Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome
NCT ID: NCT03930914
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2019-11-04
2021-12-07
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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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.
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.
Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device
Daily use of Parasym (TM) device on tragus or ear lobe, as assigned treatment arm
Interventions
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Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device
Daily use of Parasym (TM) device on tragus or ear lobe, as assigned treatment arm
Eligibility Criteria
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Inclusion Criteria
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
* 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).
18 Years
80 Years
ALL
No
Sponsors
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Dysautonomia International
OTHER
University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Xichun Yu, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma
Stavros Stavrakis, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma
Locations
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Countries
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Other Identifiers
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10415
Identifier Type: -
Identifier Source: org_study_id