Health TrialsbyHealthPanel

The Effects of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Anxiety Responses and Emotional Regulation

ConditionHealthy Male and Female Volunteers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorUniversity of Electronic Science and Technology of China

About this trial

The main aim of this study is to investigate whether transcutaneous auricular vagus nerve stimulation (taVNS) can reduce anxiety and have an effect on emotional regulations

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy subjects without past or current psychiatric or neurological disorders.

Disqualifiers

History of head injury.

Medical or psychiatric illness.

Subjects take a certain drug for a long period of time.

Subjects have metal implants in their bodies.

Trial design

Design model

Parallel

Treatments tested in this trial

  • taVNS on tragus of subjects with high trait anxiety

    Device

    15 minutes taVNS on tragus

  • taVNS on earlobe of subjects with high trait anxiety

    Device

    15 minutes taVNS on earlobe

  • taVNS on tragus of subjects with no high trait anxiety

    Device

    15 minutes taVNS on tragus

  • taVNS on earlobe of subjects with no high trait anxiety

    Device

    15 minutes taVNS on earlobe

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: Experiment and high trait anxiety groupExperimental treatment 1 intervention
Group B: Sham control and high trait anxiety groupSham comparator 1 intervention
Group C: Experiment and no high trait anxiety groupExperimental treatment 1 intervention
Group D: Sham control and no high trait anxiety groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Brain activity patterns in response to negative pictures during emotional regulation

Subjects will receive task-based fMRI scanning (i.e., the modified emotional regulation task) after taVNS and two resting-state fMRI scanning sessions. We will examine these brain response patterns in the modified emotional regulation task via both the conventional univariate analysis and the machine learning-based multivariate pattern analysis.

Time frame
60 minutes
2

Resting-state functional conetivity changes

Subjects will receive resting-state fMRI scanning twice before and after taVNS. We will examine resting-state functional conetivity changes induced by taVNS via examining functional conetivity differences between pre- and post-taVNS sessions.

Time frame
15 minutes
3

Behavioral indices in the task

Anxiety and success ratings after each regulation trial are recorded in the task. Subjects are instructed to rate their anxiety and success levels using a 9-point Likert scale within 4 seconds (1 = not at all, 9 = very anxious or successful)

Time frame
60 minutes

Secondary outcomes

1

Skin conductance responses (SCR) in the emotional regulation task during fMRI scanning

Skin Conductance Response (SCR) data in response to negative pictures while using different regulation strategies are recorded in the emotional regulation task.

Time frame
60 minutes
2

HRV in resting-state fMRI and emotional regulation task

Heart beat variability (HRV) data are recorded in resting-state fMRI and emotional regulation task.

Time frame
75 minutes during scanning
3

Saliva samples analysis

Saliva samples will be collected three times for subsequent physiological hormone analysis.

Time frame
Three time points: pre-taVNS (baseline, 0 minute), immediate post-taVNS (60 minutes post-taVNS), and the end of experiment (70 minutes post-scanning).

Other outcomes

Sponsors and contacts

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

University of Electronic Science and Technology of China

Lead sponsor

Source ClinicalTrials.gov
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