Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome (POTS)

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.

Study Overview

• Status: Completed
• Conditions: Postural Orthostatic Tachycardia Syndrome
• Intervention / Treatment: Device: Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Active Treatment to Sham; Subjects randomized to the sequence Active Treatment/Sham Treatment arm will be instructed to first use the Parasym (TM) TENS device as active treatment for the first phase of the study. Next, they will be instructed to use the Parasym (TM) TENS device as sham treatment for the second phase of the study.	Device: Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device; Daily use of Parasym (TM) device on tragus or ear lobe, as assigned treatment arm
Other: Sham to Active Treatment; Subjects randomized to the sequence Sham Treatment/Active Treatment arm will be instructed to use the Parasym (TM) TENS device as sham treatment for the first phase of the study. Next, they will be instructed to use the Parasym (TM) TENS device as active treatment for the second phase of the study.	Device: Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device; Daily use of Parasym (TM) device on tragus or ear lobe, as assigned treatment arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: Dysautonomia International
• Investigators: Principal Investigator: Stavros Stavrakis, MD, University of Oklahoma; Principal Investigator: Xichun Yu, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Actual): March 2, 2020
• Study Completion (Actual): December 7, 2021

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Disease; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Autonomic Nervous System Diseases; Primary Dysautonomias; Orthostatic Intolerance; Syndrome; Tachycardia; Postural Orthostatic Tachycardia Syndrome
• Other Study ID Numbers: 10415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No