Transcutaneous Auricular Neurostimulation for Premenstrual Dysphoric Disorder and Perimenopause

This trial tests a new method called transcutaneous auricular neurostimulation (tAN) to determine its effectiveness in alleviating symptoms of premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), and perimenopause. The researchers aim to gather feedback from participants to assess symptom improvement after using tAN. Women with PMS or PMDD who have regular menstrual cycles, or those experiencing new changes in their cycles and identify as perimenopausal, might be suitable candidates. Participants should not use hormonal birth control or have certain medical conditions, such as heart issues or recent ear infections. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options.

Yes, you will need to stop taking certain medications like SSRIs, steroids, and hormone therapy to participate in this trial. Also, you should not start or stop any prescription medications during the study period.

Research has shown that transcutaneous auricular neurostimulation (tAN) is generally well-tolerated. Although few studies focus specifically on tAN for premenstrual dysphoric disorder or perimenopause, similar methods like auricular acupressure have been found to reduce symptoms such as anxiety in perimenopausal women. This suggests that tAN might be safe and could help with these symptoms.

The phase of the clinical trial is also important. Since this trial is not in its early stages, tAN has already undergone initial safety checks. Serious side effects are unlikely, but participants should still report any problems to the study staff.

Transcutaneous auricular neurostimulation (tAN) is unique because it approaches the treatment of premenstrual dysphoric disorder (PMDD) and perimenopause symptoms through a non-invasive nerve stimulation technique. Unlike standard treatments like hormonal therapy or antidepressants, which can take time to adjust and often come with side effects, tAN directly targets the nervous system by stimulating specific nerves through the skin of the ear. Researchers are excited about this method because it offers a drug-free alternative that can be used daily, potentially providing faster relief with fewer side effects. This innovative approach could open up new avenues for managing symptoms in a way that fits seamlessly into daily life.

Research has shown that transcutaneous auricular neurostimulation (tAN) may help with premenstrual dysphoric disorder (PMDD). One study found that half of the women who received a similar treatment experienced complete relief from their symptoms, unlike those who received a placebo. This finding suggests that tAN could help reduce mood swings and irritability associated with PMDD. Although limited data exists on its effects on perimenopause and PMS, tAN might help balance brain activity, potentially easing symptoms. Early results indicate it is worth exploring for those dealing with these conditions. Participants in this trial will receive tAN treatment, administered for 2 hours daily, tailored to either perimenopausal women or those with PMS/PMDD.³⁶⁷⁸⁹