Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Patients With and Without Von Willebrand Disease (VWD/HMB)

Five Liters, Inc.

Status: Completed

Conditions: Von Willebrand Disease, Type 1; Heavy Menstrual Bleeding

Treatments: Device: Volta System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06064851

5L-BLD-05

Details and patient eligibility

About

The objectives of this study are to determine if transcutaneous auricular neurostimulation (tAN) can modulate hemostasis, improve perceived quality of life, and improve pain during the menstrual cycle of von Willebrand Disease (VWD) patients.

Full description

This study is designed as an open label, two-arm, decentralized clinical study in which patients with heavy menstrual bleeding (HMB) will receive tAN, which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN). Participants will be enrolled into one of two cohorts of the study over the course of two consecutive menstrual cycles.

1. Patients with VWD Type 1 who are on hormone therapy (n=15)
2. Patients with no known cause of HMB who are not currently on hormone therapy (n=15)

During the First Menstruation (baseline), no tAN treatment will be delivered. Participants will estimate blood loss daily throughout the duration of the menstruation phase of their first menstrual cycle. Dysmenorrhea, a general quality of life assessment, and total duration of menstruation will be collected on the final day of first menstruation.

During the Second Menstruation, participants will self-administer 2, 1-hour sessions (daily total of 2 hours) of active tAN daily beginning Day 1 of menstruation through the final day of second menstruation. Participants will estimate blood loss daily throughout the duration of the menstruation phase of their second menstruation. Dysmenorrhea, a general quality of life assessment, and total duration of menstruation will be collected on the final day of second menstruation.

Enrollment: 29 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Regularly menstruating female participants between 18-45 years of age
2. Typical length of menstruation ranging from 7 to 14 days
3. History of menorrhagia as assessed by the Menstrual Bleeding Questionnaire
4. For patients who have been diagnoses with von Willebrand Disease Type 1: On hormone therapy (with the exception of Nexplanon- at least three months) and willing to continue use for the duration of the study
5. For participants with idiopathic heavy menstrual bleeding: No use of hormon therapy for at least the past three months
6. No changes to all current medications and supplements in the past three months, willingness to continue use for duration of study, and not start any new medications or homeopathic remedies
7. Reliable access to an Internet-enabled device to complete required questionnaires
8. 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. Antifibrinolytic use within 30 days of enrollment
4. Acquired bleeding disorder
5. Use of anticoagulants (i.e., Aspirin, Warfarin, Coumadin, etc.) including platelet inhibitors for 30 days prior to enrollment
6. Use of the Copper intrauterine device within the past 3 months
7. Known structural cause of heavy menstrual bleeding
8. Use of menstrual cups as a method of menstrual blood collection
9. 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
10. Participant has received a blood transfusion within 30 days prior to study
11. Participant has a history of epileptic seizures
12. Participant has a history of neurologic diseases or traumatic brain injury
13. Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators)
14. Participant has abnormal ear anatomy or ear infection present
15. 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Von Willebrand Disease (VWD) Patients

Experimental group

Description:

Participants with VWD Type 1 who are on hormone therapy. First Menstruation (baseline/no active tAN) followed by Second Menstruation (active tAN)

Treatment:

Device: Volta System

Heavy Menstrual Bleeding (HMB) Patients

Experimental group

Description:

Participants with no known cause of HMB who are not on hormonal therapy. First Menstruation (baseline/no active tAN) followed by Second Menstruation (active tAN)

Treatment:

Device: Volta System