Magnesphere for Autonomic Alteration

NCT ID: NCT04207476

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-25
• Study Completion Date: 2022-10-12

Brief 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.

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.

Conditions

Hart Failure With Reduced Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment arm

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

Group Type: EXPERIMENTAL

EMF

Intervention Type: DEVICE

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

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

Interventions

EMF

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

Intervention Type: DEVICE

Placebo

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

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tarun Dasari, MD

Role: PRINCIPAL_INVESTIGATOR

OUHSC

Locations

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

11415

Identifier Type: -

Identifier Source: org_study_id