Vagus Nerve StimulationCtVNSNCT05899413
Examining Transcutaneous Vagal Nerve Stimulation as a Facilitator of Social Bonding
A study testing Transcutaneous vagal nerve stimulation in people with Vagus Nerve Stimulation, run by University of California, San Francisco at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Vagus Nerve Stimulation
- What is being tested?
- Transcutaneous vagal nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2024to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fluent in English
- Having been in a relationship with the partner for at least a year
- Within the age range of 18-39
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
UCSF Nancy Friend Pritzker Psychiatry Building
San Francisco, California, 94107
About this study
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.
Read the 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
- Being tested
- Transcutaneous vagal nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous vagal nerve stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcutaneous vagal nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Positive Affect
During the conversation, overall, I felt… (1: not at all positive, 7: extremely positive)
Measured: 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)
Measured: Once, self-reported in a survey immediately following conflict interaction, up to 10 minutes
Respiratory Sinus Arrhythmia
RSA was assessed continuously throughout the conversation.
Measured: Continuously throughout conflict conversation
Interbeat Interval
IBI was assessed continuously throughout the conversation.
Measured: Continuously throughout the conflict conversation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start17 Feb 2024
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vagus Nerve StimulationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Couple dyads will be randomly assigned to receive either tVNS or sham stimulation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899413
- Sponsor's protocol ID
- 23-39189
- Other IDs
- U24AG072699
- Acronym
- CtVNS
- Status last verified
- Apr 2025
- First submitted
- 24 May 2023
- Last updated
- 4 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: There is currently no plan to make individual participant data available to other researchers.
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Transcutaneous Vagal Nerve Stimulation as a Facilitator of Social Bonding
- ClinicalTrials.gov ID
- NCT05899413
- Acronym / sponsor ID
- CtVNS / 23-39189
- Conditions
- Vagus Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 17 Feb 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Posted 4 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Couple dyads will be randomly assigned to receive either tVNS or sham stimulation.
| Arm | Type | Receives |
|---|---|---|
| Active tVNS | Experimental | Device: Transcutaneous vagal nerve stimulationWe 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. |
| Sham tVNS | Sham comparator | Device: Transcutaneous vagal nerve stimulationIn 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fluent in English
- Having been in a relationship with the partner for at least a year
- Within the age range of 18-39
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous vagal nerve stimulationThe 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. | Device | Active tVNS, Sham tVNS |
Primary outcome
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)
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)
Respiratory Sinus Arrhythmia
Time frame: Continuously throughout conflict conversation
RSA was assessed continuously throughout the conversation.
Interbeat Interval
Time frame: Continuously throughout the conflict conversation
IBI was assessed continuously throughout the conversation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundChung 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.
- Individual participant dataSharing planned: No. There is currently no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous vagal nerve stimulation in people with Vagus Nerve Stimulation, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Positive Affect (time frame: Once, self-reported in a survey immediately following conflict interaction, up to 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05899413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.