Clinical trial NCT04895267: Low-field Thoracic Magnetic Stimulation Increases Peripheral Oxygen Saturation Levels in COVID-19 Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Acute Respiratory Failure
Oxygen Deficiency
Keywords: SpO2
low-field thoracic magnetic stimulation
SARS-CoV-2
Lead sponsor: Hospital Univeristario Benemerita Universidad Autonoma de Puebla
Sponsor class: OTHER
Collaborators: name: National Council of Science and Technology, Mexico
First posted: 2021-05-20
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1. Change from Baseline Peripheral Oxygen Saturation levels (SpO2) during the intervention
timeFrame: 30 minutes
measure: 2. Peripheral Oxygen Saturation levels (SpO2) after the intervention
timeFrame: 6 months
Secondary outcomes:
measure: 1. Magnetic hyperthermia
timeFrame: 30 minutes
measure: 2. Frequency of the pulsed magnetic stimulation
timeFrame: 30 minutes
measure: 3. Magnetic flux density of the pulsed magnetic stimulation
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Puebla
country: Mexico
facility: Benemérita Universidad Autónoma de Puebla
Study officials:
affiliation: Benemérita Universidad Autónoma de Puebla
name: Elias Manjarrez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Veracruzana
name: Saul M Dominguez-Nicolas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.