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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome

Clinicaltrials.gov identifier NCT03930914

Recruitment Status Active, not recruiting

First Posted April 29, 2019

Last update posted April 14, 2020

Study Description

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:Postural Orthostatic Tachycardia Syndrome
  • Intervention/Treatment: Device: Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: January 2022
Arms and interventions
Arm Intervention/treatment
Other: 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
Other: 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
  • 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
  • Ages Eligible for Study: 18 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 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
Contacts
Locations

United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City

Sponsors and Collaborators

University of Oklahoma

Dysautonomia International

Investigators

Principal Investigator: David Kem, MD University of Oklahoma

Principal Investigator: Stavros Stavrakis, MD University of Oklahoma

More Information
  • Responsible Party: University of Oklahoma
  • ClinicalTrials.gov Identifier: NCT03930914 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Postural Orthostatic Tachycardia Syndrome
    Tachycardia
    Syndrome