Examining Transcutaneous Vagal Nerve Stimulation as a Facilitator of Social Bonding (CtVNS)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Vagus Nerve Stimulation

Treatments: Device: Transcutaneous vagal nerve stimulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05899413

23-39189

U24AG072699

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Active tVNS

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous vagal nerve stimulation

Sham tVNS

Sham Comparator group

Description:

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.

Treatment:

Device: Transcutaneous vagal nerve stimulation