Vagal Stimulation for POTS
Trial Summary
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 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.12345
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.678910
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.1361011
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.
Research Team
Italo Biaggioni, MD
Principal Investigator
Vanderbilt University Medical Center
Andre Diedrich, MD, PhD
Principal Investigator
Vanderbilt University Medical Center
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive vagal stimulation or placebo to assess heart rate modulation and symptom improvement during tilt study days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo
- Stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University
Lead Sponsor