Dysmenorrhea PrimarytaVNS-DYSMNCT06912386
Pain Relief From Dysmenorrhea Employing taVNS
A study testing taVNS in people with Dysmenorrhea Primary, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
The goal of this clinical trial is to determine if transauricular vagal nerve stimulation (taVNS) is effective in treating moderate dysmenorrhea. The main question it aims to answer is: Does taVNS reduce the number of times participants suffering from dysmenorrhea need to use rescue medication during menstruation?… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 30 Jun 2025
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Regular menstrual cycle (28 days ± 7 days);
- Average moderate menstrual pain (with 4 - 7 NRS scores);
- History of over-the-counter (OTC) analgesic use for the treatment of menstrual pain (at least 1 IBUPROFEN for the first two days);
- 4 consecutive monthly menstrual cycles;
- Non-pregnant status;
- Agrees to use adequate birth control during the trial;
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- Otherwise, healthy;
- Agree not to participate in any other clinical trial while enrolled in this trial ;
- No facial or ear pain, no recent ear trauma, no metal implants including pacemakers;
- Normal ECG, Heart Rate and Blood Pressure (systolic BP 105-130, diastolic BP 60-90, heart rate per min at rest 60-85);
Who cannot join
- Currently under medications (except for analgesic medication for menstrual cycle);
- Use of oral contraceptive;
- Secondary cause for dysmenorrhea (i.e., endometriosis, adenomyosis, uterine fibroids, or infection);
- Unstable or serious illness (e.g., kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, lung conditions, chronic asthma, diagnosed psychological or mood disorder, hypertension, any bleeding disorders, recent surgery, or concurrent blood thinning treatment);
- Current malignancy or treatment for malignancy within the previous 2 years;
- Pregnant or lactating women;
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- Active smokers, nicotine use, or drug (prescription or illegal substances) abuse;
- Chronic past and/or current alcohol use (>14 alcoholic drinks per week);
- Any condition that in the opinion of the investigator, makes the participant unsuitable for inclusion;
- Unwilling or unable to comply with protocol;
- Active genitourinary infection in the last four weeks;
- Unable to read or comprehend the informed consent;
- Unwilling to complete study procedures;
- Participated in any other clinical trial during the past 1 month;
- Personal or family history of seizure, mood, or cardiovascular disorders;
- Allergic reaction to surface electrodes.
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
UESTC
Chengdu, Sichuan, 611731
stefania Ferraro, PhD, stefania@uestc.edu.cn
About this study
Official title: A Randomized Two-Way Crossover Comparison Study of Pain Relief From Dysmenorrhea Employing taVNS and Sham Stimulation
The goal of this clinical trial is to determine if transauricular vagal nerve stimulation (taVNS) is effective in treating moderate dysmenorrhea. The main question it aims to answer is:
- Does taVNS reduce the number of times participants suffering from dysmenorrhea need to use rescue medication during menstruation? Researchers will compare taVNS stimulation with a sham stimulation (a look-alike procedure that does not stimulate the vagus nerve) to assess whether taVNS is effective in treating moderate dysmenorrhea.
Read more
Participants will:
- Undergo taVNS for 2 months and sham stimulation for another 2 months, each for 5 days per month, starting 2 days before the expected beginning of their menstrual cycle.
- Visit the clinic twice a month for checkups and tests.
- Keep a diary to record their pain levels and the number of times they use rescue medication.
- Undergo functional magnetic resonance imagine two times (one after the end of the first use of taVNS and another after the end of the first use of SHAM stimulation).
- Conditions
- Dysmenorrhea Primary
- Being tested
- taVNS, SHAM stimulation
- Keywords
- Dysmenorrhea, transauricular vagal nerve stimulation, Pain
- Medical subject headings
- Dysmenorrhea, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNSDevice
Intervention Name: Transauricular Vagus Nerve Stimulation (taVNS)
Intervention Description:
Participants will receive transauricular vagus nerve stimulation on the tragus. Frequency: 2 sessions per day (one at 10 AM and one at 6 PM). Duration: Each session will last 15 minutes. Treatment Cycle: Stimulation will be applied for 5 days each month, starting 2 days before the expected beginning of the menstrual cycle, for a total of 2 months. The participants will adjust the level of maximum stimulation they considered painless.
