Health TrialsbyHealthPanel

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

ConditionVaping
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorTemple University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy young adults

Age range 18-25 years

Current or prior users of e-cigarettes

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active nVNS

    Device

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

  • Control nVNS

    Device

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Active StimulationExperimental treatment 1 intervention
Group B: Control StimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Immediately after intervention
2

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.

Time frame
Immediately after intervention
3

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.

Time frame
Before and immediately after the intervention.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Temple University

Lead sponsor

Source ClinicalTrials.gov
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