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

NCT07688720 | Recruiting FDA Device

• 1 other identifier: IRB#2025-397
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Perimenopause; PMDD

Keywords

Premenstrual Symptoms; Menopause; Women's health; Perimenopause; Premenstrual Dysphoric Disorder

Outcome Measures

Primary Outcomes (2)

• Daily Record of Severity of Problems (DRSP)

  The DRSP assesses psychological and physical premenstrual symptoms. This is the primary outcome in the PMS/PMDD study.

  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

  The Green Climacteric Scale assesses the degree to which respondents are bothered by a range of different menopausal symptoms. This is the primary outcome in the Perimenopause Study.

  Participants will complete this measure monthly from study initiation until the end of the study, about three months.

Secondary Outcomes (11)

• Daily Mood

  Participants will fill this out daily from study initiation until the end of the study, about 3 months in the perimenopause study and 4 months in the PMS/PMDD study (4 cycles). Menstrual cycle length varies but is generally 21-35 days.

• Daily Hot Flash Frequency

  Participants will respond to questions about hot flash frequency daily from study initiation until the end of the study, about three months.

• Daily Hot Flash Severity

  Participants will respond to questions about hot flash severity daily from study initiation until the end of the study, about three months.

• Daily Sleep Quality

  Participants will respond to this question daily from study initiation until the end of the study, about three months.

• Premenstrual Symptoms Screening Tool (PSST)

  Participants will complete this measure each cycle from study initiation until the end of the study, about four months (4 cycles). Menstrual cycle length varies but is generally 21-35 days.

Study Arms (1)

tAN treatment

EXPERIMENTAL

For perimenopausal women: tAN administration 2 hours daily. For PMS/PMDD women: tAN administration 2 hours daily during the luteal phase.

Device: transcutaneous auricular neurostimulation (tAN)

Interventions

transcutaneous auricular neurostimulation (tAN) DEVICE

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)

Also known as: Sparrow Link

tAN treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify 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
• 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

Sponsors & Collaborators

• Texas Christian University: lead
• Spark Biomedical, Inc.: collaborator

Study Sites (1)

Texas Christian University

Fort Worth, Texas, 76109, United States

RECRUITING

MeSH Terms

Conditions

Premenstrual Dysphoric Disorder

Condition Hierarchy (Ancestors)

Premenstrual Syndrome; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Sarah E Hill, PhD

  Texas Christian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah E Hill, PhD

CONTACT

817-257-6424; s.e.hill@tcu.edu

Savannah A Hastings, M.S.

CONTACT

817-257-4989; s.a.hastings@tcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: July 7, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The investigators will share data at the time of publication. There will be no end date, data will be made available indefinitely.
• Access Criteria: The investigators will post the deidentified data on open science framework, meaning that it will be publicly available for any researchers who wish to download it.

Locations

US (1)