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WithdrawnNCT04207476Updated Jan 26, 2026

Magnesphere for Autonomic Alteration

An interventional study of EMF and Placebo in Hart Failure With Reduced Ejection Fraction, sponsored by University of Oklahoma. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-26.

Sponsored by University of Oklahoma · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Study was never initiated due to COVID and computer difficulties.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

To evaluate the physiologic effects of an electromagnetic resonator(EMF) on autonomic nervous system tone modulation through measurement of heart rate variability(HRV).

Null Hypothesis: An EMF Resonator will not change autonomic nervous system tone and no demonstrable difference in physiological parameters will recorded.

Alternative Hypothesis: Using an EMF Resonator will enhance parasympathetic activty as supported by HRV.

Read the detailed description

During the initial encounter, participants will be randomized to either therapy or sham. The randomization scheme will be blinded to all investigators, will be devoid of patient information, and will be programmed by a non·investigator third party. All patients will receive the same total duration of therapy, and all patients will receive a sham and a treatment session.

Participants will wear head phones to reduce effects of any outside noises and will lay supine in a chair at approximately 40 degrees which is inside the FDA approved Resonator® EMF field. The active treatment session will be A160 which is a narrow range but variable magnetic field. This ranged from 3.1 x10·8 to 3.2 x 10-8 amplitude with a frequency of 0.857-0.859.

Eligible participants will arrive for testing in the morning and will be randomized to either treatment sequence. Randomization will be predetermined. Mobile phones and pagers will be placed into airplane mode during the study on a table in the room. The patient will be connected to HRV measurement systems. A BP reading will be taken in each arm. Patients will then lay supine in a standardized relaxation chair at approximately 40 degrees at which time the headphones will be placed. Ambient room light will remain powered on during therapy and will remain unchanged regardless of randomization. The researcher will then start either arm A or B (based on randomization). During the session, each participant will be given a short novel/magazine to read to reduce the chance of sleeping.

All HRV monitors will be disconnect and the subject's electronics will be returned.

02

Conditions studied

  • Hart Failure With Reduced Ejection Fraction
03

In context

Lead sponsor

University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Male and female patients more than 18 years old with LVEF of \< 40%(N=20)
  2. Healthy age matched controls (N=20)
  3. Ability to lay in a reclining chair for at least 60 minutes

Exclusion criteria

Exclusion Criteria:

  • 1. Inability to provide consent 2. Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases) 3. Recent (\<6 months) stroke or myocardial infarction 4. Severe heart failure (NYHA IV) 5. Hemodialysis 6. Recurrent vaso-vagal syncopal episodes 7. Unilateral or bilateral vagotomy 8. Pregnancy or breast feeding
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Treatment arm

    Active magnetic field exposure will be performed by use of a EMF resonator. Stimulator will be applied continuously for 1 hour.

    Device: EMF

  • Placebo comparator
    Placebo

    Placebo magnetic field exposure will be performed by use of a EMF resonator. Stimulator will be applied continuously for 1 hour.

    Device: Placebo

Interventions

  • DeviceEMF

    Active magnetic field exposure will be performed by use of a EMF resonator. Stimulator will be applied continuously for 1 hour.

  • DevicePlacebo

    No magnetic field exposure will be given while patients are assigned to this arm for a duration of 1 hour.

06

What researchers measure

Primary outcomes

  1. Heart rate variability(HRV)

    HRV will be measured using continuous 10 minute ECG pre and post exposure

    Time frame: 1 hour

07

Study locations

1 site
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73117, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04207476
Lead sponsor
University of Oklahoma
Responsible party
Sponsor
First posted
Dec 20, 2019
Start date
Jul 25, 2021
Primary completion
Oct 12, 2022
Completion
Oct 12, 2022
Last update
Jan 26, 2026

Study contacts

Tarun Dasari, MD
principal investigator · OUHSC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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