Clinical trial NCT06804109: Non-invasive Vagus Nerve Stimulation (nVNS) and Cognition in Young Adult Vapers - A Pilot Study
Official title: Vaping and Vagal Neuromodulation of Cognition
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vaping
Keywords: vaping
attention
non-invasive vagus nerve stimulation
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 two cognitive tests of attention.

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 and impulsivity, and measures of anxiety and negative emotional states. 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 two neuropsychological tests of attention (Attention Network Test and Symbol Digit Modalities Test) immediately after 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.

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

Primary outcomes:
measure: Efficiency of Attentional Networks using the Attention Network task (ANT)
timeFrame: Immediately after intervention
measure: Attention and Processing Speed using the Symbol Digit Modalities Test (SDMT)
timeFrame: Immediately after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Vinay Parikh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University
name: Jason Chein, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University
name: Tania Giovannetti, PhD
role: PRINCIPAL_INVESTIGATOR
References: