Neurostimulation for Heavy Menstrual Bleeding
(VWD/HMB Trial)
Recruiting in Palo Alto (17 mi)
Overseen byNavid Khodaparast, PhD
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Five Liters, Inc.
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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 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.
12345What 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.
13567Is 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.
12348Eligibility Criteria
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.
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Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Von Willebrand Disease (VWD) PatientsExperimental Treatment1 Intervention
Participants with VWD Type 1 who are on hormone therapy. First Menstruation (baseline/no active tAN) followed by Second Menstruation (active tAN)
Group II: Heavy Menstrual Bleeding (HMB) PatientsExperimental Treatment1 Intervention
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)
Transcutaneous Auricular Neurostimulation (tAN) is already approved in United States for the following indications:
🇺🇸 Approved in United States as Transcutaneous Auricular Neurostimulation (tAN) for:
- Relief of opioid withdrawal symptoms
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Five LitersDallas, TX
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Who Is Running the Clinical Trial?
Five Liters, Inc.Lead Sponsor
Spark Biomedical, Inc.Industry Sponsor
References
Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. [2020]Non-invasive vagus nerve stimulation (VNS) may be administered via a novel, emerging neuromodulatory technique known as transcutaneous auricular vagus nerve stimulation (taVNS). Unlike cervically-implanted VNS, taVNS is an inexpensive and non-surgical method used to modulate the vagus system. taVNS is appealing as it allows for rapid translation of basic VNS research and serves as a safe, inexpensive, and portable neurostimulation system for the future treatment of central and peripheral disease. The background and rationale for taVNS is described, along with electrical and parametric considerations, proper ear targeting and attachment of stimulation electrodes, individual dosing via determination of perception threshold (PT), and safe administration of taVNS.
High-resolution computational modeling of the current flow in the outer ear during transcutaneous auricular Vagus Nerve Stimulation (taVNS). [2023]Transcutaneous auricular Vagus Nerve Stimulation (taVNS) applies low-intensity electrical current to the ear with the intention of activating the auricular branch of the Vagus nerve. The sensitivity and selectivity of stimulation applied to the ear depends on current flow pattern produced by a given electrode montage (size and placement).
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 vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique. Several studies have reported the effectiveness of taVNS in patients with disorders of consciousness (DOC); however, differences in the modulation paradigm have led to inconsistent treatment outcomes.
Transcutaneous auricular VNS applied to experimental pain: A paired behavioral and EEG study using thermonociceptive CO2 laser. [2021]Transcutaneous auricular Vagal Nerve Stimulation (taVNS) is a non-invasive neurostimulation technique with potential analgesic effects. Several studies based on subjective behavioral responses suggest that taVNS modulates nociception differently with either pro-nociceptive or anti-nociceptive effects.
Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping. [2023]Transcutaneous auricular vagus nerve stimulation (TaVNS) is a supplementary treatment for gastric symptoms resulting from dysrhythmias. The main objective of this study was to quantify the effects of 10, 40, and 80 Hz TaVNS and sham in healthy individuals in response to a 5-minute water-load (WL5) test.
[Clinical Application of Transcutaneous Auricular Vagus Nerve Stimulation]. [2022]Transcutaneous auricular vagus nerve stimulation (taVNS) refers to stimulation of the vagus nerve through the skin of the left cymba conchae and is a unique strategy that is investigated as a useful therapeutic approach for a variety of conditions including epilepsy, depression, cardiac diseases, tinnitus, and migraine. A randomized double-blind clinical trial was performed in patients with drug-resistant epilepsy. Although several pilot studies were performed before this trial and showed that taVNS was safe, well tolerated, and feasible for long-term treatment, no statistically significant difference was observed between the high- and low-stimulation groups, and further studies are warranted to gain a deeper understanding of this subject. A tingling sensation or pain at the site of stimulation is the most common adverse effect associated with taVNS. Therefore, intermittent stimulation, ranging from 30 minutes to several hours, is provided during each session several times a day. Currently, taVNS is not approved for insurance coverage by the Japan Ministry of Health, Labour, and Welfare. Further studies and investigations are necessary in the near future.
Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]Transcutaneous auricular vagus nerve stimulation (taVNS) has been investigated as a novel neuromodulation tool. Although taVNS is generally considered safe with only mild and transient adverse effects (AEs), those specifically caused by taVNS have not yet been investigated. This systematic review and meta-analysis on taVNS aimed to (1) systematically analyze study characteristics and AE assessment, (2) characterize and analyze possible AEs and their incidence, (3) search for predictable risk factors, (4) analyze the severity of AE, and (5) suggest an evidence-based taVNS adverse events questionnaire for safety monitoring. The articles searched were published through April 7, 2022, in Medline, Embase, Web of Science, Cochrane, and Lilacs databases. In general, we evaluated 177 studies that assessed 6322 subjects. From these, 55.37% of studies did not mention the presence or absence of any AEs; only 24.86% of the studies described that at least one adverse event occurred. In the 35 studies reporting the number of subjects with at least one adverse event, a meta-analytic approach to calculate the risk differences of developing an adverse event between active taVNS and controls was used. The meta-analytic overall adverse events incidence rate was calculated for the total number of adverse events reported on a 100,000 person-minutes-days scale. There were no differences in risk of developing an adverse event between active taVNS and controls. The incidence of AE, in general, was 12.84/100,000 person-minutes-days of stimulation, and the most frequently reported were ear pain, headache, and tingling. Almost half of the studies did not report the presence or absence of any AEs. We attribute this to the absence of AE in those studies. There was no causal relationship between taVNS and severe adverse events. This is the first systematic review and meta-analysis of transcutaneous auricular stimulation safety. Overall, taVNS is a safe and feasible option for clinical intervention.
Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. [2022]As an emerging neuromodulation therapy, transcutaneous auricular vagus nerve stimulation (taVNS) has been proven to be safe and effective for epilepsy, major depressive disorders, insomnia, glucose metabolic disorders, pain, stroke, post stroke rehabilitation, anxiety, fear, cognitive impairment, cardiovascular disorders, tinnitus, Prader-Willi Syndrome, and COVID-19.