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出境医 / 临床实验 / Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome (POTS)
Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome (POTS)
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 | Intervention/treatment | Phase |
|---|---|---|
| Postural Orthostatic Tachycardia Syndrome | Device: Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| 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 4, 2019 |
| Estimated Primary Completion Date : | April 2021 |
| Estimated Study Completion Date : | January 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
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
|
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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 :
- 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
- 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.
- 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.
- 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.
- 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 Years 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 < 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).
Contacts and Locations
Locations
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
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 |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 8, 2019 | ||||||
| First Posted Date ICMJE | April 29, 2019 | ||||||
| Last Update Posted Date | April 14, 2020 | ||||||
| Actual Study Start Date ICMJE | November 4, 2019 | ||||||
| Estimated Primary Completion Date | April 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome | ||||||
| Official Title ICMJE | Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome | ||||||
| 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. |
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| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Postural Orthostatic Tachycardia Syndrome | ||||||
| Intervention ICMJE | Device: Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device
Daily use of Parasym (TM) device on tragus or ear lobe, as assigned treatment arm
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||
| Estimated Enrollment ICMJE |
30 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | January 2022 | ||||||
| Estimated Primary Completion Date | April 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria: -Female or male participants age 18-80 Group 1 (20 participants):
Group 2 (10 participants):
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03930914 | ||||||
| Other Study ID Numbers ICMJE | VNS in POTS | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University of Oklahoma | ||||||
| Study Sponsor ICMJE | University of Oklahoma | ||||||
| Collaborators ICMJE | Dysautonomia International | ||||||
| Investigators ICMJE |
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| PRS Account | University of Oklahoma | ||||||
| Verification Date | April 2020 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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