Neurostimulation for Heavy Menstrual Bleeding
(VWD/HMB Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
No, you don't have to stop taking your current medications. You must not change any medications or supplements and should continue using them for the duration of the study. You also cannot start any new medications or homeopathic remedies.
What safety data exists for transcutaneous auricular vagus nerve stimulation (taVNS)?
Transcutaneous auricular vagus nerve stimulation (taVNS) is generally considered safe with mild and transient adverse effects. A systematic review and meta-analysis evaluated 177 studies with 6322 subjects and found no significant difference in the risk of adverse events between active taVNS and controls. The most common adverse effects reported were ear pain, headache, and tingling. No severe adverse events were causally linked to taVNS, making it a safe and feasible option for clinical intervention.12345
Is Transcutaneous Auricular Neurostimulation (tAN) a promising treatment for heavy menstrual bleeding?
What data supports the idea that Neurostimulation for Heavy Menstrual Bleeding is an effective treatment?
The available research does not provide specific data supporting the effectiveness of Neurostimulation for Heavy Menstrual Bleeding. Instead, it discusses the use of transcutaneous auricular vagus nerve stimulation (taVNS) for other conditions, such as gastric symptoms and pain management. While taVNS is described as a non-invasive and potentially beneficial treatment for various conditions, there is no direct evidence in the provided information that it is effective for Heavy Menstrual Bleeding.12378
Who Is on the Research Team?
Navid Khodaparast, PhD
Principal Investigator
Chief Science Officer
Melanie McWade, PhD
Principal Investigator
Senior Director of Clinical Operations
Are You a Good Fit for This Trial?
This trial is for regularly menstruating women aged 18-45 with Type 1 von Willebrand Disease who experience heavy menstrual bleeding. Participants must have been on oral birth control for at least three months and agree to maintain their current medication regimen without starting new treatments or homeopathic remedies during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
First Menstruation (Baseline)
Participants estimate blood loss daily and assess dysmenorrhea and quality of life without active tAN treatment
Second Menstruation (Active tAN)
Participants self-administer tAN treatment and estimate blood loss daily, assess dysmenorrhea and quality of life
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Transcutaneous Auricular Neurostimulation (tAN)
Transcutaneous Auricular Neurostimulation (tAN) is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Five Liters, Inc.
Lead Sponsor
Spark Biomedical, Inc.
Industry Sponsor