Pain ManagementNCT07719868
TaVNS for Capsaicin-Induced Pain
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Pain Management and Capsaicin-Induced Pain, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Effective pain management remains a major clinical challenge. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a promising, non-invasive neuromodulation technique due to its safety, ease of administration, and cost-effectiveness. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Capsaicin-Induced Pain, Transcranial Magnetic Stimulation Repetitive
- 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
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2026to 10 Sep 2027
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Adults aged 18 to 65 years. 2. Physically and mentally healthy individuals with no history of chronic pain (confirmed via clinical interviews and the MINI International Neuropsychiatric Interview).
- 3. Right-handed.
Who cannot join
- 1. Presence of metallic implants (e.g., cardiac pacemakers) or other conditions precluding vagus nerve stimulation.
- 2. Diagnosis of psychiatric disorders or presence of suicidal ideation. 3. History of epilepsy. 4. History of drug or substance abuse/dependence. 5. Known allergy to capsaicin or its vehicle solutions. 6. Inability to understand or respond to study-related questions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Analgesic Efficacy and Neural Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in a Capsaicin-Induced Pain Model
Effective pain management remains a major clinical challenge. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a promising, non-invasive neuromodulation technique due to its safety, ease of administration, and cost-effectiveness. Preliminary evidence suggests that taVNS exerts analgesic effects by activating afferent vagal fibers, which integrate signals in key central nodes such as the nucleus tractus solitarius (NTS). This process subsequently modulates pain-processing networks, neurotransmitter balance, inflammatory responses, and autonomic function.
Despite its potential, the precise central neural mechanisms underlying taVNS-induced analgesia remain unclear, limiting the optimization of stimulation parameters (e.g., intensity, frequency, and target specificity) and the enhancement of long-term therapeutic outcomes. Previous studies have highlighted the role of taVNS in activating descending pain inhibitory pathways and modulating the limbic system, yet a comprehensive understanding of the causal neurophysiological dynamics is still lacking.
This study aims to investigate the analgesic efficacy of taVNS using a capsaicin-induced pain model. Furthermore, by employing Transcranial Magnetic Stimulation combined with Electroencephalography (TMS-EEG), we seek to elucidate the central neural mechanisms of taVNS. By integrating causal intervention with high-temporal resolution brain activity recording, this research will provide scientific insights into the modulation of pain-related pathways-such as descending inhibitory and cognitive-affective networks-ultimately facilitating the development of standardized, individualized, and precise clinical interventions for pain management.
- Conditions
- Pain Management, Capsaicin-Induced Pain, Transcranial Magnetic Stimulation Repetitive, Electroencephalography, Vagus Nerve Stimulation, Neuromodulation
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve StimulationDevice
Participants receive taVNS using a percutaneous electrical stimulation device. The stimulation is delivered to the auricular branch of the vagus nerve via two modified punctate electrodes with the following parameters: frequency = 30 Hz, pulse width = 200 μs, duration = 30 minutes.
Transcutaneous Auricular Vagus Nerve StimulationDevice
Participants receive sham stimulation via the same device, with parameters set to 0.1 Hz for 30 minutes, designed to provide minimal sensory input that is indistinguishable from the active stimulation to ensure double-blinding.
| Study group | Role | What they receive |
|---|---|---|
| Active taVNS | Active comparator | Not described Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| Sham taVNS | Sham comparator | Not described Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Measured using the Visual Analog Scale (VAS).
Measured: Baseline and every 10 minutes up to 90 minutes post-capsaicin application.
Secondary outcomes (4)
Neural Plasticity and Brain Activity
Assessed via TMS-EEG (Transcranial Magnetic Stimulation combined with Electroencephalography), including TMS-Evoked Potentials (TEPs) (e.g., N40, P60, N100, P200), neural oscillations, and global field power.
Measured: Baseline (pre-intervention), 40 minutes, and 90 minutes post-capsaicin application.
Brain Network Connectivity
Assessed via weighted phase lag index (wPLI) based on EEG data to evaluate whole-brain network connectivity changes.
Measured: Baseline (pre-intervention), 40 minutes, and 90 minutes post-capsaicin application.
Pain-Related Emotional States
Assessed using a standardized pain-related emotional scale to evaluate changes in emotional state following the intervention.
Measured: From baseline through 90 minutes post-capsaicin application, assessed every 10 minutes.
Pain-Related Cognitive States
Assessed using a standardized pain-related cognitive scale to evaluate changes in cognitive processing following the intervention.
