Vagal Stimulation for POTS

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

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Some patients experience high heart rates and symptoms of light-headedness, fatigue, headache during standing despite well maintained blood pressure. These patient are disabled and can't be in upright position for a longer time. The purpose of this study is to test whether electrical stimulation of a nerve through a skin of the ear may improve heart rate response and reduce disabling symptoms.

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.

Is vagal nerve stimulation generally safe for humans?

Vagal nerve stimulation (VNS) has been studied for various conditions, and while it is generally considered safe, there are rare cases of heart rhythm issues, such as bradyarrhythmias (slow heart rate) and complete heart block, reported during its use. Most studies suggest it is safe and tolerable, but individuals with certain heart conditions may be at risk. ^{1 2 3 4 5}

How does vagal stimulation treatment for POTS differ from other treatments?

Vagal stimulation for POTS is unique because it uses a non-invasive method to stimulate the vagus nerve, which may help reduce symptoms by modulating heart rate and reducing inflammation. This approach is different from traditional treatments like medications that primarily focus on managing symptoms through blood pressure and heart rate control. ^{1 5 6 7 8}

What data supports the effectiveness of vagal stimulation treatment for POTS?

The research suggests that POTS involves issues with the autonomic nervous system, including impaired vagal (related to the vagus nerve) control. Vagal stimulation, which can help regulate heart rate and improve autonomic function, might be beneficial for POTS patients by addressing these underlying autonomic dysfunctions. ^{7 8 9 10 11}

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. United States pubmed.ncbi.nlm.nih.gov

Vagal and Sympathetic Function in Neuropathic Postural Tachycardia Syndrome. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Postural orthostatic tachycardia syndrome: clinical presentation, aetiology and management. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Postural tachycardia syndrome: a heterogeneous and multifactorial disorder. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Quantitative assessment of autonomic symptom burden in Postural tachycardia syndrome (POTS). [2020]

5. China pubmed.ncbi.nlm.nih.gov

[Evaluation of the changes in heart rate during head-up test predicting the efficacy of oral rehydration salts on postural tachycardia syndrome in children]. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

[Chronic cervical vagal stimulation. Mechanisms of action and clinical relevance for heart failure]. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

The challenge of magnetic vagal nerve stimulation for myocardial infarction -preliminary clinical trial. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Vagal stimulation for heart diseases: from animals to men. An example of translational cardiology. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Complete heart block with ventricular asystole during left vagus nerve stimulation for epilepsy. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Intermittent left cervical vagal nerve stimulation damages the stellate ganglia and reduces the ventricular rate during sustained atrial fibrillation in ambulatory dogs. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Transdermal auricular vagus stimulation for the treatment of postural tachycardia syndrome. [2022]