Examining Transcutaneous Vagal Nerve Stimulation as a Facilitator of Social Bonding

NCT ID: NCT05899413

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-17
• Study Completion Date: 2024-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Vagus Nerve Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Active tVNS

We will use a research edition of an auricular vagus nerve stimulator (tVNS RE, Vagus.net™, UK) that sends current-controlled stimulation in symmetric biphasic waveforms. The tVNS RE conforms to EU directive 93/42/EEC medical device standards and ISO/IEC 17050-1. This device consists of a handheld stimulator and an electrode clip. We will deliver stimulation at the individually calibrated intensity continuously during the interactions, and the default device settings we adopted were as follows: frequency = 30Hz, phase duration = 250μs, interphase interval = 50μs, and max voltage = 65V. In the active stimulation condition, both partners will have the stimulation clip attached to the outer auditory canal.

Group Type: EXPERIMENTAL

Transcutaneous vagal nerve stimulation

Intervention Type: 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.

Sham tVNS

In the sham condition, both partners will have electrodes attached to the center of the left ear lobe. They will still receive stimulation but at a placement that should not activate the vagus nerve.

Group Type: SHAM_COMPARATOR

Transcutaneous vagal nerve stimulation

Intervention Type: 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.

Interventions

Transcutaneous vagal nerve stimulation

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UCSF Nancy Friend Pritzker Psychiatry Building

San Francisco, California, United States

Countries

United States

References

Chung JM, Harari GM, Denissen JJ. Investigating the within-person structure and correlates of emotional experiences in everyday life using an emotion family approach. Journal of Personality and Social Psychology. 2022;122(6):1146-1189.

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U24AG072699

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-39189

Identifier Type: -

Identifier Source: org_study_id