Non-invasive Vagus Nerve Stimulation (nVNS) and Cognition in Young Adult Vapers - A Pilot Study
nVNS
Vaping and Vagal Neuromodulation of Cognition
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2025
CompletedFirst Posted
Study publicly available on registry
January 31, 2025
CompletedStudy Start
First participant enrolled
March 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 9, 2028
March 6, 2026
March 1, 2026
1.9 years
January 27, 2025
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Before and immediately after the intervention.
Study Arms (2)
Active Stimulation
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
2-min transcutaneous nVNS stimulation using portable Truvaga Plus Device (electroCore Inc., Rockaway, NJ).
2-min control stimulation using portable Truvaga Plus Device (electroCore Inc., Rockaway, NJ).
Eligibility Criteria
You may qualify if:
- Healthy young adults
- Age range 18-25 years
- Current or prior users of e-cigarettes
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Temple University
Philadelphia, Pennsylvania, 19122, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vinay Parikh, PhD
Temple University
- PRINCIPAL INVESTIGATOR
Jason Chein, PhD
Temple University
- PRINCIPAL INVESTIGATOR
Tania Giovannetti, PhD
Temple University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2025
First Posted
January 31, 2025
Study Start
March 18, 2025
Primary Completion (Estimated)
February 9, 2027
Study Completion (Estimated)
February 9, 2028
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share