This study aimed to present a proof-of-concept that a 30 minutes single-session oflow-field thoracic magnetic stimulation (LF-ThMS) on the dorsal thorax can be employed toincrease oxygen saturation (SpO2) levels in coronavirus disease (COVID-19) participantssignificantly. The investigators (Saul M. Dominguez-Nicolas and Elias Manjarrez)hypothesized that the variables associated with LF-ThMS, as hyperthermia, frequency, andmagnetic flux density in the dorsal thorax, might be correlated to SpO2 levels in theseparticipants. The investigators designed a single-blind, sham-controlled, crossover studyon 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.
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.
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.
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
Benemérita Universidad Autónoma de Puebla
Puebla, Mexico