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Completed

NCT Number: NCT05899413

Examining Transcutaneous Vagal Nerve Stimulation as a Facilitator of Social Bonding

This study aims to understand the role of the vagus nerve in promoting social bonding by using a non-invasive stimulation technique called transcutaneous vagal nerve stimulation (tVNS). The investigators will investigate whether tVNS can improve emotional, physiological, and behavioral experiences during and after social interactions. Couples will be randomly assigned to receive either tVNS or a sham stimulation during gratitude expression and problem-solving discussions. The investigators will measure their subjective evaluations of the interactions and capture their physiological and behavioral synchrony. This research will shed light on the processes involved in social connection and explore the potential of tVNS as a tool to enhance bonding in close relationships.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Primary location

UCSF Nancy Friend Pritzker Psychiatry Building

San Francisco, California, 94107, United States

About this study

As fundamental as the need to belong is to human survival and functioning, decades of research have shown that social connection is critical to emotional well-being. The current investigation seeks to use the knowledge and technological advances in the biomedical field to examine the causal role of the vagus nerve in promoting social bonding. Specifically, building on the recent evidence suggesting the effects of transcutaneous vagal nerve stimulation (tVNS) on improving social cognitive functioning, this study will examine the utility of tVNS in modulating emotional, physiological, and behavioral experiences during and after social interactions. The investigators will examine if romantic couple assigned to receive tVNS vs. active sham stimulation during two types of conversations (i.e., gratitude expression and problem-solving discussion) show differences in their experiences of the interactions. The study outcomes will include subjective evaluations of the interaction (e.g., felt emotions) and their physiological synchrony. This investigation will provide insights into the mechanistic processes that undergird social connection and, importantly, be the first to examine the potential utility of tVNS as an intervention tool for promoting social bonding within close relationships.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fluent in English
  • Having been in a relationship with the partner for at least a year
  • Within the age range of 18-39

Exclusion criteria

  • Major chronic disease. self-reported autoimmune disease; severe asthma; lung disease (such as chronic bronchitis; history of stroke, heart attack, epilepsy, brain injury); cardiovascular disease.
  • Cancer: if not in remission.
  • Substance dependence-current or long history (5 years of more).
  • Current psychiatric diagnosis that is not being treated with medication
  • Confounding medications, including those used to treat hypertension and cardiovascular conditions; psychoactive substances; and medications known to directly affect autonomic functioning.

Treatment and study plan

transcutaneous vagal nerve stimulation

Device

The intervention consists of neurostimulation device that is programmed to a stimulus intensity at 0.5mA with a stimulation frequency of 25 Hz at the outer auditory canal.

Primary outcomes

  1. Self-reported Positive Affect

    Time frame: Once, self-reported in a survey immediately following conflict interaction, up to 10 minutes

    During the conversation, overall, I felt… (1: not at all positive, 7: extremely positive)

  2. Self-reported Negative Affect

    Time frame: Once, self-reported in a survey immediately following conflict interaction, up to 10 minutes

    During the conversation, overall, I felt… (1: not at all negative, 7: extremely negative)

  3. Respiratory Sinus Arrhythmia

    Time frame: Continuously throughout conflict conversation

    RSA was assessed continuously throughout the conversation.

  4. Interbeat Interval

    Time frame: Continuously throughout the conflict conversation

    IBI was assessed continuously throughout the conversation.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: CtVNS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 12, 2023
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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