID-19
• Hypoxia
• Oxygen Deficiency
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Mexico	Benemérita Universidad Autónoma de Puebla	Puebla

Sponsors (2)

Lead Sponsor	Collaborator
Elias Manjarrez	National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	1. Magnetic hyperthermia	Coils temperature on the dorsal thorax is measured every 5 minutes during a 30 minutes LF-ThMS session (sham and real).	30 minutes
Secondary	2. Frequency of the pulsed magnetic stimulation	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
Secondary	3. Magnetic flux density of the pulsed magnetic stimulation	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