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.

Study Overview

• Status: Recruiting
• Conditions: Perimenopause; PMDD
• Intervention / Treatment: Device: transcutaneous auricular neurostimulation (tAN)

Detailed Description

The PMS/PMDD study will last four menstrual cycles, for an average of four months in length. The first cycle will be baseline (pre-treatment), the next two cycles will be intervention (treatment), and one final cycle will be follow-up (post-treatment).

The perimenopause study will last three months. The first month will be baseline (pre-treatment), the next month will be intervention (treatment), and the final month will be follow-up (post-treatment).

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah E Hill, PhD; Phone Number: 817-257-6424; Email: s.e.hill@tcu.edu
• Study Contact Backup: Name: Savannah A Hastings, M.S.; Phone Number: 817-257-4989; Email: s.a.hastings@tcu.edu

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76109
      • Recruiting
      • Texas Christian University
      • Contact: Sarah E Hill, PhD; Phone Number: 817-257-6424; Email: s.e.hill@tcu.edu
      • Contact: Savannah A Hastings, M.S.; Phone Number: 8172574989; Email: s.a.hastings@tcu.edu
      • Principal Investigator: Sarah E Hill, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: tAN treatment; 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); 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); Other Names: Sparrow Link

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Mood	Each day, participants will be asked to respond to the question "How is your mood today?". Response options range from 1 = extremely bad/negative to 7 = extremely good/positive. This is a secondary outcome in both studies.	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	Hot flash frequency will be assessed. This is a secondary outcome in the Perimenopause Study.	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	Hot flash severity will be assessed. This is a secondary outcome in the Perimenopause Study.	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	Each day, participants will be asked to respond to the question, "How well did you sleep last night?". Response options range from 1 = Very poor to 5 = Excellent. This is a secondary outcome in the Perimenopause study.	Participants will respond to this question daily from study initiation until the end of the study, about three months.
Premenstrual Symptoms Screening Tool (PSST)	The PSST evaluates severity of premenstrual symptoms. This is a secondary outcome in the PMS/PMDD study.	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.
Depression (PHQ-8)	Each cycle participants will complete the Patient Health Questionnaire-8 (PHQ-8) that assesses depression. In both studies this is a secondary outcome.	Participants will complete this measure each month/cycle 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.
Anxiety (GAD-7)	Each cycle/month participants will complete the Generalized Anxiety Disorder-7 (GAD-7) scale that assesses anxiety symptoms. This is a secondary outcome in both studies.	Participants will complete this measure each cycle/month 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.
Insomnia Severity Index (ISI)	Assesses sleep quality and sleep issues. This is a secondary outcome in both studies.	Participants will complete the ISI each cycle or monthly 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.
Positive and Negative Affect Schedule (PANAS)	The PANAS is a self-report measure of a range of positive and negative emotions participants may be experiencing. This is a secondary outcome in both studies.	Participants will complete the PANAS each month/cycle 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.
Menopause Quality of Life Questionnaire	The Menopause Quality of Life Questionnaire measures how frequently participants have been bothered by a range of different menopausal symptoms. This is a secondary outcome in the Perimenopause Study.	Participants will respond to this questionnaire monthly from study initiation until the end of the study, about three months.
Device Usability Questionnaire	Questionnaire designed to assess participants' overall satisfaction with the device and to evaluate how easily they were able to operate it using the provided instructions and support materials. This is a secondary outcome in both studies.	This will be administered at the end of the treatment period. Perimenopause study: this will be administered after month 2 (out of 3). PMS/PMDD study: this will be administered after cycle 3 (out of 4). Cycle length varies but is generally 21-35 days.

Collaborators and Investigators

• Sponsor: Texas Christian University
• Collaborators: Spark Biomedical, Inc.
• Investigators: Principal Investigator: Sarah E Hill, PhD, Texas Christian University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Menopause; Perimenopause; Women's health; Premenstrual Dysphoric Disorder; Premenstrual Symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Depressive Disorder; Menstruation Disturbances; Premenstrual Syndrome; Pathological Conditions, Signs and Symptoms; Premenstrual Dysphoric Disorder
• Other Study ID Numbers: IRB#2025-397

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Primary and secondary outcomes will be shared.
• IPD Sharing Time Frame: The investigators will share data at the time of publication. There will be no end date, data will be made available indefinitely.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No