SHAM stimulationDevice
Intervention Name: SHAM stimulation of the earlobe. Participants will receive SHAM stimulation on the earlobe, which does not stimulate the vagus nerve.
Frequency: 2 sessions per day (one at 10 AM and one at 6 PM). Duration: Each session will last 15 minutes. Treatment Cycle: Placebo stimulation will be applied for 5 days each month, starting 2 days before the expected beginning of the menstrual cycle, for a total of 2 months. The participants will adjust the level of maximum stimulation they considered painless.
| Study group | Role | What they receive |
|---|---|---|
| taVNS - transauricular vagal nerve stimulation | Experimental | Transauricular Vagus Nerve Stimulation (taVNS) will be applied in the tragus with the following parameters:
Pulse width: 500 microseconds; Frequency: 25 Hz; Stimulation cycle: 30 seconds on, 30 seconds off; Duration: 15 minutes per session; Current: Adjustable between 0 and 10 mA, with step increments of 0.1 mA. Receives: Device: taVNS |
| SHAM stimulation | Sham comparator | Stimulation of the earlobe will be applied with the following parameters:
Pulse width: 500 microseconds; Frequency: 25 Hz; Stimulation cycle: 30 seconds on, 30 seconds off; Duration: 15 minutes per session; Current: Adjustable between 0 and 10 mA, with step increments of 0.1 mA. Receives: Device: SHAM stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction the use of rescue medications
Significative reduction in the number of cases of rescue medication after the treatment employing the taVNS in respect to the sham condition.
Measured: During the first 3 days of menstrual
Secondary outcomes (4)
Reduction in acute and mean menstrual pain severity
Significative reduction in acute and mean (across the 3 days) menstrual pain severity assessed via Numeric Rating Scale (NRS) after the treatment employing the taVNS in respect to the sham condition.
Measured: During the first 3 days of menstrual
Reduction in menstrual pain severity at the Short form McGill Pain Questionnarie
Reduction in menstrual pain severity employing using the Short form McGill pain questionnaire during the experimental condition in comparison to the sham condition
Measured: During the first 3 days of menstrual
Changes in affective symptoms
Decrease of the score in at least one if the following scale: in Trait Anxiety Inventory (STAI), Beck's Depression Inventory II, Positive and Negative Affect Schedule (PANAS) and Pain Catastrophizing Scale (PCS).
Measured: First day of stimulation, last day of stimulation.
Changes in fMRI signal in the mesocorticolimbic system
Changes in fMRI signal in the areas of the mesocorticolimibic system during the execution of a reward fMRI task (Monetary incentive delay task, Kuntson et al., 2001).
Measured: After the first month application of the taVNS and of the SHAM stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 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, stefania, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912386
- Sponsor's protocol ID
- UESTC-neuSCAN-99
- Other IDs
- taVNS_DYSM_01
- Acronym
- taVNS-DYSM
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Primary and secondary outcomes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Two-Way Crossover Comparison Study of Pain Relief From Dysmenorrhea Employing taVNS and Sham Stimulation
- ClinicalTrials.gov ID
- NCT06912386
- Acronym / sponsor ID
- taVNS-DYSM / UESTC-neuSCAN-99
- Conditions
- Dysmenorrhea Primary
- Keywords
- Dysmenorrhea, transauricular vagal nerve stimulation, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 4 Apr 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.
The goal of this clinical trial is to determine if transauricular vagal nerve stimulation (taVNS) is effective in treating moderate dysmenorrhea. The main question it aims to answer is:
- Does taVNS reduce the number of times participants suffering from dysmenorrhea need to use rescue medication during menstruation? Researchers will compare taVNS stimulation with a sham stimulation (a look-alike procedure that does not stimulate the vagus nerve) to assess whether taVNS is effective in treating moderate dysmenorrhea.
Participants will:
- Undergo taVNS for 2 months and sham stimulation for another 2 months, each for 5 days per month, starting 2 days before the expected beginning of their menstrual cycle.
