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New treatment option for Perimenopause
Official title Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
ClinicalTrials.gov ID: NCT07688720
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55, women only
You may be able to join if
- PMS/PMDD Study:
- Assigned female at birth
- Age 18 to 45
- Naturally cycling
- Regularly occurring menstrual cycle
You likely can't join if
- Using hormonal birth control
- Pregnant or lactating/breastfeeding
- History of seizures
- Implanted devices
- Current or previous diagnosis of any heart conditions
- Abnormal ear anatomy
See the full eligibility criteria
- PMS/PMDD Study:
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fort Worth, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort Worth, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.