Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Cognitive Performance and Sex Differences

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorBahçeşehir University

About this trial

This study investigates the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on cognitive performance in healthy adults. The study uses a sham-controlled, cross-over design in which each participant receives both active taVNS and sham stimulation in separate sessions. Each participant completes both conditions (active and sham) in a randomized order using a crossover design. Cognitive performance will be assessed before and after each session using standardized tests. The study also explores whether males and females respond differently to taVNS, in order to identify potential sex-related differences in cognitive outcomes.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy young adults aged 18-30 years

Ability to provide informed consent

Right-handed participants (to reduce variability in cognitive performance)

Normal or corrected-to-normal vision and hearing

Disqualifiers

History of neurological or psychiatric disorders

Cardiovascular disease

Use of psychoactive medications

Substance dependence, including alcohol, illicit drugs, or nicotine

Trial design

Design model

Crossover

Treatments tested in this trial

  • Active taVNS

    Device

    Active taVNS will be delivered bilaterally to the cymba conchae and tragus regions using the VaguStim device. Stimulation parameters follow cognitive-neuroscience standards to minimize cardiac side effects: biphasic waveform, 25 Hz frequency, 250 μs pulse width, and intensity individually adjusted below the sensory threshold (0.5-4 mA). Each stimulation session lasts 20 minutes. This intervention corresponds to the Active taVNS Stimulation arm.

  • Sham Stimulation

    Device

    Sham stimulation will be delivered using the same VaguStim device, but electrodes will be placed bilaterally on the earlobe, an area not innervated by the vagus nerve. Device parameters will be set to match the active condition, but no true vagus nerve stimulation is delivered. This procedure controls for placebo and participant expectancy effects. This intervention corresponds to the Sham Stimulation arm.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Active taVNS StimulationExperimental treatment 1 intervention
Group B: Sham StimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

CogniFit Digital Battery

Cognitive performance will be evaluated using the CogniFit digital cognitive battery, which assesses multiple cognitive domains including attention, working memory, executive functions, and processing speed. The battery will be administered once at baseline (Visit 1). It will be administered again immediately after Active stimulation in Visit 2 and immediately after Sham stimulation in Visit 3. Changes in cognitive scores between baseline and post-stimulation sessions will be compared to determine the acute cognitive effects of active vs. sham taVNS.

Time frame
Day 1 (Visit 1 baseline), Day 8 (Visit 2), and Day 15 (Visit 3) Cognitive testing will occur after stimulation on Day 8 and Day 15.

Secondary outcomes

1

Heart Rate Variability (HRV)

Heart rate variability will be assessed using the Polar H10 chest strap or another validated portable HRV device widely used in research. Five-minute recordings will be obtained during resting state and during stimulation. Time-domain parameters (RMSSD, SDNN) and frequency-domain parameters (LF/HF ratio) will be analyzed.

Time frame
Day 8 (Visit 2): 5 minutes before stimulation and 5 minutes after stimulation. Day 15 (Visit 3): 5 minutes before stimulation and 5 minutes after stimulation.
2

Perceived Stress Levels (PSS)

The Perceived Stress Scale (PSS) will assess participants' perceived stress levels over the past month. Higher scores indicate higher perceived stress.

Time frame
Day 1 (Visit 1 baseline), Day 8 (Visit 2 after stimulation), and Day 15 (Visit 3 after stimulation).
3

State and Trait Anxiety (STAI)

The State-Trait Anxiety Inventory (STAI) will measure acute state anxiety (STAI-S) and general trait anxiety (STAI-T).

Time frame
Day 1 (Visit 1 baseline), Day 8 (Visit 2 after stimulation), and Day 15 (Visit 3 after stimulation).
4

Self-Reported Side Effects

A researcher-developed side-effects questionnaire will be used to record any discomfort, tingling, dizziness, or other adverse effects following stimulation.

Time frame
Day 8 (Visit 2 after stimulation) and Day 15 (Visit 3 after stimulation)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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