Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Pe… (NCT07688720) | Clinical Trial Compass
RecruitingNot Applicable
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
United States20 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range
18 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 stopp…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Daily Record of Severity of Problems (DRSP)
Timeframe: Assessed daily from study initiation until the end of the study, an average of four months (4 cycles). Menstrual cycle length varies but is generally 21-35 days.
2
Green Climacteric Scale
Timeframe: Participants will complete this measure monthly from study initiation until the end of the study, about three months.