Healthy VolunteersTEACAPNCT02910973
Using a Transcutaneous Electrical Auricular Stimulator to Harness the Cholinergic Anti-Inflammatory Pathway
A study testing Vagus Nerve Stimulation in people with Healthy Volunteers, run by Northwell Health at 1 site in United States.
Trial summary
Persistent chronic inflammation is an important underlying event in multiple diseases including rheumatoid arthritis, inflammatory bowel diseases and type 2 diabetes. These disorders are characterized as inflammatory in part because of the important mediating role of pro-inflammatory cytokines in their pathogenesis. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 13 Dec 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-60 years,
- Currently healthy with no medical problems
- Able and willing to give written informed consent and comply with the requirements of the study protocol.
Who cannot join
- History of any of the following: cardiac arrhythmia, coronary artery disease, autoimmune disease, chronic inflammatory disease, anemia, malignancy, depression, neurologic disease, diabetes mellitus, renal disease, malignancy, dementia, psychiatric illness including active psychosis, or any other chronic medical condition.
- Family history of inflammatory disease
- Treatment with an anti-cholinergic medication, including over the counter medications,
- Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
- Current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine),
- Chronic inflammatory disorders
Show all 12Show fewer
- Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing (Day 0), whichever is the greater length of time,
- Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention,
- Pregnancy or lactation (Pregnancy status \& lactation will be determined via self-report),
- Implanted vagus nerve stimulator
- Inability to comply with study procedures
- Ear infection (otitis media or externa)
Trial locations and contacts
1 site in 1 country.
About this study
Persistent chronic inflammation is an important underlying event in multiple diseases including rheumatoid arthritis, inflammatory bowel diseases and type 2 diabetes. These disorders are characterized as inflammatory in part because of the important mediating role of pro-inflammatory cytokines in their pathogenesis. This study will investigate whether transcutaneous auricular electrical stimulation of the vagus nerve will affect and decrease the inflammatory cytokine response in healthy individuals.
- Conditions
- Healthy Volunteers
- Being tested
- Vagus Nerve Stimulation, Sham Vagus Nerve Stimulation
- Keywords
- Inflammation, Vagus Nerve Stimulation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus Nerve StimulationDevice
Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes. Blood will be withdrawn prior to stimulation and 1 hour following the stimulation. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch of the vagus nerve.
Sham Vagus Nerve StimulationDevice
Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes. Blood will be withdrawn prior to stimulation and 1 hour following the stimulation. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
| Study group | Role | What they receive |
|---|---|---|
| Vagus Nerve Stimulation | Active comparator | Device: Vagus nerve stimulation Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes. Receives: Device: Vagus Nerve Stimulation |
| Sham Vagus Nerve Stimulation | Sham comparator | Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes. Receives: Device: Sham Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipopolysaccharide stimulated levels of TNF in whole blood.
Whole blood will be taken from patients and stimulated by lipopolysaccharide. Levels of TNF produced by the cells in the whole blood after 4 hours of incubation will be measured.
Measured: 4 hours
Secondary outcomes (2)
Lipopolysaccharide stimulated levels of cytokines such as IL-1, IL-6, IL-8, IL-10 and HMGB1 in whole blood.
Whole blood will be taken from patients and stimulated by lipopolysaccharide. Levels of cytokines such as IL-1, IL-6, IL-8, IL-10 and HMGB1 that are produced by the cells in the whole blood after 4 hours of incubation will be measured.
Measured: 4 hours
Percentage of subjects with treatment emergent adverse events
The percentage of participants with treatment emergent adverse events will be assessed using the NCI-CTAEversion4.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion13 Dec 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Aranow, MD, Northwell Health
- Investigators
- Cynthia Aranow, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910973
- Sponsor's protocol ID
- HS16-0530
- Acronym
- TEACAP
- Status last verified
- Feb 2024
- First submitted
- 20 Sep 2016
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Transcutaneous Electrical Auricular Stimulator to Harness the Cholinergic Anti-Inflammatory Pathway
- ClinicalTrials.gov ID
- NCT02910973
- Acronym / sponsor ID
- TEACAP / HS16-0530
- Conditions
- Healthy Volunteers
- Keywords
- Inflammation, Vagus Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 22 Sep 2016 (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.
Persistent chronic inflammation is an important underlying event in multiple diseases including rheumatoid arthritis, inflammatory bowel diseases and type 2 diabetes. These disorders are characterized as inflammatory in part because of the important mediating role of pro-inflammatory cytokines in their pathogenesis. This study will investigate whether transcutaneous auricular electrical stimulation of the vagus nerve will affect and decrease the inflammatory cytokine response in healthy individuals.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vagus Nerve Stimulation | Active comparator | Device: Vagus Nerve StimulationDevice: Vagus nerve stimulation Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes. |
| Sham Vagus Nerve Stimulation | Sham comparator | Device: Sham Vagus Nerve StimulationPatients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18-60 years,
- Currently healthy with no medical problems
- Able and willing to give written informed consent and comply with the requirements of the study protocol.
Key exclusion criteria (12 listed)
- History of any of the following: cardiac arrhythmia, coronary artery disease, autoimmune disease, chronic inflammatory disease, anemia, malignancy, depression, neurologic disease, diabetes mellitus, renal disease, malignancy, dementia, psychiatric illness including active psychosis, or any other chronic medical condition.
- Family history of inflammatory disease
- Treatment with an anti-cholinergic medication, including over the counter medications,
- Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
- Current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine),
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 |
|---|---|---|
| Vagus Nerve StimulationPatients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes. Blood will be withdrawn prior to stimulation and 1 hour following the stimulation. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch of the vagus nerve. | Device | Vagus Nerve Stimulation |
| Sham Vagus Nerve StimulationPatients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes. Blood will be withdrawn prior to stimulation and 1 hour following the stimulation. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve. | Device | Sham Vagus Nerve Stimulation |
Primary outcome
Lipopolysaccharide stimulated levels of TNF in whole blood.
Time frame: 4 hours
Whole blood will be taken from patients and stimulated by lipopolysaccharide. Levels of TNF produced by the cells in the whole blood after 4 hours of incubation will be measured.
2 secondary outcomes
Lipopolysaccharide stimulated levels of cytokines such as IL-1, IL-6, IL-8, IL-10 and HMGB1 in whole blood.
Time frame: 4 hours
Percentage of subjects with treatment emergent adverse events
Time frame: 1 hour
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 22 Feb 2024.
- 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.
Cynthia Aranow, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus Nerve Stimulation in people with Healthy Volunteers, run by Northwell Health 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 3 inclusion and 12 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 22 Feb 2024. 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?
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?
Lipopolysaccharide stimulated levels of TNF in whole blood. (time frame: 4 hours). 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 22 Feb 2024.