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

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ClinicalTrials.gov Identifier: NCT03930914
Recruitment Status : Unknown
Verified April 2020 by University of Oklahoma.
Recruitment status was:  Active, not recruiting
First Posted : April 29, 2019
Last Update Posted : April 14, 2020
Sponsor:
Collaborator:
Dysautonomia International
Information provided by (Responsible Party):
University of Oklahoma

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Postural Orthostatic Tachycardia Syndrome Device: Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : January 2022
Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930914


Locations
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United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Dysautonomia International
Investigators
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Principal Investigator: David Kem, MD University of Oklahoma
Principal Investigator: Stavros Stavrakis, MD University of Oklahoma
More Information
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03930914    
Other Study ID Numbers: VNS in POTS
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postural Orthostatic Tachycardia Syndrome
Tachycardia
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Cardiac Conduction System Disease
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases