Postural Orthostatic Tachycardia SyndromeNCT02281097
Transdermal Vagal Stimulation for POTS
A study testing Stimulation in people with Postural Orthostatic Tachycardia Syndrome, run by Vanderbilt University at 1 site in United States.
Trial summary
Some patients experience high heart rates and symptoms of light-headedness, fatigue, headache during standing despite well maintained blood pressure. These patient are disabled and can't be in upright position for a longer time. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postural Orthostatic Tachycardia Syndrome
- What is being tested?
- Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-smoking patients who qualify with the criteria of idiopathic postural tachycardia syndrome will be studied. The criteria are:
- an increase of heart rate of 30 beats/minute or an upright heart rate of >= 120 bpm, and
- chronic problems of symptoms during upright posture for at least 6 month.
- Subjects must also be able to safely withdrawn from medications that influence heart rate, blood pressure, and hormone levels that regulate blood pressure.
- The age limit is 18-75 years.
Who cannot join
- Patients that have other major medical problems, such as cancer or heart disease are excluded because the influence of that diagnosis on the symptoms is not known.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Autonomic Dysfunction Center, Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2195
About this study
Official title: Transdermal Vagal Stimulation for the Treatment of Postural Tachycardia Syndrome
Some patients experience high heart rates and symptoms of light-headedness, fatigue, headache during standing despite well maintained blood pressure.
These patient are disabled and can't be in upright position for a longer time. The purpose of this study is to test whether electrical stimulation of a nerve through a skin of the ear may improve heart rate response and reduce disabling symptoms.
Read the detailed description
Background Postural Tachycardia Syndrome (POTS) is a syndrome characterized by disabling symptoms of inadequate cerebral perfusion on assuming the upright posture, including light-headedness, fatigue, palpitations, altered mentation, headache, nausea, presyncope, and occasionally syncope.
POTS is characterized by an excessive increase in heart rate and exaggerated increase in plasma catecholamine levels on standing in the absence of a blood pressure fall. These disabling symptoms persist for more than six months.
Objective The objective of this study is to study the effect of vagal stimulation on heart rate modulation during supine and upright posture as a treatment modality for patients with POTS.
- Being tested
- Stimulation, Placebo
- Keywords
- Postural Orthostatic Tachycardia Syndrome, POTS, Vagal Stimulation
- 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.
StimulationOther
Application of current to skin above auricular branch of vagal nerve to modulate heart rate and symptoms
PlaceboOther
Application of low intensive current or frequency to skin above auricular branch of vagal nerve as sham intervention
| Study group | Role | What they receive |
|---|---|---|
| Vagal Stimulation First | Active comparator | Vagal stimulation to improve upright heart rate modulation and symptoms is given on first tilt study day.
Placebo stimulation with ineffective low amplitude and frequency (sham intervention) is given on second tilt study. Receives: Other: Stimulation; Other: Placebo |
| Placebo First | Placebo comparator | Placebo stimulation with ineffective low amplitude and frequency (sham intervention) is given on first tilt study day.
Vagal stimulation to improve upright heart rate modulation and symptoms is given on second tilt study day. Receives: Other: Stimulation; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate (average of 1 minute)
Upright heart rate and heart rate change from supine measured during graded tilt with 15 degrees increments each 5 minutes till 30 min of 75 degrees or abort.
Measured: [-5,0,5,10,15,20,..,50 min] relative time from tilt
Secondary outcomes (2)
Orthostatic Symptoms (Subjective analog symptoms scale (0-100)
Subjective analog symptoms scale (0-100)
Measured: [-5,0,5,10,15,20,..,50 min] relative time from tilt
Orthostatic Tolerance (Maximal tolerated time in upright position)
Maximal tolerated time in upright position
Measured: [0-50 min] relative time from tilt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startJun 2013
- Primary completionApr 2017
- Study completion31 Dec 2026 (estimated)
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre' Diedrich, Vanderbilt University
- Investigators
- Andre Diedrich, MD, PhD, Principal investigator, Vanderbilt University Medical CenterItalo Biaggioni, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281097
- Sponsor's protocol ID
- VANDERBILT_IRB_121816
- Status last verified
- Mar 2026
- First submitted
- 21 Oct 2014
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No. There is no plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdermal Vagal Stimulation for the Treatment of Postural Tachycardia Syndrome
- ClinicalTrials.gov ID
- NCT02281097
- Acronym / sponsor ID
- VANDERBILT_IRB_121816
- Keywords
- Postural Orthostatic Tachycardia Syndrome, POTS, Vagal Stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Nov 2014 (estimated)
- 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.
