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

Part of paid clinical trials in Fort Worth, Texas.

Sponsor
Texas Christian University
Study ID
NCT07688720
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

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)

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Daily Record of Severity of Problems (DRSP) [ Time Frame: 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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Christian UniversityFort WorthTexas76109
Sarah E Hill, PhD
[email protected]
817-257-6424
Savannah A Hastings, M.S.
[email protected]
8172574989
Sarah E Hill, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fort Worth, TX

By condition
Menopause
By specialty
Women's healthFertility
By research site
Texas Christian University· Fort Worth, TX

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