Recruiting

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

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.

ClinicalTrials.gov IDNCT07688720

PhaseNA

Enrollment20

SponsorTexas Christian University

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Perimenopause, PMDD

About this study

Interventions

Device: transcutaneous auricular neurostimulation (tAN) — Device: Sparrow Link. The Sparrow Link will be using the components of the Sparrow Ascent device: (FDA-cleared K230796) a wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and/or around the auricle. This device will stimulate the auriculotemporal nerve (ATN) and the auricular branch of the vagus nerve (ABVN)

Primary outcomes

Daily Record of Severity of Problems (DRSP) (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.)
Green Climacteric Scale (Participants will complete this measure monthly from study initiation until the end of the study, about three months.)

Eligibility information

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 locations

Texas Christian University, Fort Worth, Texas 76109 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.