Non-invasive Vagus Nerve Stimulation for Vaping

(nVNS Trial)

Recruiting at 1 trial location

Overseen By Vinay Parikh, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Temple University

Must not be taking: Hypertension meds, Arrhythmia meds

Disqualifiers: Pregnancy, Schizophrenia, Seizure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how gentle nerve stimulation, using a handheld device, might improve brain functions like attention and decision-making in people who use e-cigarettes. The device provides mild stimulation to the vagus nerve, located in the neck, which can influence brain activity. This method is known as non-invasive Vagus Nerve Stimulation (nVNS). Participants will receive either the real treatment or a placebo version and then take tests to assess changes in attention and executive function (decision-making skills). Ideal candidates for this trial are healthy young adults, aged 18-25, who currently or previously used e-cigarettes.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance brain health.

Will I have to stop taking my current medications?

If you are taking medications for high blood pressure, irregular heartbeats, or calcium channel blockers, you cannot participate in this trial.

What prior data suggests that this device is safe for cognitive functioning in users of e-cigarettes or vaping products?

A small study with 59 adults who have chronic migraines found that non-invasive vagus nerve stimulation (nVNS) was safe and generally well-tolerated. Most side effects were mild and temporary. Additionally, a larger review of similar treatments has shown a good safety record, supporting its use as a non-invasive option. This suggests the treatment is likely safe for most people, with only a few side effects that usually don't last long. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about non-invasive vagus nerve stimulation (nVNS) for vaping cessation because it offers a novel approach compared to traditional methods like nicotine replacement therapy or behavioral counseling. Unlike these standard treatments, nVNS uses a portable hand-held device to deliver mild electrical stimulation to the vagus nerve through the skin on the neck. This technique is unique because it targets the nervous system directly, potentially reducing cravings and withdrawal symptoms by modulating brain activity associated with addiction. By providing a non-invasive, drug-free alternative, nVNS could offer a new avenue for those seeking to quit vaping, with the added convenience of a simple, at-home treatment.

What evidence suggests that this device is effective for cognitive functioning in vaping users?

This trial will compare two approaches to non-invasive vagus nerve stimulation (nVNS) for vaping. Research has shown that nVNS might improve brain function by stimulating the vagus nerve, which connects the brain to the body. One study found that nVNS significantly reduced certain physical responses compared to no stimulation, suggesting it can effectively influence the nervous system. Another study found that nVNS might help reduce drug cravings, offering promise for people who vape. The treatment is known for quick results and minor side effects, making it a potentially safe option. Overall, early findings are encouraging for nVNS as a way to enhance brain functions. ^{1 2 3 6 7}

Who Is on the Research Team?

Jason Chein, PhD

Principal Investigator

Temple University

Vinay Parikh, PhD

Principal Investigator

Temple University

Tania Giovannetti, PhD

Principal Investigator

Temple University

Are You a Good Fit for This Trial?

This trial is for young adults who use e-cigarettes or vaping products. Participants will be tested to see if a non-invasive device that stimulates the vagus nerve can affect their attention and cognitive functioning.

Inclusion Criteria

Current or prior users of e-cigarettes

I am a healthy young adult.

Exclusion Criteria

I have a rash, infection, swelling, cut, soreness, drug patch, or surgical scar on my neck.

Have any implantable medical device in their body such as a pacemaker, hearing aid implant, or any other metallic/electronic device

Are pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a 2-min nNVS stimulation or control stimulation in the neck region followed by cognitive tests

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• nVNS

Trial Overview The study tests a digital wellness device (TRUVAGA™) providing mild stimulation to the vagus nerve through the skin. Participants are randomly assigned to receive either an active 2-minute stimulation or a placebo-like control, followed by cognitive tests.

How Is the Trial Designed?

Group I: Control Stimulation Experimental Treatment 1 Intervention

Participants in the control arm will receive a 2-min transcutaneous stimulation using a portable hand-held digital wellness Truvaga Plus device by placing it on the posterolateral part of the neck (near the overlapping area between the trapezeus muscle and the shoulder).

Group II: Active Stimulation Experimental Treatment 1 Intervention

Participants in the active arm will receive a 2-min transcutaneous vagus nerve stimulation using a portable hand-held digital wellness Truvaga Plus device by placing it on the anterolateral cervical area of the neck.

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials

321

Recruited

89,100+

Published Research Related to This Trial

In a study involving 28 healthy participants, noninvasive vagal nerve stimulation (nVNS) significantly reduced lacrimation compared to no stimulation and one type of sham stimulation, indicating its potential efficacy in modulating autonomic responses.

However, the study found that the sham device also produced similar effects, suggesting that both nVNS and the sham device can influence the trigeminal-autonomic reflex, which may explain the high placebo effects seen in previous clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

nVNS sham significantly affects the trigeminal-autonomic reflex: A randomized controlled study. Schroeder, CF., Möller, M., May, A.[2020]

In a study involving 15 patients with chronic pelvic pain due to endometriosis, respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) showed a trend towards reducing pain intensity and significantly decreased anxiety compared to nonvagal auricular stimulation (NVAS).

