18 Participants Needed

Vagal Stimulation for POTS

Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University

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.12345

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.15678

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.7891011

Who Is on the Research Team?

Italo Biaggioni

Italo Biaggioni, MD

Principal Investigator

Vanderbilt University Medical Center

Andre Diedrich | Bio | University ...

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.
See 1 more

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?
2Treatment groups
Active Control
Placebo Group
Group I: Vagal Stimulation FirstActive Control2 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 FirstPlacebo Group2 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University

Lead Sponsor

Trials
714
Recruited
6,143,000+

Citations

Vagal and Sympathetic Function in Neuropathic Postural Tachycardia Syndrome. [2020]
Postural orthostatic tachycardia syndrome: clinical presentation, aetiology and management. [2020]
Postural tachycardia syndrome: a heterogeneous and multifactorial disorder. [2023]
Quantitative assessment of autonomic symptom burden in Postural tachycardia syndrome (POTS). [2020]
[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]
[Chronic cervical vagal stimulation. Mechanisms of action and clinical relevance for heart failure]. [2018]
The challenge of magnetic vagal nerve stimulation for myocardial infarction -preliminary clinical trial. [2020]
Vagal stimulation for heart diseases: from animals to men. An example of translational cardiology. [2021]
Complete heart block with ventricular asystole during left vagus nerve stimulation for epilepsy. [2022]
10.United Statespubmed.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]
Transdermal auricular vagus stimulation for the treatment of postural tachycardia syndrome. [2022]
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