Pain Relief From Dysmenorrhea Employing taVNS

NCT ID: NCT06912386

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-06-30

Brief 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? 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).

Conditions

Dysmenorrhea Primary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

taVNS - transauricular vagal nerve stimulation

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.

Group Type: EXPERIMENTAL

taVNS

Intervention Type: DEVICE

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 stimulation

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.

Group Type: SHAM_COMPARATOR

SHAM stimulation

Intervention Type: DEVICE

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.

Interventions

taVNS

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.

Intervention Type: DEVICE

SHAM stimulation

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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;
• 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);

Exclusion Criteria

• 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;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Electronic Science and Technology of China

OTHER

Sponsor Role: lead

Responsible Party

stefania

Prof. Stefania Ferraro

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UESTC

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Stefania Ferraro, PhD

Role: CONTACT

stefania@uestc.edu.cn

+86 18684009672

Jaili He

Role: CONTACT

jiali@uestc.edu.cn

+8615828121558

Facility Contacts

stefania Ferraro, PhD

Role: primary

stefania@uestc.edu.cn

Other Identifiers

taVNS_DYSM_01

Identifier Type: OTHER

Identifier Source: secondary_id

UESTC-neuSCAN-99

Identifier Type: -

Identifier Source: org_study_id