RAVANS demonstrated moderate to large effect sizes in reducing pain and anxiety, suggesting it could be a promising nonpharmacological treatment option for chronic pain disorders, warranting further investigation into its long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evoked pain analgesia in chronic pelvic pain patients using respiratory-gated auricular vagal afferent nerve stimulation. Napadow, V., Edwards, RR., Cahalan, CM., et al.[2022]

Noninvasive vagus nerve stimulation (nVNS) was found to be safe and well-tolerated in a pilot study involving 59 adults with chronic migraine, with most adverse events being mild and transient.

While nVNS did not show a significant reduction in headache days compared to sham treatment during the randomized phase, participants who continued with nVNS in the open-label phase experienced a meaningful decrease in headache days after 8 months, suggesting potential long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study. Silberstein, SD., Calhoun, AH., Lipton, RB., et al.[2022]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive and cost-effective method for modulating the vagus nerve, making it a promising alternative to traditional surgical vagus nerve stimulation.

taVNS allows for easy and safe administration, with considerations for proper electrode placement and individual dosing based on perception thresholds, which enhances its potential for treating various central and peripheral diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. Badran, BW., Yu, AB., Adair, D., et al.[2020]

Selective stimulation of specific populations of vagal afferents using a multi-contact cuff electrode was successfully demonstrated in six ferrets, allowing targeted activation of vagal neurons without affecting other organs.

Abdominal vagus nerve stimulation (VNS) was shown to selectively alter gastric myoelectric activity, indicating its potential as a therapeutic approach for controlling gastrointestinal function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective stimulation of the ferret abdominal vagus nerve with multi-contact nerve cuff electrodes. Shulgach, JA., Beam, DW., Nanivadekar, AC., et al.[2022]

Vagus nerve stimulation (VNS) is an FDA-approved treatment for epilepsy, morbid obesity, and treatment-resistant depression, but it is often underutilized due to high costs and the need for surgical implantation.

The development of transcutaneous auricular VNS (taVNS) offers a promising noninvasive alternative that could provide a safe, at-home treatment option for various neuropsychiatric disorders, with ongoing trials like the RECOVER trial evaluating its efficacy in treatment-resistant depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Future Is Noninvasive: A Brief Review of the Evolution and Clinical Utility of Vagus Nerve Stimulation. Badran, BW., Austelle, CW.[2023]

A high-resolution model of cervical non-invasive vagus nerve stimulation (nVNS) was developed using MRI-derived Finite Element Method (FEM) to accurately predict how different types of vagus nerve fibers are activated, showing that both macro and mesoscopic anatomical details are crucial for accurate predictions.

The model predicts that conventional nVNS protocols can effectively activate A- and B-fibers, which are important for therapeutic effects, but not C-fibers, highlighting the need for precise modeling in optimizing vagus nerve stimulation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Resolution Multi-Scale Computational Model for Non-Invasive Cervical Vagus Nerve Stimulation. Mourdoukoutas, AP., Truong, DQ., Adair, DK., et al.[2022]

This study reports the first-ever recordings from the human cervical vagus nerve using ultrasound-guided tungsten microelectrodes, allowing for a deeper understanding of its physiology in awake humans.

The recordings revealed that certain neurons in the vagus nerve are tonically active and their firing rates are inversely related to heart rate, suggesting their role as preganglionic parasympathetic axons that influence heart function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo recordings from the human vagus nerve using ultrasound-guided microneurography. Ottaviani, MM., Wright, L., Dawood, T., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06804109

Non-invasive Vagus Nerve Stimulation (nVNS) and ... The purpose of this study is to assess the effects of non-invasive vagus nerve stimulation (nNVS) on cognitive functioning in the users of e-cigarettes or ...

2. trial.medpath.com trial.medpath.com/clinical-trial/b7bd50a94d9e3efa/non-invasive-vagus-nerve-stimulation-cognition

Non-invasive Vagus Nerve Stimulation (nVNS) and Cognition ... The purpose of this study is to assess the effects of non-invasive vagus nerve stimulation (nNVS) on cognitive functioning in the users of e-cigarettes or ...

3. withpower.com withpower.com/trial/non-invasive-vagus-nerve-stimulation-for-vaping-3d979

Non-invasive Vagus Nerve Stimulation for Vaping In a study involving 28 healthy participants, noninvasive vagal nerve stimulation (nVNS) significantly reduced lacrimation compared to no stimulation and one ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11486613/

Efficacy and safety of non-invasive brain stimulation ... The clinical benefits of NIBS, including the fast onset and minor side effects, showed that this kind of treatment could be helpful in patients ...

5. news.utdallas.edu news.utdallas.edu/health-medicine/vns-drug-addiction-treatment-2024/

Neuroscientists Show How VNS May Enhance Drug ... Sven Kroener, associate professor of neuroscience, demonstrated that vagus nerve stimulation might help retrain the brain to decrease drug- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10699253/

Noninvasive Vagal Nerve Stimulation for Opioid Use Disorder NVNS shows promise as a non-medication approach to OUD, both in terms of its known effect on neurobiology as well as pilot data showing a reduction in ...

7. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2025.1539416/full

A pooled analysis of the side effects of non-invasive ... These findings demonstrate a favorable safety profile of taVNS, with mostly mild and transient effects, supporting its use as a suitable non-invasive tool.