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

Primary Purpose

Postural Orthostatic Tachycardia Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postural Orthostatic Tachycardia Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Other

Other

Arm Label

Active Treatment to Sham

Sham to Active Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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.
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.
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.
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

Secondary Outcome Measures

Full Information

First Posted
April 8, 2019
Last Updated
April 10, 2020
Sponsor
University of Oklahoma
Collaborators
Dysautonomia International
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1. Study Identification

Unique Protocol Identification Number
NCT03930914
Brief Title
Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome
Acronym
POTS
Official Title
Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
Dysautonomia International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Orthostatic Tachycardia Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment to Sham
Arm Type
Other
Arm Description
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.
Arm Title
Sham to Active Treatment
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device
Intervention Description
Daily use of Parasym (TM) device on tragus or ear lobe, as assigned treatment arm
Primary Outcome Measure Information:
Title
Average change in orthostatic heart rate
Description
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
Time Frame
2 and 4 months
Title
Long term effects on M2 muscarinic autoantibody levels
Description
The average change in M2 muscarinic autoantibody levels measured from blood specimens obtained after two and four months of daily vagal nerve stimulation.
Time Frame
2 and 4 months
Title
Long term effects on beta 1-adrenergic autoantibody levels
Description
The average change in beta 1-adrenergic autoantibody levels measured from blood specimens obtained after two and four months of daily vagal nerve stimulation.
Time Frame
2 and 4 months
Title
Long term effects on alpha 1-adrenergic autoantibody levels
Description
The average change in alpha 1-adrenergic autoantibody levels measured from blood specimens obtained after two and four months of daily vagal nerve stimulation.
Time Frame
2 and 4 months
Title
Average change in heart rate variability
Description
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
Time Frame
2 and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kem, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stavros Stavrakis, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome

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