Healthy ParticipantsPhase 1NCT06975124
taVNS Effects on Fear Ratings in Naturalistic Context
A Phase 1 study testing transcutaneous auricular vagus nerve stimulation in people with Healthy Participants, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
During the fear rating task, 70 participants viewed a 600-second horror movie while continuously rating their subjective fear intensity (0-100 scale) every 0.51 seconds (1,170 total ratings). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Jul 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants without color blindness, current or regular substance or medication use, any current or history of medical or psychiatric disorders and contraindications for MRI.
Who cannot join
- Color blindness,
- Current or regular substance or medication use
- any current or history of medical or psychiatric disorders and contraindications for MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nirsit Lite
Chengdu, Sichuan, 611731
Weihua Zhao, Phd, +86 18780247797, zarazhao@uestc.edu.cn
Weihua Zhao, PhD
About this study
During the fear rating task, 70 participants viewed a 600-second horror movie while continuously rating their subjective fear intensity (0-100 scale) every 0.51 seconds (1,170 total ratings). Functional near-infrared spectroscopy (fNIRS) data were simultaneously recorded using the NIRSIT LITE system to monitor cortical hemodynamic responses.
Read the detailed description
In a sham-controlled, participant-blinded, between-subjects design, 70 participants were randomly assigned to either active transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation. The taVNS group received stimulation via a modified transcutaneous electrical acupoint stimulation device, with ear clip electrodes attached to the left cymba conchae to target vagus nerve branches. The sham group received identical electrode placement on the left earlobe, a non-vagus-innervated site. Stimulation intensity was individually calibrated to a perceptible but non-painful level to ensure vagal activation while maintaining participant comfort.
Upon arrival, all participants completed standardized mood and trait questionnaires. To assess emotional and physiological changes, two administrations of the Positive and Negative Affect Schedule (PANAS) and blood pressure/pulse measurements (pre- and post-intervention) were conducted. During the fear rating task, participants viewed a 600-second horror movie while continuously rating their subjective fear intensity (0-100 scale) every 0.51 seconds (1,170 total ratings). Functional near-infrared spectroscopy (fNIRS) data were simultaneously recorded using the NIRSIT LITE system to monitor cortical hemodynamic responses. Additionally, skin conductance responses were measured vy BIOPAC MP150 system.
- Conditions
- Healthy Participants
- Being tested
- transcutaneous auricular vagus nerve stimulation, Sham condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous auricular vagus nerve stimulationDevice
Ear clip electrodes attached to the left cymba conchae to target vagus nerve branches.
Sham conditionDevice
Electrode placement attached on the left earlobe.
| Study group | Role | What they receive |
|---|---|---|
| taVNS group | Active comparator | Eear clip electrodes were attached to the left cymba conchae to target vagus nerve branches. Receives: Device: transcutaneous auricular vagus nerve stimulation |
| Sham group | Sham comparator | Electrode placements were attached on the left earlobe Receives: Device: Sham condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural activity changes between groups
The differences in the activity of frontal regions between groups using fNIRS
Measured: 10 minutes
Fear ratings between groups
The differences in the fear ratings (0-100, from neutral to extremely fearful) between groups
Measured: 10 minutes
Functional connectivity witnin frontal regions between groups
The differences in the functional connectivity within frontal regions using fNIRS between groups
Measured: 10 minutes
The correlation between brain activity and behavioral ratings across groups
The correlation between brain activity and behavioral ratings across groups
Measured: 10 minutes
Secondary outcomes (1)
Skin conductance response between groups
The differences in the skin conductance response during watching video between groups
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Mar 2025
- Primary completion1 Jun 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- 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
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weihua Zhao, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975124
- Sponsor's protocol ID
- UESTC-neuSCAN-100
- Status last verified
- May 2025
- First submitted
- 23 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- taVNS Effects on Fear Ratings in Naturalistic Context
- ClinicalTrials.gov ID
- NCT06975124
- Acronym / sponsor ID
- UESTC-neuSCAN-100
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During the fear rating task, 70 participants viewed a 600-second horror movie while continuously rating their subjective fear intensity (0-100 scale) every 0.51 seconds (1,170 total ratings). Functional near-infrared spectroscopy (fNIRS) data were simultaneously recorded using the NIRSIT LITE system to monitor cortical hemodynamic responses.
Detailed description
In a sham-controlled, participant-blinded, between-subjects design, 70 participants were randomly assigned to either active transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation. The taVNS group received stimulation via a modified transcutaneous electrical acupoint stimulation device, with ear clip electrodes attached to the left cymba conchae to target vagus nerve branches. The sham group received identical electrode placement on the left earlobe, a non-vagus-innervated site. Stimulation intensity was individually calibrated to a perceptible but non-painful level to ensure vagal activation while maintaining participant comfort.
Upon arrival, all participants completed standardized mood and trait questionnaires. To assess emotional and physiological changes, two administrations of the Positive and Negative Affect Schedule (PANAS) and blood pressure/pulse measurements (pre- and post-intervention) were conducted. During the fear rating task, participants viewed a 600-second horror movie while continuously rating their subjective fear intensity (0-100 scale) every 0.51 seconds (1,170 total ratings). Functional near-infrared spectroscopy (fNIRS) data were simultaneously recorded using the NIRSIT LITE system to monitor cortical hemodynamic responses. Additionally, skin conductance responses were measured vy BIOPAC MP150 system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS group | Active comparator | Device: transcutaneous auricular vagus nerve stimulationEear clip electrodes were attached to the left cymba conchae to target vagus nerve branches. |
| Sham group | Sham comparator | Device: Sham conditionElectrode placements were attached on the left earlobe |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy participants without color blindness, current or regular substance or medication use, any current or history of medical or psychiatric disorders and contraindications for MRI.
Key exclusion criteria (3 listed)
- Color blindness,
- Current or regular substance or medication use
- any current or history of medical or psychiatric disorders and contraindications for MRI
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 auricular vagus nerve stimulationEar clip electrodes attached to the left cymba conchae to target vagus nerve branches. | Device | taVNS group |
| Sham conditionElectrode placement attached on the left earlobe. | Device | Sham group |
Primary outcome
Neural activity changes between groups
Time frame: 10 minutes
The differences in the activity of frontal regions between groups using fNIRS
Fear ratings between groups
Time frame: 10 minutes
The differences in the fear ratings (0-100, from neutral to extremely fearful) between groups
Functional connectivity witnin frontal regions between groups
Time frame: 10 minutes
The differences in the functional connectivity within frontal regions using fNIRS between groups
The correlation between brain activity and behavioral ratings across groups
Time frame: 10 minutes
The correlation between brain activity and behavioral ratings across groups
1 secondary outcome
Skin conductance response between groups
Time frame: 10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing transcutaneous auricular vagus nerve stimulation in people with Healthy Participants, run by University of Electronic Science and Technology of China at 1 site in China.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 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 China. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural activity changes between groups (time frame: 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?
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 16 May 2025.