Measured: At baseline, 40 minutes post-capsaicin, and 90 minutes post-capsaicin.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion10 Jul 2027 (estimated)
- Study completion10 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yu lina, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719868
- Sponsor's protocol ID
- 2025-1505
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 22 Jul 2026
- 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy and Neural Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in a Capsaicin-Induced Pain Model
- ClinicalTrials.gov ID
- NCT07719868
- Acronym / sponsor ID
- 2025-1505
- Conditions
- Pain Management, Capsaicin-Induced Pain, Transcranial Magnetic Stimulation Repetitive, Electroencephalography, Vagus Nerve Stimulation, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 10 Jul 2027 (estimated)
- Study completion
- 10 Sep 2027 (estimated)
- First posted
- 22 Jul 2026 (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.
Effective pain management remains a major clinical challenge. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a promising, non-invasive neuromodulation technique due to its safety, ease of administration, and cost-effectiveness. Preliminary evidence suggests that taVNS exerts analgesic effects by activating afferent vagal fibers, which integrate signals in key central nodes such as the nucleus tractus solitarius (NTS). This process subsequently modulates pain-processing networks, neurotransmitter balance, inflammatory responses, and autonomic function.
Despite its potential, the precise central neural mechanisms underlying taVNS-induced analgesia remain unclear, limiting the optimization of stimulation parameters (e.g., intensity, frequency, and target specificity) and the enhancement of long-term therapeutic outcomes. Previous studies have highlighted the role of taVNS in activating descending pain inhibitory pathways and modulating the limbic system, yet a comprehensive understanding of the causal neurophysiological dynamics is still lacking.
This study aims to investigate the analgesic efficacy of taVNS using a capsaicin-induced pain model. Furthermore, by employing Transcranial Magnetic Stimulation combined with Electroencephalography (TMS-EEG), we seek to elucidate the central neural mechanisms of taVNS. By integrating causal intervention with high-temporal resolution brain activity recording, this research will provide scientific insights into the modulation of pain-related pathways-such as descending inhibitory and cognitive-affective networks-ultimately facilitating the development of standardized, individualized, and precise clinical interventions for pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active taVNS | Active comparator | Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| Sham taVNS | Sham comparator | Device: Transcutaneous Auricular Vagus Nerve Stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Adults aged 18 to 65 years. 2. Physically and mentally healthy individuals with no history of chronic pain (confirmed via clinical interviews and the MINI International Neuropsychiatric Interview).
- 3. Right-handed.
Key exclusion criteria (2 listed)
- 1. Presence of metallic implants (e.g., cardiac pacemakers) or other conditions precluding vagus nerve stimulation.
- 2. Diagnosis of psychiatric disorders or presence of suicidal ideation. 3. History of epilepsy. 4. History of drug or substance abuse/dependence. 5. Known allergy to capsaicin or its vehicle solutions. 6. Inability to understand or respond to study-related questions.
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 StimulationParticipants receive taVNS using a percutaneous electrical stimulation device. The stimulation is delivered to the auricular branch of the vagus nerve via two modified punctate electrodes with the following parameters: frequency = 30 Hz, pulse width = 200 μs, duration = 30 minutes. | Device | Active taVNS |
| Transcutaneous Auricular Vagus Nerve StimulationParticipants receive sham stimulation via the same device, with parameters set to 0.1 Hz for 30 minutes, designed to provide minimal sensory input that is indistinguishable from the active stimulation to ensure double-blinding. | Device | Sham taVNS |
Primary outcome
Pain Intensity
Time frame: Baseline and every 10 minutes up to 90 minutes post-capsaicin application.
Measured using the Visual Analog Scale (VAS).
4 secondary outcomes
Neural Plasticity and Brain Activity
Time frame: Baseline (pre-intervention), 40 minutes, and 90 minutes post-capsaicin application.
Brain Network Connectivity
Time frame: Baseline (pre-intervention), 40 minutes, and 90 minutes post-capsaicin application.
Pain-Related Emotional States
Time frame: From baseline through 90 minutes post-capsaicin application, assessed every 10 minutes.
Pain-Related Cognitive States
Time frame: At baseline, 40 minutes post-capsaicin, and 90 minutes post-capsaicin.
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 22 Jul 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Pain Management and Capsaicin-Induced Pain, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Contact Lina Yu, M.D. (8613958033387, zryulina@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Baseline and every 10 minutes up to 90 minutes post-capsaicin application.). 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 22 Jul 2026.