VapingnVNSNCT06804109
Non-invasive Vagus Nerve Stimulation (nVNS) and Cognition in Young Adult Vapers - A Pilot Study
A study testing Active nVNS in people with Vaping, run by Temple University at 1 site in United States.
Trial summary
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 vaping products. The investigators will use a digital wellness companion product (TRUVAGA™ device) that provides mild transcutaneous nVNS. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaping
- What is being tested?
- Active nVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2025to 9 Feb 2028
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young adults
- Age range 18-25 years
- Current or prior users of e-cigarettes
Who cannot join
- Participants will be excluded from the study if they:
- Have any rash, infection, swelling, cut, soreness, drug patch, surgical scar on the neck area
- Have any implantable medical device in their body such as a pacemaker, hearing aid implant, or any other metallic/electronic device
- Have any hearing or vision problems that are not corrected
- Are pregnant or breastfeeding
- Have any learning disabilities
Show all 20Show fewer
- Have a medical history of any of the following condition
- Meningitis
- Traumatic brain injury
- Seizure
- Syncope
- Schizophrenia
- Schizoaffective disorder
- Bulimia (eating disorder)
- Other serious neurological illness
- Have a medical history of any of the following cardiac disorder
- Carotid atherosclerosis or carotid artery disease
- Cervical vagotomy
- First degree atrioventricular block or prolonged QT interval
- Are taking any medications for to treat hypertension, arrhythmias, or are on calcium channel blockers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19122
About this study
Official title: Vaping and Vagal Neuromodulation of 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 vaping products. The investigators will use a digital wellness companion product (TRUVAGA™ device) that provides mild transcutaneous nVNS. The participants will be randomized to receive either a 2-min nNVS stimulation or control stimulation in the neck region followed by completion of three cognitive tests of attention and executive function.
Read the detailed description
Electronic cigarettes, also referred to as e-cigarettes or vapes were initially developed as a smoking cessation tool and considered less harmful, but the presence of nicotine in the vapes make them highly addictive. The use of E-cigarettes has dramatically increased among the youth and young adults in the last decade. While the risks associated with traditional, combustible cigarette smoking are "well-established," vaping also exposes individuals to nicotine which is highly addictive and it can have long-term detrimental effects on the brain. Impairments in cognitive processes including attention and executive functions are suggested to contribute to the development and maintenance of sustained nicotine use in addicts and improving these processes may have some benefits. One of the ascending neuromodulatory input system, the cholinergic system, is implicated in the regulation of attention and higher-order cognitive processes. The stimulation of peripheral vagus nerve is known to activate ascending neuromodulators in the brain including the cholinergic system. This pilot project will use a single blind between-subjects randomized design to investigate the effects of non-invasive vagus nerve stimulation (nNVS) on attentional capacities in e-cigarette users. The study will involve administration of self-report surveys regarding vaping dependence and craving, measures of attention, impulsivity, anxiety and negative emotional states, and two quick behavioral tests (reaction time and lexical retrieval) to assess baseline measures of processing speed and executive function. For baseline processing speed assessment, the participants will complete a quick (3-5 min) simple and choice Reaction Time task on a computer prior to the intervention. The lexical retrieval efficiency will be assessed by 1-min Verbal Fluency Test prior to the intervention. Following this, the participants will be randomized to receive either a 2-min nNVS stimulation or control stimulation in the neck region using a portable TruvagaTM Plus device (electroCore). This digital device is a general health and wellness (Digital Health) product and is not intended to diagnose, cure, mitigate, treat, or prevent any disease. The subjects will complete three neuropsychological tests of attention and executive function (Attention Network Test, Symbol Digit Modalities Test, and Verbal Fluency Test) immediately after the intervention. The 1-min Verbal Fluency Test will be completed by the participants both before (pre-test) and after (post-test) the intervention. The specific goals of the study are: 1) To test the hypothesis that e-cigarette users given acute transcutaneous nNVS will perform better on tasks of attention as compared to e-cigarette users given control stimulation. 2): To test the hypothesis that cognitive benefits of nNVS in e-cigarette users will be associated with the degree of nicotine dependence and the magnitude of negative affective states.
