Clinical trial NCT06064851: Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Patients With and Without Von Willebrand Disease
Official title: Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Patients With and Without Von Willebrand Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Spark Biomedical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Spark Biomedical, Inc.
First posted: 2023-10-03
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Blood loss during menses in both groups
timeFrame: Daily throughout both menstruations (up to 2 complete menstrual cycles- estimated 60 days)
measure: Quality of Life in both groups
timeFrame: Final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)
measure: Duration and severity of dysmenorrhea in both groups
timeFrame: Final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)
measure: Duration of menstruation in both groups
timeFrame: Final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Five Liters
state: Texas
Study officials:
affiliation: Chief Science Officer
name: Navid Khodaparast, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Senior Director of Clinical Operations
name: Melanie McWade, PhD
role: STUDY_DIRECTOR
References: