Postural Orthostatic Tachycardia SyndromePOTSNCT03930914
Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome
A study testing Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device in people with Postural Orthostatic Tachycardia Syndrome, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postural Orthostatic Tachycardia Syndrome
- What is being tested?
- Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2019to 7 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
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.
- Being tested
- Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) DeviceDevice
Daily use of Parasym (TM) device on tragus or ear lobe, as assigned treatment arm
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 2 and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start4 Nov 2019
- Primary completion2 Mar 2020
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural Orthostatic Tachycardia SyndromeStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Dysautonomia International
- Responsible party
- Sponsor
- Investigators
- Xichun Yu, MD, Principal investigator, University of OklahomaStavros Stavrakis, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930914
- Sponsor's protocol ID
- 10415
- Acronym
- POTS
- Status last verified
- Dec 2023
- First submitted
- 8 Apr 2019
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome
- ClinicalTrials.gov ID
- NCT03930914
- Acronym / sponsor ID
- POTS / 10415
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Dysautonomia International
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment to Sham | Other | Device: Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) DeviceSubjects 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. |
| Sham to Active Treatment | Other | Device: Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) DeviceSubjects 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- -Female or male participants age 18-80
- 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.
- Previously diagnosed with POTS
- Patients is on Intravenous immunoglobulin (IVIG) infusion but who have an incomplete symptomatic response
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) DeviceDaily use of Parasym (TM) device on tragus or ear lobe, as assigned treatment arm | Device | Active Treatment to Sham, Sham to Active Treatment |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xichun Yu, MD principal investigator
University of Oklahoma
Stavros Stavrakis, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device in people with Postural Orthostatic Tachycardia Syndrome, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average change in orthostatic heart rate (time frame: 2 and 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.