Pain Relief From Dysmenorrhea Employing taVNS

NCT06912386 | Recruiting DMC

• 2 other identifiers: UESTC-neuSCAN-99taVNS_DYSM_01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Dysmenorrhea; transauricular vagal nerve stimulation; Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  During the first 3 days of menstrual

Secondary Outcomes (4)

• Reduction in acute and mean menstrual pain severity

  During the first 3 days of menstrual

• Reduction in menstrual pain severity at the Short form McGill Pain Questionnarie

  During the first 3 days of menstrual

• Changes in affective symptoms

  First day of stimulation, last day of stimulation.

• Changes in fMRI signal in the mesocorticolimbic system

  After the first month application of the taVNS and of the SHAM stimulation

Study Arms (2)

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.

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.

Device: SHAM stimulation

Interventions

taVNS 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.

taVNS - transauricular vagal nerve stimulation

SHAM stimulation 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.

SHAM stimulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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);
• 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);

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• University of Electronic Science and Technology of China: lead

Study Sites (1)

UESTC

Chengdu, Sichuan, 611731, China

RECRUITING

MeSH Terms

Conditions

Dysmenorrhea; Pain

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Stefania Ferraro, PhD

CONTACT

+86 18684009672; stefania@uestc.edu.cn

Jaili He

CONTACT

+8615828121558; jiali@uestc.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Stefania Ferraro

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 4, 2025
• Study Start: April 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be available at the end of the relevant analyses with not limit of time.
• Access Criteria: IPD will be available on the platform OSF

Locations

CN (1)