Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Patients With and Without Von Willebrand Disease

NCT ID: NCT06064851

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-27
• Study Completion Date: 2025-04-18

Brief Summary

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.

Detailed 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.

Conditions

Von Willebrand Disease, Type 1; Heavy Menstrual Bleeding

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Von Willebrand Disease (VWD) Patients

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

Group Type: EXPERIMENTAL

Volta System

Intervention Type: 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 Second Menstruation, participants will self-administer 2, 1-hour sessions of active tAN daily with the Volta System Device beginning Day 1 of second menstruation through the final day of second menstruation.

Heavy Menstrual Bleeding (HMB) Patients

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)

Group Type: EXPERIMENTAL

Volta System

Intervention Type: 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 Second Menstruation, participants will self-administer 2, 1-hour sessions of active tAN daily with the Volta System Device beginning Day 1 of second menstruation through the final day of second menstruation.

Interventions

Volta System

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 Second Menstruation, participants will self-administer 2, 1-hour sessions of active tAN daily with the Volta System Device beginning Day 1 of second menstruation through the final day of second menstruation.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Spark Biomedical, Inc.

INDUSTRY

Sponsor Role: collaborator

Five Liters, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Navid Khodaparast, PhD

Role: PRINCIPAL_INVESTIGATOR

Chief Science Officer

Melanie McWade, PhD

Role: STUDY_DIRECTOR

Senior Director of Clinical Operations

Locations

Five Liters

Dallas, Texas, United States

Countries

United States

Other Identifiers

5L-BLD-05

Identifier Type: -

Identifier Source: org_study_id