AzTrials
AzTrials

COVID-19NCT04895267

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

A study testing Low-field thoracic magnetic stimulation (LF-ThMS) in people with COVID-19 and Acute Respiratory Failure, run by Elias Manjarrez at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 20 to 85 years
What is being tested?
Low-field thoracic magnetic stimulation (LF-ThMS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
1 siteMexico
Study dates
3 Jul 2020to 17 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Benemérita Universidad Autónoma de Puebla

    Puebla City, 72570

Other trials in Mexico

About this study

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

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.

Read the 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.

Being tested
Low-field thoracic magnetic stimulation (LF-ThMS)
Keywords
SpO2, low-field thoracic magnetic stimulation, SARS-CoV-2
Medical subject headings
COVID-19, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04895267
Study groupRoleWhat they receive
Real Low-field thoracic magnetic stimulation (LF-ThMS)ExperimentalCrossover, single-blind session of low field thoracic magnetic stimulation (real LF-ThMS)
Receives: Device: Low-field thoracic magnetic stimulation (LF-ThMS)
Sham Low-field thoracic magnetic stimulation (LF-ThMS)Sham comparatorIn 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.
Receives: Device: Low-field thoracic magnetic stimulation (LF-ThMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 minutes

  2. 2. Peripheral Oxygen Saturation levels (SpO2) after the intervention

    1. 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.

    Measured: 6 months

Secondary outcomes (3)

  1. 1. Magnetic hyperthermia

    Coils temperature on the dorsal thorax is measured every 5 minutes during a 30 minutes LF-ThMS session (sham and real).

    Measured: 30 minutes

  2. 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).

    Measured: 30 minutes

  3. 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).

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2021
  2. Study start3 Jul 2020
  3. Primary completion3 Aug 2022 (estimated)
  4. Study completion17 Sep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Crossover
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.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
17 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04895267
Sponsor's protocol ID
Registration number: 818
Status last verified
Mar 2022
First submitted
15 May 2021
Last updated
16 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The investigators (Saul M. Dominguez-Nicolas and Elias Manjarrez) plan to make individual participant data (IPD) collected in this study.

Publications

  • 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.

    PubMed 34622862

Questions about this trial

What is this clinical trial studying?

A study testing Low-field thoracic magnetic stimulation (LF-ThMS) in people with COVID-19 and Acute Respiratory Failure, run by Elias Manjarrez at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1. Change from Baseline Peripheral Oxygen Saturation levels (SpO2) during the intervention (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04895267, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in