An interventional study of taVNS and SHAM stimulation in Dysmenorrhea Primary, sponsored by University of Electronic Science and Technology of China. Recruiting at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by University of Electronic Science and Technology of China · Not applicable, Interventional, and Treatment
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:
Participants will:
398 studies on the registry are indexed under Dysmenorrhea; 96 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 333 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →University of Electronic Science and Technology of China is the lead sponsor of 109 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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 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.
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.
Time frame: During the first 3 days of menstrual
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.
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: After the first month application of the taVNS and of the SHAM stimulation
Plan to share: Yes — Primary and secondary outcomes
Supporting information: Study protocol
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University of Electronic Science and Technology of China