Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome (POTS)
Postural Orthostatic Tachycardia Syndrome
About this trial
This is an interventional treatment trial for Postural Orthostatic Tachycardia Syndrome
Eligibility 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).
Sites / Locations
- University of Oklahoma Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Other
Other
Active Treatment to Sham
Sham to Active Treatment
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.
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.