Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial

NCT06814028 | Completed FDA Device

• 1 other identifier: 5L-BLD-07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as an open label, single-arm, decentralized research study in which patients with idiopathic heavy menstrual bleeding will receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN). Participants will be enrolled over the course of three menstruations: one baseline menstruation and two menstruations with added daily neurostimulation.

Conditions

Heavy Menstrual Bleeding

Keywords

Neurostimulation; Hemostasis; Menstrual cycle; Menstruation; Blood loss; PBAC; Menorrhagia; CMSS; Transcutaneous Auricular Neurostimulation; tAN; Heavy menstrual bleeding

Outcome Measures

Primary Outcomes (3)

• Blood loss

  Comparison of mean Pictorial Bleeding Assessment Chart (PBAC) scores during first menstruation (no stimulation) versus second and third menstruations (active stimulation). The PBAC is a widely accepted tool for patients with HMB to account for menstrual blood loss. Menstrual blood loss is estimated through a selection of images of tampons, pads, clots, and flooding events. Patients mark a tally next to the images that best match each of the menstruation products they used that day.

  Daily throughout all three menstruations (up to 3 complete menstrual cycles - estimated 90 days)

• Quality of life

  Comparison of mean quality of life score measured by the Short Form 36 (SF-36) during first menstruation (no stimulation) versus second and third menstruations (active stimulation). The SF-36 is a 36-item patient-reported questionnaire that assesses general quality of life. This questionnaire includes eight variables: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy and vitality, pain, and general perception of health. The SF-36 is scored using a standardized scoring algorithm or by the SF-36 scoring software. The SF-36 scores range from 0 to 100, with higher scores representing better health status.

  Final day of each menstruation (up to 3 complete menstrual cycles - estimated 90 days)

• Duration and severity of dysmenorrhea

  Comparison of mean Cox Menstrual Symptom Scale (CMSS) scores during first menstruation (no stimulation) versus second and third menstruations (active stimulation). The CMSS measures menstrual distress and dysmenorrhea. The CMSS Severity subscale is an 18-item self-reported scale that measures severity of menstrual symptoms, including pain, nausea, emotions, etc. during menstruation. The CMSS will be used in this trial to measure a participant's dysmenorrhea every day of each menstruation. Each CMSS item is scored from 0-4, with a higher score indicating higher dysmenorrhea severity.

  Final day of each menstruation (up to 3 complete menstrual cycles - estimated 90 days)

Study Arms (1)

Heavy Menstrual Bleeding Patients

EXPERIMENTAL

Participants with no known cause of HMB who are not on hormonal therapy. First Menstruation (baseline/no active tAN) followed by Second Menstruation (2 one-hour active tAN sessions daily) followed by Third Menstruation (1 two-hour active tAN session daily).

Device: Volta System

Interventions

Volta System DEVICE

The Volta System 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. During the Second and Third Menstruations, participants will self-administer daily active tAN sessions Volta System Device beginning Day 1 of menstruation through the final day of menstruation.

Heavy Menstrual Bleeding Patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Regularly menstruating females.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Regularly menstruating female participants between 18-45 years of age
• History of menorrhagia as assessed by the Menorrhagia Screening Tool
• Stable/consistent use of current medications and supplements for the past three months, willingness to continue use for duration of study, and not start any new medications or homeopathic remedies
• Reliable access to an internet-enabled device to complete required questionnaires
• Willingness to consistently use the same brand of tampons and/or pads throughout duration of the study

You may not qualify if:

• Pregnancy within three months of enrollment
• Lactating at the time of enrollment
• Typical length of menstruation greater than 14 days
• Use of hormone therapy in the past three months
• Antifibrinolytic use within 30 days of enrollment
• Known inherited or acquired bleeding disorder
• Use of anticoagulants (i.e., Aspirin, Warfarin, Coumadin, etc.) including platelet inhibitors for 30 days prior to enrollment
• Use of the Copper intrauterine device within the past 3 months
• Known structural cause of heavy menstrual bleeding
• Use of menstrual cups or menstrual underwear as a method of menstrual blood collection
• Participant has a history of chronic tobacco use or has ingested nicotine via smoking, vaping, smokeless tobacco, or nicotine patches in the past three months
• Participant has received a blood transfusion within 30 days prior to study
• Participant has a history of epileptic seizures
• Participant has a history of neurologic diseases or traumatic brain injury
• Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators)

Sponsors & Collaborators

• Spark Biomedical, Inc.: lead
• Five Liters, Inc.: collaborator

Study Sites (1)

Five Liters - DECENTRALIZED STUDY

Dallas, Texas, 75252, United States

Location

MeSH Terms

Conditions

Menorrhagia; Hemorrhage

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants with idiopathic HMB will be enrolled in the study over the course of three consecutive menstrual cycles. First Menstruation will be baseline. The Second Menstruation participants will self-administer 2, 1-hour sessions of active tAN daily beginning Day 1 of menstruation through the final day of menstruation. The Third Menstruation participants will self-administer 1, 2-hour session of active tAN daily beginning Day 1 of menstruation through the final day of menstruation.

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: February 14, 2025
• Primary Completion: September 24, 2025
• Study Completion: September 24, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

US (1)