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Completed

NCT Number: NCT03930914

Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome

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.

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Key information

Conditions

Postural Orthostatic Tachycardia Syndrome Autonomic Nervous System Diseases Nervous System Diseases Orthostatic Intolerance Primary Dysautonomias

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device

Device

Daily use of Parasym (TM) device on tragus or ear lobe, as assigned treatment arm

Primary outcomes

  1. Average change in orthostatic heart rate

    Time frame: 2 and 4 months

    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. Long term effects on M2 muscarinic autoantibody levels

    Time frame: 2 and 4 months

    The average change in M2 muscarinic autoantibody levels measured from blood specimens obtained after two and four months of daily vagal nerve stimulation.

  3. Long term effects on beta 1-adrenergic autoantibody levels

    Time frame: 2 and 4 months

    The average change in beta 1-adrenergic autoantibody levels measured from blood specimens obtained after two and four months of daily vagal nerve stimulation.

  4. Long term effects on alpha 1-adrenergic autoantibody levels

    Time frame: 2 and 4 months

    The average change in alpha 1-adrenergic autoantibody levels measured from blood specimens obtained after two and four months of daily vagal nerve stimulation.

  5. Average change in heart rate variability

    Time frame: 2 and 4 months

    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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • Dysautonomia International

Registry information

Acronym: POTS

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 29, 2019
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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