- Conditions
- Vaping
- Being tested
- Active nVNS, Control nVNS
- Keywords
- vaping, attention, non-invasive vagus nerve stimulation
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active nVNSDevice
2-min transcutaneous nVNS stimulation using portable Truvaga Plus Device (electroCore Inc., Rockaway, NJ).
Control nVNSDevice
2-min control stimulation using portable Truvaga Plus Device (electroCore Inc., Rockaway, NJ).
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Experimental | 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. Receives: Device: Active nVNS |
| Control Stimulation | Experimental | 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). Receives: Device: Control nVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of Attentional Networks using the Attention Network task (ANT)
The Attentional Network Task (ANT) measures alerting, orienting, and executive attention that combines spatial cues with different flanker conditions. The efficiency of these three attentional networks is assessed by averaging reaction times and accuracy.
Measured: Immediately after intervention
Attention and Processing Speed using the Symbol Digit Modalities Test (SDMT)
The Symbol Digit Modalities Test (SDMT) is a sensitive and reliable neuropsychological test for the evaluation of speed of information processing, scanning and tracking aspects of attention, and working memory. SDMT is a simple substitution task that uses a reference key for the participants to pair specific numbers with given geometric figures. The test score is calculated based on the number of correct responses in 90 seconds.
Measured: Immediately after intervention
Lexical Retrieval using the Verbal Fluency Task
The Verbal Fluency Task is a neuropsychological measure of lexical retrieval efficiency and executive functioning. In this test, the participants are asked to name the words that starts with a specific alphabet (phonemic fluency) in 60 seconds. The verbal fluency score is calculated based on the number of correct/acceptable words produced within the allotted time.
Measured: Before and immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start18 Mar 2025
- Primary completion9 Feb 2027 (estimated)
- Study completion9 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VapingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vinay Parikh, PhD, Principal investigator, Temple UniversityJason Chein, PhD, Principal investigator, Temple UniversityTania Giovannetti, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804109
- Sponsor's protocol ID
- IRB31783
- Acronym
- nVNS
- Status last verified
- Mar 2026
- First submitted
- 27 Jan 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaping and Vagal Neuromodulation of Cognition
- ClinicalTrials.gov ID
- NCT06804109
- Acronym / sponsor ID
- nVNS / IRB31783
- Conditions
- Vaping
- Keywords
- vaping, attention, non-invasive vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 9 Feb 2027 (estimated)
- Study completion
- 9 Feb 2028 (estimated)
- First posted
- 31 Jan 2025 (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.
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 vaping products. The investigators will use a digital wellness companion product (TRUVAGA™ device) that provides mild transcutaneous nVNS. The participants will be randomized to receive either a 2-min nNVS stimulation or control stimulation in the neck region followed by completion of three cognitive tests of attention and executive function.
