Vagal Nerve Stimulation for POTS
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to test the hypothesis that an antibody-mediated autoimmune reaction will cause symptoms of autonomic dysfunction in some patients with postural tachycardia syndrome (POTS). The investigators further hypothesize that electrical stimulation of the vagus nerve will improve POTS symptoms, autoimmunity and inflammation.
Will I have to stop taking my current medications?
The trial protocol does not specify if participants with POTS need to stop their current medications. However, healthy control subjects must not be on any chronic medications during the study.
Is vagal nerve stimulation safe for humans?
Vagal nerve stimulation (VNS) is generally considered safe, but it can have side effects. Surgical implantation can lead to infections and heart rate issues, while stimulation might cause voice changes, tingling, cough, headache, and throat pain. Non-invasive VNS is safer and more tolerable, reducing the need for surgery.12345
How is vagal nerve stimulation treatment different from other treatments for POTS?
Vagal nerve stimulation (VNS) is unique because it involves using a small device to send electrical impulses to the vagus nerve, which is different from typical drug treatments. This method is already used for epilepsy and is considered low in adverse effects, offering a non-drug alternative for managing symptoms.678910
What data supports the effectiveness of this treatment?
Vagus nerve stimulation (VNS) has been used effectively as a treatment for epilepsy, helping to reduce seizure frequency in many patients, although its effectiveness can vary. This suggests that VNS may have potential benefits for other conditions like POTS, even though specific data for POTS is not provided.6891112
Who Is on the Research Team?
Stavros Stavrakis, MD
Principal Investigator
University of Oklahoma
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 with Postural Tachycardia Syndrome (POTS), characterized by a rapid heartbeat upon standing, without other causes of orthostatic tachycardia. Healthy controls must be non-smoking and not on chronic medications. Excluded are those with recent heart attacks, significant immune or blood disorders, pregnancy, pacemakers or cochlear implants, severe hypertension, history of vagotomy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either active vagal stimulation or sham stimulation for 2 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sham stimulation
- Vagal stimulation
Vagal stimulation is already approved in European Union, United States, United Kingdom for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Oklahoma
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator