29 Participants Needed

Neurostimulation for Heavy Menstrual Bleeding

(VWD/HMB Trial)

CB
BL
KH
Overseen ByKimiko Harada
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Five Liters, Inc.
Must be taking: Hormone therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

Yes, Transcutaneous Auricular Neurostimulation (tAN) is a promising treatment because it is non-invasive, safe, and has been effective for various conditions like pain, anxiety, and depression. It is also inexpensive and portable, making it accessible for future treatments.13678

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?

NK

Navid Khodaparast, PhD

Principal Investigator

Chief Science Officer

MM

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

I have been diagnosed with von Willebrand Disease Type 1.
I haven't changed my medications or supplements in the last 3 months and won't start new ones during the study.
I am a woman aged 18-45 and have regular menstrual cycles.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

First Menstruation (Baseline)

Participants estimate blood loss daily and assess dysmenorrhea and quality of life without active tAN treatment

1 menstrual cycle (estimated 30 days)
Daily self-assessment

Second Menstruation (Active tAN)

Participants self-administer tAN treatment and estimate blood loss daily, assess dysmenorrhea and quality of life

1 menstrual cycle (estimated 30 days)
Daily self-administration and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Transcutaneous Auricular Neurostimulation (tAN)
Trial Overview The study tests if transcutaneous auricular neurostimulation (tAN) using the Volta System can help manage heavy menstrual bleeding, improve quality of life, and reduce pain in patients with von Willebrand Disease during their menstrual cycle.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Von Willebrand Disease (VWD) PatientsExperimental Treatment1 Intervention
Group II: Heavy Menstrual Bleeding (HMB) PatientsExperimental Treatment1 Intervention

Transcutaneous Auricular Neurostimulation (tAN) is already approved in United States for the following indications:

🇺🇸
Approved in United States as Transcutaneous Auricular Neurostimulation (tAN) for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Five Liters, Inc.

Lead Sponsor

Trials
3
Recruited
70+

Spark Biomedical, Inc.

Industry Sponsor

Trials
14
Recruited
560+

Published Research Related to This Trial

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive and cost-effective method for modulating the vagus nerve, making it a promising alternative to traditional surgical vagus nerve stimulation.
taVNS allows for easy and safe administration, with considerations for proper electrode placement and individual dosing based on perception thresholds, which enhances its potential for treating various central and peripheral diseases.
Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations.Badran, BW., Yu, AB., Adair, D., et al.[2020]
Transcutaneous auricular Vagus Nerve Stimulation (taVNS) can be optimized by varying electrode designs, which significantly affects the sensitivity and selectivity of nerve activation in different regions of the ear, as shown through a detailed anatomical model and finite element analysis.
The study found that smaller electrodes increase the electric field strength for a given current, allowing for more targeted stimulation of specific ear regions, which is crucial for enhancing the efficacy of taVNS in clinical applications.
High-resolution computational modeling of the current flow in the outer ear during transcutaneous auricular Vagus Nerve Stimulation (taVNS).Kreisberg, E., Esmaeilpour, Z., Adair, D., et al.[2023]
This study will investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on 15 patients with a minimally conscious state, using five different frequencies (1, 10, 25, 50, and 100 Hz) to determine the optimal stimulation parameters.
The goal is to achieve stable improvements in consciousness levels in patients with disorders of consciousness by optimizing the taVNS neuromodulation technique, with results measured through the coma recovery scale-revised (CRS-R) and resting EEG assessments.
Optimizing the modulation paradigm of transcutaneous auricular vagus nerve stimulation in patients with disorders of consciousness: A prospective exploratory pilot study protocol.Zhai, W., Jiao, H., Zhuang, Y., et al.[2023]

Citations

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. [2020]
High-resolution computational modeling of the current flow in the outer ear during transcutaneous auricular Vagus Nerve Stimulation (taVNS). [2023]
Optimizing the modulation paradigm of transcutaneous auricular vagus nerve stimulation in patients with disorders of consciousness: A prospective exploratory pilot study protocol. [2023]
Transcutaneous auricular VNS applied to experimental pain: A paired behavioral and EEG study using thermonociceptive CO2 laser. [2021]
Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping. [2023]
[Clinical Application of Transcutaneous Auricular Vagus Nerve Stimulation]. [2022]
Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]
Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. [2022]
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