NCT03930914

Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postural Orthostatic Tachycardia Syndrome

Interventions

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

Timeline

• Start date: 2019-11-04
• Primary completion: 2020-03-02
• Completion: 2021-12-07
• First posted: 2019-04-29
• Last updated: 2023-12-18

Locations

1 site across 1 country: United States