- Visit the clinic twice a month for checkups and tests.
- Keep a diary to record their pain levels and the number of times they use rescue medication.
- Undergo functional magnetic resonance imagine two times (one after the end of the first use of taVNS and another after the end of the first use of SHAM stimulation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS - transauricular vagal nerve stimulation | Experimental | Device: taVNSTransauricular Vagus Nerve Stimulation (taVNS) will be applied in the tragus with the following parameters: Pulse width: 500 microseconds; Frequency: 25 Hz; Stimulation cycle: 30 seconds on, 30 seconds off; Duration: 15 minutes per session; Current: Adjustable between 0 and 10 mA, with step increments of 0.1 mA. |
| SHAM stimulation | Sham comparator | Device: SHAM stimulationStimulation of the earlobe will be applied with the following parameters: Pulse width: 500 microseconds; Frequency: 25 Hz; Stimulation cycle: 30 seconds on, 30 seconds off; Duration: 15 minutes per session; Current: Adjustable between 0 and 10 mA, with step increments of 0.1 mA. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Regular menstrual cycle (28 days ± 7 days);
- Average moderate menstrual pain (with 4 - 7 NRS scores);
- History of over-the-counter (OTC) analgesic use for the treatment of menstrual pain (at least 1 IBUPROFEN for the first two days);
- 4 consecutive monthly menstrual cycles;
- Non-pregnant status;
Key exclusion criteria (16 listed)
- Currently under medications (except for analgesic medication for menstrual cycle);
- Use of oral contraceptive;
- Secondary cause for dysmenorrhea (i.e., endometriosis, adenomyosis, uterine fibroids, or infection);
- Unstable or serious illness (e.g., kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, lung conditions, chronic asthma, diagnosed psychological or mood disorder, hypertension, any bleeding disorders, recent surgery, or concurrent blood thinning treatment);
- Current malignancy or treatment for malignancy within the previous 2 years;
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 |
|---|---|---|
| taVNSIntervention Name: Transauricular Vagus Nerve Stimulation (taVNS) Intervention Description: Participants will receive transauricular vagus nerve stimulation on the tragus. Frequency: 2 sessions per day (one at 10 AM and one at 6 PM). Duration: Each session will last 15 minutes. Treatment Cycle: Stimulation will be applied for 5 days each month, starting 2 days before the expected beginning of the menstrual cycle, for a total of 2 months. The participants will adjust the level of maximum stimulation they considered painless. | Device | taVNS - transauricular vagal nerve stimulation |
| SHAM stimulationIntervention Name: SHAM stimulation of the earlobe. Participants will receive SHAM stimulation on the earlobe, which does not stimulate the vagus nerve. Frequency: 2 sessions per day (one at 10 AM and one at 6 PM). Duration: Each session will last 15 minutes. Treatment Cycle: Placebo stimulation will be applied for 5 days each month, starting 2 days before the expected beginning of the menstrual cycle, for a total of 2 months. The participants will adjust the level of maximum stimulation they considered painless. | Device | SHAM stimulation |
Primary outcome
Reduction the use of rescue medications
Time frame: During the first 3 days of menstrual
Significative reduction in the number of cases of rescue medication after the treatment employing the taVNS in respect to the sham condition.
4 secondary outcomes
Reduction in acute and mean menstrual pain severity
Time frame: During the first 3 days of menstrual
Reduction in menstrual pain severity at the Short form McGill Pain Questionnarie
Time frame: During the first 3 days of menstrual
Changes in affective symptoms
Time frame: First day of stimulation, last day of stimulation.
Changes in fMRI signal in the mesocorticolimbic system
Time frame: After the first month application of the taVNS and of the SHAM stimulation
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 4 Apr 2025.
- Individual participant dataSharing planned: Yes. Primary and secondary outcomes
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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 study testing taVNS in people with Dysmenorrhea Primary, 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 10 inclusion and 16 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 4 Apr 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.
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 Stefania Ferraro, PhD (+86 18684009672, stefania@uestc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction the use of rescue medications (time frame: During the first 3 days of menstrual). 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 4 Apr 2025.