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

NCT ID: NCT06804109

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-18
• Study Completion Date: 2028-02-09

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Active nVNS

Intervention Type: DEVICE

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

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).

Group Type: EXPERIMENTAL

Control nVNS

Intervention Type: DEVICE

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

Interventions

Active nVNS

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

Intervention Type: DEVICE

Control nVNS

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vinay Parikh, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Jason Chein, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Tania Giovannetti, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

Temple University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vinay Parikh, PhD

Role: CONTACT

vinay.parikh@temple.edu

215-204-1572

Other Identifiers

IRB31783

Identifier Type: -

Identifier Source: org_study_id