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

University of Electronic Science and Technology of China

Status: Enrolling

Conditions: Healthy Male and Female Volunteers

Treatments: Device: taVNS on tragus of subjects with no high trait anxiety; Device: taVNS on earlobe of subjects with no high trait anxiety; Device: taVNS on earlobe of subjects with high trait anxiety; Device: taVNS on tragus of subjects with high trait anxiety

Study type: Interventional

Funder types: Other

Identifiers

NCT07369908

UESTC-neuSCAN-97

Details and patient eligibility

About

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

Full description

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive method for modulating vagal nerve function and has shown potential efficacy in alleviating anxiety symptoms and improving emotional regulation. But the neural mechanisms of how taVNS affects anxiety and emotional regulation remain unclear. Therefore, we focus on this question by combining behavioral meausres, skin conductance response, heart rate variability and fMRI in this study. A participant-blinded, sham-controlled, between-subject design is employed in this study. In a randomised order, a total of 140 healthy males and females with or without high trait anxiety are recruited and receive the stimulation of taVNS on their tragus (experimental group) or earlobe (sham control group). After the participants arrive at the laboratory, they first complete a roughly 30-minute personality trait questionnaire and prepare for the experiment. Then, they undergo a 7-minute resting-state fMRI scan, followed by a 15-minute taVNS session. Next, they complete a 7-minute resting-state scan and a 60-minute task-based scan (a modified emotional regulation task). During the entire procedure, saliva samples will be collected three times for subsequent physiological hormone analyses, and participants' skin conductance and electrocardiogram data will also be recorded. During the modified emotional regulation task, subjects are instructed to regulate their emotional responses to negative pictures (high vs. low intensity) using reinterpretation/distance strategies or to only look these pictures. We also record subjects' rating scores on their anxiety levels during these conditions ("reinterpretation" vs. "distance" vs. "look") and successful usage of emotional regulation strategies. Questionnaire scores including State-Trait Anxiety Inventory, Beck Depression Inventory II, Beck Anxiety Inventory, Autism Spectrum Quotient, Toronto Alexithymia Scale, Social Responsiveness Scale, Emotion Regulation Questionnaire, Cognitive Emotion Regulation Questionnaire, Multidimensional Assessment of Interoceptive Awareness, Positive and Negative Affect Schedule will also be collected.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects without past or current psychiatric or neurological disorders.

Exclusion criteria

• 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

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 4 patient groups

Experiment and high trait anxiety group

Experimental group

Description:

male and female subjects with high trait anxiety and experimental treatment

Treatment:

Device: taVNS on tragus of subjects with high trait anxiety

Sham control and high trait anxiety group

Sham Comparator group

Description:

male and female subjects with high trait anxiety and sham treatment

Treatment:

Device: taVNS on earlobe of subjects with high trait anxiety

Experiment and no high trait anxiety group

Experimental group

Description:

male and female subjects with no high trait anxiety and experimental treatment

Treatment:

Device: taVNS on tragus of subjects with no high trait anxiety

Sham control and no high trait anxiety group

Sham Comparator group

Description:

male and female subjects with no high trait anxiety and sham treatment

Treatment:

Device: taVNS on earlobe of subjects with no high trait anxiety