Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome

NCT03930914 | Completed DMC

• 1 other identifier: 10415
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Postural Orthostatic Tachycardia Syndrome

Outcome Measures

Primary Outcomes (5)

• Average change in orthostatic heart rate

  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 and 4 months

• Long term effects on M2 muscarinic autoantibody levels

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

  2 and 4 months

• Long term effects on beta 1-adrenergic autoantibody levels

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

  2 and 4 months

• Long term effects on alpha 1-adrenergic autoantibody levels

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

  2 and 4 months

• Average change in heart rate variability

  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

  2 and 4 months

Study Arms (2)

Active Treatment to Sham

OTHER

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

Sham to Active Treatment

OTHER

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

Interventions

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

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

Active Treatment to Sham; Sham to Active Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Oklahoma: lead
• Dysautonomia International: collaborator

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Xichun Yu, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

• Stavros Stavrakis, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 29, 2019
• Study Start: November 4, 2019
• Primary Completion: March 2, 2020
• Study Completion: December 7, 2021
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)