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Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether nerve stimulation through the skin of the ear (tAN) helps symptoms of PMS, PMDD, or perimenopause. PMS and PMDD cause symptoms before a period; perimenopause is the time leading up to menopause. Participants will complete surveys before, during, and after treatment.

Transcutaneous Auricular Neurostimulation (tAN) will be administered to women with premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), and perimenopause. The investigators will examine whether tAN improves symptomology by collecting self-report data before the intervention, during the intervention, and following the intervention.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both groups: Assigned female at birth.
  • Both groups: Able to reliably complete online surveys.
  • Both groups: Study staff will confirm symptoms soon after enrollment.
  • PMS/PMDD group: Age 18 to 45.
  • PMS/PMDD group: Have natural, regular periods and identify as having PMS or PMDD.
  • Perimenopause group: Age 40 to 55.
  • Perimenopause group: Have periods that have recently become less regular, or identify as being in perimenopause.

Who can't join

  • Both groups: Using hormonal birth control, pregnant, or breastfeeding.
  • Both groups: History of seizures, any implanted device, or any current or past heart condition.
  • Both groups: Unusual ear shape, ear piercings that cannot be removed, or a recent ear infection.
  • Both groups: Taking SSRIs (a type of antidepressant), steroids, or hormone therapy.
  • Both groups: Expect to start or stop prescription medicines during the study.
  • Both groups: History of a brain or nervous system disease, such as stroke or brain tumor, or a brain injury from trauma in the past 12 months.
  • PMS/PMDD group only: Any other mental illness or mood disorder.
  • Perimenopause group only: Have had a hysterectomy (surgery to remove the uterus).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

PMS/PMDD Study: Inclusion Criteria: * Assigned female at birth * Age 18 to 45 * Naturally cycling * Regularly occurring menstrual cycle * Must identify as having PMS or PMDD * Reliable ability to complete online study surveys Exclusion Criteria: * Using hormonal birth control * Pregnant or lactating/breastfeeding * History of seizures * Implanted devices * Current or previous diagnosis of any heart conditions * Abnormal ear anatomy * Non-removable piercings on the ear * Recent ear infection * Taking SSRIs * Taking steroids * Taking hormone therapy * If the participant anticipates starting or stopping prescription medications during the study period * Participant has a history of neurologic diseases (i.e. stroke, brain tumor, cerebrovascular, etc.) * Participant has a history traumatic brain injury within the past 12 months * Must not have any other mental illness or mood disorder Perimenopause Study: Inclusion Criteria: * Assigned female at birth. * Age 40 to 55 * Must have newly variable menstrual cycles or report identifying as perimenopausal * Reliable ability to complete online study surveys Exclusion Criteria: * Using hormonal birth control * Pregnant or lactating/breastfeeding * History of seizures * Implanted devices * Current or previous diagnosis of any heart conditions * Abnormal ear anatomy * Non-removable piercings on the ear * Recent ear infection * Taking SSRIs * Taking steroids * Taking hormone therapy * If the participant anticipates starting or stopping prescription medications during the study period. * Participant has a history of neurologic diseases (i.e. stroke, brain tumor, cerebrovascular, etc.) * Participant has a history traumatic brain injury within the past 12 months * have a hysterectomy In both studies we will confirm that participants are symptomatic shortly following enrollment.

Study sites (1)

TX