Detailed description
Electronic cigarettes, also referred to as e-cigarettes or vapes were initially developed as a smoking cessation tool and considered less harmful, but the presence of nicotine in the vapes make them highly addictive. The use of E-cigarettes has dramatically increased among the youth and young adults in the last decade. While the risks associated with traditional, combustible cigarette smoking are "well-established," vaping also exposes individuals to nicotine which is highly addictive and it can have long-term detrimental effects on the brain. Impairments in cognitive processes including attention and executive functions are suggested to contribute to the development and maintenance of sustained nicotine use in addicts and improving these processes may have some benefits. One of the ascending neuromodulatory input system, the cholinergic system, is implicated in the regulation of attention and higher-order cognitive processes. The stimulation of peripheral vagus nerve is known to activate ascending neuromodulators in the brain including the cholinergic system. This pilot project will use a single blind between-subjects randomized design to investigate the effects of non-invasive vagus nerve stimulation (nNVS) on attentional capacities in e-cigarette users. The study will involve administration of self-report surveys regarding vaping dependence and craving, measures of attention, impulsivity, anxiety and negative emotional states, and two quick behavioral tests (reaction time and lexical retrieval) to assess baseline measures of processing speed and executive function. For baseline processing speed assessment, the participants will complete a quick (3-5 min) simple and choice Reaction Time task on a computer prior to the intervention. The lexical retrieval efficiency will be assessed by 1-min Verbal Fluency Test prior to the intervention. Following this, the participants will be randomized to receive either a 2-min nNVS stimulation or control stimulation in the neck region using a portable TruvagaTM Plus device (electroCore). This digital device is a general health and wellness (Digital Health) product and is not intended to diagnose, cure, mitigate, treat, or prevent any disease. The subjects will complete three neuropsychological tests of attention and executive function (Attention Network Test, Symbol Digit Modalities Test, and Verbal Fluency Test) immediately after the intervention. The 1-min Verbal Fluency Test will be completed by the participants both before (pre-test) and after (post-test) the intervention. The specific goals of the study are: 1) To test the hypothesis that e-cigarette users given acute transcutaneous nNVS will perform better on tasks of attention as compared to e-cigarette users given control stimulation. 2): To test the hypothesis that cognitive benefits of nNVS in e-cigarette users will be associated with the degree of nicotine dependence and the magnitude of negative affective states.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Experimental | Device: Active nVNSParticipants 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. |
| Control Stimulation | Experimental | Device: Control nVNSParticipants 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). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy young adults
- Age range 18-25 years
- Current or prior users of e-cigarettes
Key exclusion criteria (20 listed)
- Have any rash, infection, swelling, cut, soreness, drug patch, surgical scar on the neck area
- Have any implantable medical device in their body such as a pacemaker, hearing aid implant, or any other metallic/electronic device
- Have any hearing or vision problems that are not corrected
- Are pregnant or breastfeeding
- Have any learning disabilities
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 |
|---|---|---|
| Active nVNS2-min transcutaneous nVNS stimulation using portable Truvaga Plus Device (electroCore Inc., Rockaway, NJ). | Device | Active Stimulation |
| Control nVNS2-min control stimulation using portable Truvaga Plus Device (electroCore Inc., Rockaway, NJ). | Device | Control Stimulation |
Primary outcome
Efficiency of Attentional Networks using the Attention Network task (ANT)
Time frame: Immediately after intervention
The Attentional Network Task (ANT) measures alerting, orienting, and executive attention that combines spatial cues with different flanker conditions. The efficiency of these three attentional networks is assessed by averaging reaction times and accuracy.
Attention and Processing Speed using the Symbol Digit Modalities Test (SDMT)
Time frame: Immediately after intervention
The Symbol Digit Modalities Test (SDMT) is a sensitive and reliable neuropsychological test for the evaluation of speed of information processing, scanning and tracking aspects of attention, and working memory. SDMT is a simple substitution task that uses a reference key for the participants to pair specific numbers with given geometric figures. The test score is calculated based on the number of correct responses in 90 seconds.
Lexical Retrieval using the Verbal Fluency Task
Time frame: Before and immediately after the intervention.
The Verbal Fluency Task is a neuropsychological measure of lexical retrieval efficiency and executive functioning. In this test, the participants are asked to name the words that starts with a specific alphabet (phonemic fluency) in 60 seconds. The verbal fluency score is calculated based on the number of correct/acceptable words produced within the allotted time.
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 6 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Vaping
Not yet recruitingPhase 1
PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis
Cigarette Smoking-Related Carcinoma
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Active, not recruiting
Mindful Breaths: Mindfulness for Young Adult Vaping
Vaping Cessation
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
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.
Vinay Parikh, PhD principal investigator
Temple University
Jason Chein, PhD principal investigator
Temple University
Tania Giovannetti, PhD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active nVNS in people with Vaping, run by Temple 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 3 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 6 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. 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?
Contact Vinay Parikh, PhD (215-204-1572, vinay.parikh@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency of Attentional Networks using the Attention Network task (ANT) (time frame: Immediately after intervention). The study lists 3 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 6 Mar 2026.