Vagal Nerve Stimulation for POTS
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Oklahoma
Must not be taking: Chronic medications
Disqualifiers: Hypertension, Cardiovascular disease, Pregnancy, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
678910How 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.
1231112Eligibility Criteria
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
I understand and can follow the study's procedures and rules.
I either do not have health issues or have POTS with specific heart rate and blood pressure changes.
I am between 18 and 80 years old.
+1 more
Exclusion Criteria
Patients with active implants (such as a cardiac pacemaker, or a cochlear implant)
My blood pressure is higher than 150/100 mmHg.
I am currently pregnant or planning to become pregnant within the next 3 months.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either active vagal stimulation or sham stimulation for 2 months
8 weeks
Daily sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study aims to see if stimulating the vagus nerve can improve symptoms in POTS patients by potentially reducing autoimmune reactions and inflammation. Participants will receive either actual vagal stimulation or sham (fake) stimulation to compare effects.
2Treatment groups
Active Control
Placebo Group
Group I: Vagal stimulationActive Control1 Intervention
Vagal stimulation will be given at 20 Hz for 1 hour daily with the bipolar electrode attached to the tragus for 2 months.
Group II: Sham stimulationPlacebo Group1 Intervention
Sham stimulation will be given at 20 Hz for 1 hour daily with the bipolar electrode attached to the earlobe for 2 months.
Vagal stimulation is already approved in European Union, United States, United Kingdom for the following indications:
🇪🇺 Approved in European Union as Vagus nerve stimulation for:
- Epilepsy
- Depression
- Cluster headaches
🇺🇸 Approved in United States as Vagus nerve stimulation for:
- Epilepsy
- Treatment-resistant depression
- Stroke rehabilitation
🇬🇧 Approved in United Kingdom as Vagus nerve stimulation for:
- Epilepsy
- Depression
- Cluster headaches
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Oklahoma Clinical and Translational Science InstituteOklahoma City, OK
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Who Is Running the Clinical Trial?
University of OklahomaLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Repeated assessment of larynx compound muscle action potentials using a self-sizing cuff electrode around the vagus nerve in experimental rats. [2011]Vagus nerve stimulation (VNS) is an adjunctive treatment for patients with refractory epilepsy. In more than 30% of the patients VNS has no therapeutic effect. The goal of this study was to find an objective parameter that can be used as an indicator of effective stimulation of the vagus nerve.
Vagus nerve stimulation for refractory epilepsy: a Belgian multicenter study. [2007]Vagus nerve stimulation (VNS) is a symptomatic add-on treatment for patients with medically refractory epilepsy. It consists of continuous electrical stimulation of the left vagus nerve by means of a helical electrode and an implantable, programmable pulse generator. Currently, over 50,000 patients are treated with VNS worldwide.
[Vagus nerve stimulation therapy in epilepsy patients: long-term outcome and adverse effects: a retrospective analysis]. [2022]Vagus nerve stimulation (VNS) is one of the numerous stimulation procedures used in the treatment of neurological diseases in which there has been growing interest in recent years. Since 1988 it has been frequently used in the therapy of epilepsies but the mechanism of action is still unknown. It is considered to be low in adverse effects.
Vagus nerve stimulation for epilepsy: is output current correlated with acute response? [2007]Vagus nerve stimulation (VNS) is an effective treatment for intractable epilepsy. It is unknown whether acute response is correlated with the amplitude of output current. The purpose of this study was to determine if the output current of VNS is correlated with percent reductions in seizure frequency and response.
A prediction model integrating synchronization biomarkers and clinical features to identify responders to vagus nerve stimulation among pediatric patients with drug-resistant epilepsy. [2022]Vagus nerve stimulation (VNS) is a neuromodulation therapy for children with drug-resistant epilepsy (DRE). The efficacy of VNS is heterogeneous. A prediction model is needed to predict the efficacy before implantation.
Video EEG monitoring prior to vagal nerve stimulator implantation. [2019]Vagal nerve stimulation (VNS) is a safe alternative therapy for epilepsy but may have rare significant complications. There is no consensus regarding the necessity of video-EEG monitoring to characterize events before the VNS implantation. The authors discuss four patients who were inappropriately referred for or implanted with VNS without any previous video-EEG monitoring, in the context of their entire case experience.
Cardiac responses of vagus nerve stimulation: intraoperative bradycardia and subsequent chronic stimulation. [2022]Few adverse events on heart rate have been reported with vagus nerve stimulation (VNS) for refractory epilepsy. We describe three cases with intraoperative bradycardia during device testing.
Effectiveness of vagus nerve stimulation in epilepsy patients: a 12-year observation. [2019]A retrospective review of the safety, tolerability, and efficacy of vagus nerve stimulation (VNS) in 48 patients with intractable partial epilepsy was performed. Side effects were few and mild to moderate. Mean seizure frequency decreased by 26% after 1 year, 30% after 5 years, and 52% after 12 years with VNS treatment.
Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. [2022]Vagus nerve stimulation (VNS) is effective in refractory epilepsy and depression and is being investigated in heart failure, headache, gastric motility disorders and asthma. The first VNS device required surgical implantation of electrodes and a stimulator. Adverse events (AEs) are generally associated with implantation or continuous on-off stimulation. Infection is the most serious implantation-associated AE. Bradycardia and asystole have also been described during implantation, as has vocal cord paresis, which can last up to 6 months and depends on surgical skill and experience. The most frequent stimulation-associated AEs include voice alteration, paresthesia, cough, headache, dyspnea, pharyngitis and pain, which may require a decrease in stimulation strength or intermittent or permanent device deactivation. Newer non-invasive VNS delivery systems do not require surgery and permit patient-administered stimulation on demand. These non-invasive VNS systems improve the safety and tolerability of VNS, making it more accessible and facilitating further investigations across a wider range of uses.
Adverse events in children receiving intermittent left vagal nerve stimulation. [2019]The purpose of this study was to determine the frequency of unexpected events during intermittent vagal nerve stimulation in 24 patients stimulated for a total of 61 patient years. The charts of 24 children undergoing periodic stimulation of the left vagal nerve on research protocols were reviewed to determine the nature and frequency of adverse events and the total length of time they were stimulated. Fifteen adverse events were discovered in 12 patients. Thirteen were likely related to the device, and four other events might have been related. Two of these resulted in voluntary termination of vagal nerve stimulation, and the rest were treatable. Vagal nerve stimulation was tolerated in this series of patients. As opposed to the more standard drug therapies, adverse events during vagal nerve stimulation do not necessitate termination of therapy, but these events frequently lead to unforeseen surgery under general anesthesia.
The effect of vagal nerve stimulation on hippocampal-thalamic functional connectivity in epilepsy patients. [2021]Vagal nerve stimulation (VNS) is widely used as an auxiliary treatment for patients with intractable epilepsy. Up to now, the therapeutic mechanisms remain elusive, and no surgical prediction criteria has been proposed.
[Vagus nerve stimulation (VNS) in the treatment of drug-resistant epilepsy. A 4-year follow-up evaluation of VNS treatment efficacy]. [2015]Vagus nerve stimulation (VNS) is an alternative non-destructive surgical treatment for patients with medically intractable epilepsy. Neither the rationale nor proper indications for this treatment modality have been fully established yet.