Some patients experience high heart rates and symptoms of light-headedness, fatigue, headache during standing despite well maintained blood pressure.
These patient are disabled and can't be in upright position for a longer time. The purpose of this study is to test whether electrical stimulation of a nerve through a skin of the ear may improve heart rate response and reduce disabling symptoms.
Detailed description
Background Postural Tachycardia Syndrome (POTS) is a syndrome characterized by disabling symptoms of inadequate cerebral perfusion on assuming the upright posture, including light-headedness, fatigue, palpitations, altered mentation, headache, nausea, presyncope, and occasionally syncope.
POTS is characterized by an excessive increase in heart rate and exaggerated increase in plasma catecholamine levels on standing in the absence of a blood pressure fall. These disabling symptoms persist for more than six months.
Objective The objective of this study is to study the effect of vagal stimulation on heart rate modulation during supine and upright posture as a treatment modality for patients with POTS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vagal Stimulation First | Active comparator | Other: Stimulation, Other: PlaceboVagal stimulation to improve upright heart rate modulation and symptoms is given on first tilt study day. Placebo stimulation with ineffective low amplitude and frequency (sham intervention) is given on second tilt study. |
| Placebo First | Placebo comparator | Other: Stimulation, Other: PlaceboPlacebo stimulation with ineffective low amplitude and frequency (sham intervention) is given on first tilt study day. Vagal stimulation to improve upright heart rate modulation and symptoms is given on second tilt study day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-smoking patients who qualify with the criteria of idiopathic postural tachycardia syndrome will be studied. The criteria are:
- Subjects must also be able to safely withdrawn from medications that influence heart rate, blood pressure, and hormone levels that regulate blood pressure.
- The age limit is 18-75 years.
Key exclusion criteria (2 listed)
- Patients that have other major medical problems, such as cancer or heart disease are excluded because the influence of that diagnosis on the symptoms is not known.
- Pregnancy.
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 |
|---|---|---|
| StimulationApplication of current to skin above auricular branch of vagal nerve to modulate heart rate and symptoms | Other | Placebo First, Vagal Stimulation First |
| PlaceboApplication of low intensive current or frequency to skin above auricular branch of vagal nerve as sham intervention | Other | Placebo First, Vagal Stimulation First |
Primary outcome
Heart Rate (average of 1 minute)
Time frame: [-5,0,5,10,15,20,..,50 min] relative time from tilt
Upright heart rate and heart rate change from supine measured during graded tilt with 15 degrees increments each 5 minutes till 30 min of 75 degrees or abort.
2 secondary outcomes
Orthostatic Symptoms (Subjective analog symptoms scale (0-100)
Time frame: [-5,0,5,10,15,20,..,50 min] relative time from tilt
Orthostatic Tolerance (Maximal tolerated time in upright position)
Time frame: [0-50 min] relative time from tilt
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Vanderbilt Autonomic Dysfunction CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No. No. There is no plan to share data.
Related trials for Postural Orthostatic Tachycardia Syndrome
Recruiting
Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome
Postural Tachycardia Syndrome
Enrolling by invitationObservational study
Presentation of Young Adults With and Without Joint Hypermobility
Hypermobile Ehlers-Danlos Syndrome, Postural Orthostatic Tachycardia Syndrome (POTS)
Active, not recruiting
Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)
Postural Tachycardia Syndrome
Active, not recruitingPhase 1/2
Treatment of Orthostatic Intolerance
Tachycardia, Chronic Orthostatic Intolerance
Active, not recruiting
Acute Salt Handling in Orthostatic Intolerance
Postural Tachycardia Syndrome, Orthostatic Tachycardia
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.
Andre Diedrich, MD, PhD principal investigator
Vanderbilt University Medical Center
Italo Biaggioni, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation in people with Postural Orthostatic Tachycardia Syndrome, run by Vanderbilt University 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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Heart Rate (average of 1 minute) (time frame: [-5,0,5,10,15,20,..,50 min] relative time from tilt). 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 27 Mar 2026.