Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome

Postural Orthostatic Tachycardia Syndrome Clinical Trial

— POTS  

Official title:

Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930914
• Other study ID #: 10415
• Status: Completed
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: December 7, 2021

Study information

• Verified date: December 2023
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postural orthostatic tachycardia (POTS) is characterized by abnormalities in the autonomic nervous system in the body. The autonomic nervous system controls and regulates body functions such as heart rate, breathing, digestion, and more. The investigator has shown that patients with POTS have higher cardiovascular and adrenergic activating autoantibodies (AAb), which likely changes the normal make-up of POTS. There are autoantibodies that have been suggested by a few reports of their presence in POTS, but their role different aspects of POTS is unknown. The study will look at the body's responses in patients with POTS. The crossover study design is to have half of the patients will start with sham followed by active stimulation and half will start by active followed by sham stimulation. It is anticipated that results will provide a potential therapeutic approach based on the understanding of POTS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 7, 2021
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

-Female or male participants age 18-80

Group 1 (20 participants):

• A physician-based diagnosis of POTS
• Participants that have a postural pulse rise of >35 for adolescents and >30 for adults with a Blood Pressure (BP) that does not drop >10/5 mmHg will be qualified. These participants may be on salt and fluid loading.

Group 2 (10 participants):

• Previously diagnosed with POTS
• Patients is on Intravenous immunoglobulin (IVIG) infusion but who have an incomplete symptomatic response

Exclusion Criteria:

• Age < 18 years
• Sick sinus syndrome, 2nd or 3rd degree Atrioventricular (AV) block, bifascicular block or prolonged 1st degree AV block (PR>300ms).
• Currently pregnant women or women planning on becoming pregnant = 6 months
• History of hypotension due to autonomic dysfunction
• Have a secondary causes of tachycardia (acute anemia or blood loss, drugs, significant cardiomyopathy, diabetes mellitus)
• Patients with active implants (such as a cardiac pacemaker, or a cochlear implant).

Related Conditions & MeSH terms

• Postural Orthostatic Tachycardia Syndrome
• Syndrome
• Tachycardia

Intervention

Device:
• Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device
Daily use of Parasym (TM) device on tragus or ear lobe, as assigned treatment arm

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Dysautonomia International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average change in orthostatic heart rate	We will measure the average change in heart rate between supine and standing using continuous ECG after two and four months of daily vagal nerve stimulation	2 and 4 months
Primary	Long term effects on M2 muscarinic autoantibody levels	The average change in M2 muscarinic autoantibody levels measured from blood specimens obtained after two and four months of daily vagal nerve stimulation.	2 and 4 months
Primary	Long term effects on beta 1-adrenergic autoantibody levels	The average change in beta 1-adrenergic autoantibody levels measured from blood specimens obtained after two and four months of daily vagal nerve stimulation.	2 and 4 months
Primary	Long term effects on alpha 1-adrenergic autoantibody levels	The average change in alpha 1-adrenergic autoantibody levels measured from blood specimens obtained after two and four months of daily vagal nerve stimulation.	2 and 4 months
Primary	Average change in heart rate variability	We will measure the average change in heart rate variability based on 5 minute ECG after two and four months of daily vagal nerve stimulation	2 and 4 months