Active TENS Stimulation for Atrial Fibrillation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Atrial Fibrillation+1 More
Transcutaneous Electrical Nerve Stimulation Device - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will study whether a new device, called tVNS, can help treat AF by investigating its effects on the autonomic nervous system, the atrial substrate, and neuromodulators.

Eligible Conditions
  • Atrial Fibrillation
  • Paroxysmal atrial fibrillation

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 6 months

6 months
Effects of tVNS on Atrial fibrillation burden
Effects of tVNS on Autonomic Tone
Effects of tVNS on P wave alternans
Effects of tVNS on neuropeptide Y

Trial Safety

Trial Design

2 Treatment Groups

Active TENS Stimulation
1 of 2
Inactive TENS Stimulation
1 of 2
Active Control
Non-Treatment Group

160 Total Participants · 2 Treatment Groups

Primary Treatment: Active TENS Stimulation · Has Placebo Group · N/A

Active TENS Stimulation
Device
ActiveComparator Group · 1 Intervention: Transcutaneous Electrical Nerve Stimulation Device · Intervention Types: Device
Inactive TENS Stimulation
Device
ShamComparator Group · 1 Intervention: Transcutaneous Electrical Nerve Stimulation Device · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

University of OklahomaLead Sponsor
419 Previous Clinical Trials
96,910 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
1,968 Patients Enrolled for Atrial Fibrillation

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: October 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.