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Neuromodulation Device

tVNS Device for Atrial Fibrillation

N/A
Recruiting
Led By Stavros Stavrakis, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Paroxysmal atrial fibrillation
Paroxysmal atrial fibrillation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

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.

Who is the study for?
This trial is for individuals with paroxysmal atrial fibrillation, which means their heart occasionally beats irregularly. It's not for those with significant heart valve issues, severe kidney disease on dialysis, pregnant women, certain types of heart block without a pacemaker, history of vagotomy or frequent fainting spells due to vasovagal syncope, very weak hearts (ejection fraction <40%), or recent stroke or serious heart events.Check my eligibility
What is being tested?
The study tests if tVNS—a non-invasive nerve stimulation—can improve the condition and reduce episodes over six months compared to fake (sham) treatment. Researchers will also look for physical and biochemical signs that show who benefits most from this therapy.See study design
What are the potential side effects?
While specific side effects are not listed here, transcutaneous electrical nerve stimulation devices like tVNS can sometimes cause skin irritation where they're applied and may lead to discomfort or tingling sensations during use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have episodes of irregular heartbeat.
Select...
I have episodes of irregular heartbeat.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effects of tVNS on Atrial fibrillation burden
Secondary outcome measures
Effects of tVNS on Autonomic Tone
Effects of tVNS on P wave alternans
Effects of tVNS on neuropeptide Y

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active TENS StimulationActive Control1 Intervention
Group II: Inactive TENS StimulationPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,450 Total Patients Enrolled
13 Trials studying Atrial Fibrillation
2,518 Patients Enrolled for Atrial Fibrillation
Stavros Stavrakis, MDPrincipal InvestigatorUniversity of Oklahoma
5 Previous Clinical Trials
218 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
133 Patients Enrolled for Atrial Fibrillation

Media Library

Transcutaneous Electrical Nerve Stimulation Device (Neuromodulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT05172765 — N/A
Atrial Fibrillation Research Study Groups: Inactive TENS Stimulation, Active TENS Stimulation
Atrial Fibrillation Clinical Trial 2023: Transcutaneous Electrical Nerve Stimulation Device Highlights & Side Effects. Trial Name: NCT05172765 — N/A
Transcutaneous Electrical Nerve Stimulation Device (Neuromodulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05172765 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still room for participants in this research?

"The clinical trial, which was originally posted to the public on September 14th 2022 and amended October 31st of that year, is actively seeking participants."

Answered by AI

Do I qualify for enrollment in this experiment?

"This clinical trial is accepting 160 individuals who have been diagnosed with atrial fibrillation and are between 21 to 90 years old."

Answered by AI

To what extent is the participation in this trial being facilitated?

"Affirmative. Data found on clinicaltrials.gov confirms that this study, initially posted on September 14th 2022, is currently recruiting patients. Altogether 160 individuals must be enrolled from one medical center."

Answered by AI

Does this trial have a minimum age requirement, and if so, is it possible for those over 85 to participate?

"This clinical trial is accessible to those between the ages of 21 and 90, while 11 studies are available for participants below 18 years old and 474 study options can be found for seniors over 65."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What site did they apply to?
University of Oklahoma Health Sciences Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. University of Oklahoma Health Sciences Center: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)
2022. "Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05172765.
~78 spots leftby Oct 2025
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