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Low-Level EMF Stimulation for Paroxysmal Atrial Fibrillation

NCT03593486 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-12-20

No results posted yet for this study

Summary

This research has two main specific aims. First, a commercially-available stimulator will be utilized to assess the effect of low-level electromagnetic field (EMF) stimulation on atrial fibrillation (AF) inducibility in patients with paroxysmal AF presenting for catheter ablation as compared to sham stimulation. We hypothesize a reduction in AF inducibility in patients treated with EMF stimulation. Second, we aim to assess for the effect of low-level EMF on level of systemic inflammatory mediators. We hypothesize a reduction in the level of the inflammatory mediator tissue necrosis factor (TNF)-α in patients treated with EMF stimulation as compared to sham stimulation. The long-term objective of this research is to develop low-level EMF as a therapeutic alternative for patients with AF, and this research will help to determine the efficacy of low-level pulsed EMF in this regard.

Conditions

Interventions

DEVICE

Low-level Pulsed EMF

Low-level pulsed electromagnetic field stimulator delivered through a Helmholtz coil positioned around the participant's head and neck. Stimulation parameters are 0.032 µG at 0.89 Hz for 60 minutes.

DEVICE

Sham Stimulation

The stimulator will be placed around the participant's head and neck, but no EMF will be delivered.

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Sunny Po, MD, PhD · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-27
Primary Completion
2019-11-26
Completion
2019-11-26

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03593486 on ClinicalTrials.gov