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

NCT06064851 | Completed FDA Device

• 1 other identifier: 5L-BLD-05
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Von Willebrand Disease, Type 1; Heavy Menstrual Bleeding

Keywords

Transcutaneous auricular vagus nerve stimulation; Neurostimulation; Hemostasis; Menstrual cycle; Menstruation; Blood loss; Hormone therapy; PBAC; Menorrhagia; CMSS

Outcome Measures

Primary Outcomes (4)

• Blood loss during menses in both groups

  Comparison of mean Pictorial Bleeding Assessment Chart (PBAC) scores during first menstruation (no stimulation) versus second menstruation (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. This trial will utilize a modified version of the Wyatt et al. 2001 PBAC, where a tally system will be added to each of the images.

  Daily throughout both menstruations (up to 2 complete menstrual cycles- estimated 60 days)

• Quality of Life in both groups

  Comparison of mean quality of life score measured by the Short Form 36 (SF-36) during first menstruation (no stimulation) versus second menstruation (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 2 complete menstrual cycles- estimated 60 days)

• Duration and severity of dysmenorrhea in both groups

  Comparison of mean Cox Menstrual Symptom Scale (CMSS) scores during first menstruation (no stimulation) versus second menstruation (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 2 complete menstrual cycles- estimated 60 days)

• Duration of menstruation in both groups

  Compare duration of menstruation between first menstruation (no stimulation) versus second menstruation (active stimulation).

  Final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)

Study Arms (2)

Von Willebrand Disease (VWD) Patients

EXPERIMENTAL

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

Device: Volta System

Heavy Menstrual Bleeding (HMB) 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 (active tAN)

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 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; Von Willebrand Disease (VWD) Patients

Eligibility Criteria

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

You may qualify if:

• Regularly menstruating female participants between 18-45 years of age
• Typical length of menstruation ranging from 7 to 14 days
• History of menorrhagia as assessed by the Menstrual Bleeding Questionnaire
• 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
• For participants with idiopathic heavy menstrual bleeding: No use of hormon therapy for at least the past three months
• 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
• 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
• Antifibrinolytic use within 30 days of enrollment
• 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 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)
• Participant has abnormal ear anatomy or ear infection present
• 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

Sponsors & Collaborators

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

Study Sites (1)

Five Liters

Dallas, Texas, 75252, United States

Location

MeSH Terms

Conditions

von Willebrand Disease, Type 1; Menorrhagia; Hemorrhage

Condition Hierarchy (Ancestors)

von Willebrand Diseases; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; 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 Officials

• Navid Khodaparast, PhD

  Chief Science Officer

  PRINCIPAL INVESTIGATOR

• Melanie McWade, PhD

  Senior Director of Clinical Operations

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking; open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: October 3, 2023
• Study Start: October 27, 2023
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (1)