Vagal Stimulation for POTS

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University

Must not be taking: Heart rate medications

Disqualifiers: Cancer, Heart disease, Pregnancy, others

Compensation: Varies

Number of Visits: 2

Duration: 2 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether stimulating a nerve in the ear can help individuals with POTS, a condition where standing causes a rapid heart rate and symptoms like dizziness and fatigue. Participants will receive either real or placebo (fake) stimulation to determine its effectiveness in managing these symptoms. The study seeks individuals who have experienced these symptoms for at least six months and have a rapid heart rate upon standing. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could lead to new treatment options for POTS.

Will I have to stop taking my current medications?

Yes, you will need to stop taking medications that affect heart rate, blood pressure, and hormone levels that regulate blood pressure.

What prior data suggests that this vagal stimulation technique is safe for patients with POTS?

Research has shown that stimulating the vagus nerve is generally safe. Studies have found that transcutaneous vagus nerve stimulation (tVNS) is well-tolerated and lacks major side effects, unlike some medications. In trials with individuals who have postural orthostatic tachycardia syndrome (POTS), tVNS showed promising results by helping to lower high heart rates when standing.

Whether used for short or long periods, tVNS did not cause significant negative effects, suggesting it is a safe option for managing symptoms like dizziness and fatigue associated with POTS. While more research is needed, current evidence supports the safety of this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Postural Orthostatic Tachycardia Syndrome (POTS) involve medications like beta-blockers, fludrocortisone, and midodrine, which primarily focus on managing symptoms such as heart rate and blood pressure. However, vagal stimulation is unique because it targets the nervous system directly, aiming to improve heart rate modulation by stimulating the vagus nerve. Researchers are excited about this approach because it offers a non-drug alternative that could potentially provide relief from symptoms without the side effects commonly associated with medications. Additionally, the use of a sham intervention (placebo) helps ensure that any observed benefits are truly due to the stimulation itself, increasing confidence in its effectiveness.

What evidence suggests that vagal stimulation is effective for POTS?

In this trial, participants will receive either vagal stimulation or a placebo treatment to assess its effects on Postural Orthostatic Tachycardia Syndrome (POTS). Research has shown that stimulating a nerve in the ear with small electrical signals can alleviate POTS symptoms. In earlier studies, patients who received this stimulation had a slower heart rate when standing compared to those who did not. A two-week treatment improved heart rate control and reduced symptoms like dizziness and tiredness. Overall, this stimulation appears to help balance the nervous system, potentially lessening the uncomfortable symptoms experienced when standing. ^{1 2 3 4 6}

Who Is on the Research Team?

Italo Biaggioni, MD

Principal Investigator

Vanderbilt University Medical Center

Andre Diedrich, MD, PhD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with Postural Orthostatic Tachycardia Syndrome (POTS), who experience rapid heartbeat and symptoms like light-headedness when standing. Participants must be able to stop taking certain medications, not smoke, and have had POTS symptoms for at least 6 months. Pregnant individuals or those with major medical conditions like cancer or heart disease cannot join.

Inclusion Criteria

I can safely stop taking my heart rate, blood pressure, and certain hormone medications.

I have had symptoms when standing up for at least 6 months.

I have been diagnosed with idiopathic postural tachycardia syndrome and I do not smoke.

Exclusion Criteria

I do not have major medical issues like cancer or heart disease.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vagal stimulation or placebo to assess heart rate modulation and symptom improvement during tilt study days

2 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Stimulation

Trial Overview

The study is testing if electrical stimulation of a nerve in the ear can help control heart rate and reduce symptoms associated with POTS. Participants will either receive this nerve stimulation or a placebo treatment without any active effects to compare results.

How Is the Trial Designed?

Group I: Vagal Stimulation First Active Control 2 Interventions

Vagal stimulation to improve upright heart rate modulation and symptoms is given on first tilt study day. Placebo stimulation with ineffective low amplitude and frequency (sham intervention) is given on second tilt study.

Group II: Placebo First Placebo Group 2 Interventions

Placebo stimulation with ineffective low amplitude and frequency (sham intervention) is given on first tilt study day. Vagal stimulation to improve upright heart rate modulation and symptoms is given on second tilt study day.

Who Is Running the Clinical Trial?

Vanderbilt University

Lead Sponsor

Trials

714

Recruited

6,143,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10762669/

Non-invasive Vagus Nerve Simulation in Postural Orthostatic ...

Preliminary clinical data suggest that tVNS decreased postural tachycardia in patients with POTS compared with sham stimulation. Further ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0953620525004078

Short and long term effects of a two-week transcutaneous ...

Fourteen-day tVNS enhanced cardiovagal modulation, reduced sympathetic activity, and improved orthostatic symptoms in Hyper-POTS patients.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03930914

Vagus Nerve Stimulation in Treatment of Postural ...

It is anticipated that results will provide a potential therapeutic approach based on the understanding of POTS. Official Title. Vagus Nerve Stimulation in ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37999672/

Noninvasive Vagus Nerve Stimulation in Postural Tachycardia ...

Preliminary studies show that transcutaneous vagus nerve stimulation (tVNS) is beneficial in animal models of postural tachycardia syndrome (POTS).

5.

seizure-journal.com

seizure-journal.com/article/S1059-1311(18)30011-6/fulltext

Vagal nerve stimulation is beneficial in postural orthostatic ...

HUTT done at one month and three months after implantation was normal. VNS was gradually increased to 1 mA, which led to significant reduction in seizure rate ...

6.

autonomicneuroscience.com

autonomicneuroscience.com/article/S1566-0702(21)00116-8/abstract

Transdermal auricular vagus stimulation for the treatment ...

This article will address crucial methodological aspects of tVNS and provide preliminary results of its acute and chronic use in POTS, with ...