Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04895267
Other study ID # Registration number: 818
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Withdrawn NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure