Examining Transcutaneous Vagal Nerve Stimulation as a Facilitator of Social Bonding

NCT05899413 | Completed Results

• 2 other identifiers: 23-39189U24AG072699
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (4)

• Self-reported Positive Affect

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

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

• Self-reported Negative Affect

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

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

• Respiratory Sinus Arrhythmia

  RSA was assessed continuously throughout the conversation.

  Continuously throughout conflict conversation

• Interbeat Interval

  IBI was assessed continuously throughout the conversation.

  Continuously throughout the conflict conversation

Study Arms (2)

Active tVNS

EXPERIMENTAL

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.

Device: Transcutaneous vagal nerve stimulation

Sham tVNS

SHAM COMPARATOR

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.

Device: Transcutaneous vagal nerve stimulation

Interventions

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.

Active tVNS; Sham tVNS

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UCSF Nancy Friend Pritzker Psychiatry Building

San Francisco, California, 94107, United States

Location

Related Publications (1)

• 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.

  BACKGROUND

Results Point of Contact

• Title: Dr. Yoobin Park
• Organization: University of California, San Francisco

yoobin.park@ucsf.edu

6289461325

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant couples will be blinded to their condition. Experimenters running the study will not be blinded since tVNS administration currently requires their knowledge of the condition.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Couple dyads will be randomly assigned to receive either tVNS or sham stimulation.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 12, 2023
• Study Start: February 17, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: May 4, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)