Recruiting

nNVSNon-invasive Vagus Nerve Stimulation (nVNS) and Cognition in Young Adult Vapers - A Pilot Study

Sponsor:

Temple University

Code:

NCT06804109

Conditions

Vaping

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

Interventions

Active nVNS

Control nVNS

Study Details

Brief 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. 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.

Conditions

Vaping

Study ID

NCT06804109

Start date

Mar 18, 2025

Status verified date

Mar, 2026

Completion date

Feb 9, 2028

Anticipated

Primary completion date

Feb 9, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

Inclusion Criteria:

Healthy young adults
Age range 18-25 years
Current or prior users of e-cigarettes

Exclusion Criteria:

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
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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Active Stimulation

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.

experimental: Control Stimulation

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).

Interventions

Active nVNS

2-min transcutaneous nVNS stimulation using portable Truvaga Plus Device (electroCore Inc., Rockaway, NJ).

Control nVNS

2-min control stimulation using portable Truvaga Plus Device (electroCore Inc., Rockaway, NJ).

Primary outcome measure

Efficiency of Attentional Networks using the Attention Network task (ANT) [ Time Frame: Immediately after intervention ]
Attention and Processing Speed using the Symbol Digit Modalities Test (SDMT) [ Time Frame: Immediately after intervention ]
Lexical Retrieval using the Verbal Fluency Task [ Time Frame: Before and immediately after the intervention. ]

Central Contacts and Locations

Central contacts

Vinay Parikh, PhD

215-204-1572 vinay.parikh@temple.edu

Locations

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19122

More Information

Sponsor

Temple University

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

vaping
attention
non-invasive vagus nerve stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Temple University on 2026-03-06.