Clinical trial NCT06814028: Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial
Official title: Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heavy Menstrual Bleeding
Keywords: Neurostimulation
Hemostasis
Menstrual cycle
Menstruation
Blood loss
PBAC
Menorrhagia
CMSS
Lead sponsor: Spark Biomedical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Five Liters, Inc.
First posted: 2025-02-07
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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 three months, willingness to continue use for duration of study, and not start any new medications 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 throughout duration of the study

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 platelet inhibitors 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 blood collection
11. 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
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 of the Investigator, may either put the participants are risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Primary outcomes:
measure: Blood loss
timeFrame: Daily throughout all three menstruations (up to 3 complete menstrual cycles - estimated 90 days)
measure: Quality of life
timeFrame: Final day of each menstruation (up to 3 complete menstrual cycles - estimated 90 days)
measure: Duration and severity of dysmenorrhea
timeFrame: Final day of each menstruation (up to 3 complete menstrual cycles - estimated 90 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Five Liters - DECENTRALIZED STUDY
state: Texas
Study officials:
References: