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

Last updated: April 8, 2025
Sponsor: Spark Biomedical, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Dysfunctional Uterine Bleeding

Hemorrhage

Female Hormonal Deficiencies/abnormalities

Treatment

Volta System

Clinical Study ID

NCT06814028
5L-BLD-07
  • Ages 18-45
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Regularly menstruating female participants between 18-45 years of age

  2. History of menorrhagia as assessed by the Menorrhagia Screening Tool

  3. Stable/consistent use of current medications and supplements for the past threemonths, willingness to continue use for duration of study, and not start any newmedications or homeopathic remedies

  4. Reliable access to an internet-enabled device to complete required questionnaires

  5. Willingness to consistently use the same brand of tampons and/or pads throughoutduration of the study

Exclusion

Exclusion Criteria:

  1. Pregnancy within three months of enrollment

  2. Lactating at the time of enrollment

  3. Typical length of menstruation greater than 14 days

  4. Use of hormone therapy in the past three months

  5. Antifibrinolytic use within 30 days of enrollment

  6. Known inherited or acquired bleeding disorder

  7. Use of anticoagulants (i.e., Aspirin, Warfarin, Coumadin, etc.) including plateletinhibitors for 30 days prior to enrollment

  8. Use of the Copper intrauterine device within the past 3 months

  9. Known structural cause of heavy menstrual bleeding

  10. Use of menstrual cups or menstrual underwear as a method of menstrual bloodcollection

  11. Participant has a history of chronic tobacco use or has ingested nicotine viasmoking, vaping, smokeless tobacco, or nicotine patches in the past three months

  12. Participant has received a blood transfusion within 30 days prior to study

  13. Participant has a history of epileptic seizures

  14. Participant has a history of neurologic diseases or traumatic brain injury

  15. Participant has presence of devices (e.g., pacemakers, cochlear prostheses,neurostimulators)

  16. Participant has abnormal ear anatomy or ear infection present

  17. Participant has any other significant disease or disorder which, in the opinion ofthe Investigator, may either put the participants are risk because of participationin the trial, or may influence the result of the trial, or the participant's abilityto participate in the trial

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Volta System
Phase:
Study Start date:
February 14, 2025
Estimated Completion Date:
June 30, 2025

Study Description

This study is designed as an open label, single arm, cross-over decentralized clinical 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) via the mastoid and the auriculotemporal nerve (ATN) anterior to the tragus. Participants will be enrolled into the study over the course of three consecutive menstrual cycles.

During the First Menstruation (baseline), no tAN treatment will be delivered. Participants will estimate blood loss using the Pictorial Bleeding Assessment Chart (PBAC) daily throughout the duration of the menstruation phase of their menstrual cycle. Menstrual symptoms will be assessed using the Cox Menstrual Symptom Scale (CMSS) and a general quality of life assessment will be conducted on the final day of menstruation using the Short-Form 36 (SF-36).

During the Second Menstruation, participants will self-administer two 1-hour active tAN sessions daily (once in the AM, once in the PM), beginning Day 1 of menstruation through the final day of menstruation. Blood loss will be assessed daily using the PBAC throughout the duration of menstruation. Quality of life will be assessed with the CMSS and SF-36 on the final day of menstruation.

During the Third Menstruation, participants will self-administer a single 2-hour active tAN session each day, beginning Day 1 of menstruation through the final day of menstruation. Blood loss will be assessed daily using the PBAC throughout the duration of menstruation. Quality of life will be assessed with the CMSS and SF-36 on the final day of menstruation.

In addition, a device satisfaction survey will be completed at the end of the study. Participants will exit the study after the final day of their third menstruation.

Connect with a study center

  • Five Liters - DECENTRALIZED STUDY

    Dallas, Texas 75252
    United States

    Site Not Available

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