Volta System for Menorrhagia

Overseen By Kimi Harada

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Spark Biomedical, Inc.

Must not be taking: Anticoagulants, Antifibrinolytics, Hormone therapy, others

Disqualifiers: Pregnancy, Lactating, Neurologic diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for women with heavy menstrual bleeding of unknown cause. The treatment, Transcutaneous Auricular Neurostimulation, uses a device to stimulate specific nerves in the ear, potentially reducing heavy bleeding during menstruation. Participants will use the device daily during two menstrual cycles, following a baseline cycle without it, to assess improvement. Women with heavy periods who are not currently on hormonal treatments may be suitable candidates for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for heavy menstrual bleeding.

Will I have to stop taking my current medications?

No, you won't have to stop taking your current medications. The trial requires that you continue using your current medications and supplements consistently throughout the study.

What prior data suggests that this method is safe for treating heavy menstrual bleeding?

Research has shown that transcutaneous auricular neurostimulation (tAN) is generally safe. In a previous study, women using tAN for heavy menstrual bleeding experienced less bleeding without major side effects. Early research also suggests that this procedure is safe, with few negative effects reported. This non-invasive treatment works by gently stimulating nerves in the ear. While more studies are needed, current evidence supports tAN as a safe option for women with heavy menstrual bleeding. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcutaneous Auricular Neurostimulation (tAN) is unique because it offers a non-hormonal approach to managing heavy menstrual bleeding (HMB), which is a departure from the usual reliance on hormonal treatments like birth control pills or IUDs. Researchers are excited about tAN because it uses a novel delivery method: stimulating the nerves in the ear to potentially regulate menstrual flow. This method could provide a new option for those who cannot use hormonal therapies, offering a more targeted and perhaps faster-acting solution without altering hormone levels.

What evidence suggests that transcutaneous auricular neurostimulation is effective for heavy menstrual bleeding?

Research has shown that transcutaneous auricular neurostimulation (tAN), a treatment participants in this trial will receive, might help reduce heavy menstrual bleeding. Early studies found that tAN can lower menstrual blood loss in individuals with heavy periods, including those with von Willebrand disease, a bleeding disorder. This treatment targets nerves in the ear. Initial results are promising, suggesting it could alleviate symptoms, but further research is needed to confirm these findings. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for women experiencing heavy menstrual bleeding without a known cause. Participants will be involved over three menstrual cycles, including one baseline cycle and two with daily neurostimulation treatment.

Inclusion Criteria

I am a woman aged 18-45 and have regular menstrual cycles.

I haven't changed my medications or supplements in the last 3 months and won't start new ones during the study.

I am willing to use the same brand of tampons or pads for the study.

Exclusion Criteria

I have a known bleeding disorder.

I have a diagnosed condition causing heavy periods.

I use menstrual cups or menstrual underwear for my periods.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Menstruation

Participants estimate blood loss using the PBAC and assess menstrual symptoms using the CMSS without active tAN treatment

1 menstrual cycle

Daily self-assessment

Second Menstruation

Participants self-administer two 1-hour active tAN sessions daily and assess blood loss and quality of life

1 menstrual cycle

Daily self-administration and assessment

Third Menstruation

Participants self-administer a single 2-hour active tAN session daily and assess blood loss and quality of life

1 menstrual cycle

Daily self-administration and assessment

Follow-up

Participants complete a device satisfaction survey and exit the study

End of third menstruation

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Auricular Neurostimulation

Trial Overview

The study tests transcutaneous auricular neurostimulation (tAN) using the Volta System. It targets specific nerves in the ear to potentially treat heavy menstrual bleeding by applying stimulation during menstruation.

How Is the Trial Designed?

Group I: Heavy Menstrual Bleeding Patients Experimental Treatment 1 Intervention

Participants with no known cause of HMB who are not on hormonal therapy. First Menstruation (baseline/no active tAN) followed by Second Menstruation (2 one-hour active tAN sessions daily) followed by Third Menstruation (1 two-hour active tAN session daily).

Who Is Running the Clinical Trial?

Spark Biomedical, Inc.

Lead Sponsor

Trials

14

Recruited

560+

Five Liters, Inc.

Industry Sponsor

Trials

3

Recruited

70+

Published Research Related to This Trial

In a double-blind trial involving 231 women, estradiol valerate/dienogest (E(2)V/DNG) significantly reduced menstrual blood loss by an average of 69.4%, compared to only 5.8% in the placebo group, indicating its strong efficacy for treating heavy menstrual bleeding.

E(2)V/DNG also improved iron metabolism parameters, suggesting additional health benefits, although some participants experienced adverse events, with headaches being the most common.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective treatment of heavy and/or prolonged menstrual bleeding with an oral contraceptive containing estradiol valerate and dienogest: a randomized, double-blind Phase III trial. Fraser, IS., Römer, T., Parke, S., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Auricular stimulation (AS) has been shown to significantly reduce heart rate (HR) and alter heart rate variability (HRV) by decreasing the LF/HF ratio, indicating increased vagal activity, based on a systematic review of 78 trials.

The reduction in HR from AS is considered clinically safe, with only minor side effects reported, suggesting potential for further research into its use for managing conditions like tachycardia or autonomic imbalance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular effects of auricular stimulation -a systematic review and meta-analysis of randomized controlled clinical trials. Hua, K., Cummings, M., Bernatik, M., et al.[2023]

Using 7T fMRI, the study found that transcutaneous auricular vagus nerve stimulation (taVNS) applied during exhalation (eRAVANS) significantly increased brain activity in areas associated with autonomic regulation, particularly the nucleus tractus solitarii (NTS), compared to stimulation during inhalation (iRAVANS).

eRAVANS not only enhanced brainstem responses but also improved cardiovagal modulation, indicating that the timing of taVNS application can optimize its effects on both central nervous system activity and heart rate regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of respiration on brainstem and cardiovagal response to auricular vagus nerve stimulation: A multimodal ultrahigh-field (7T) fMRI study. Sclocco, R., Garcia, RG., Kettner, NW., et al.[2020]

The NovaSure endometrial ablation system is a safe and effective treatment for severe dysfunctional uterine bleeding (DUB), with no complications reported during or after the procedure in a study of 107 premenopausal women.

After 12 months, 58% of participants experienced amenorrhea, indicating a significant reduction in menstrual bleeding, and the procedure was completed in an average of just 94 seconds without the need for endometrial pretreatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NovaSure impedance-controlled system for endometrial ablation. Gallinat, A., Nugent, W.[2022]

Transcutaneous vagus nerve stimulation (tVNS) significantly reduced postural tachycardia in patients with POTS, showing a mean heart rate increase of 17.6 beats/min in the active group compared to 31.7 beats/min in the sham group after 2 months.

tVNS also led to lower levels of antiadrenergic autoantibodies and inflammatory cytokines, along with improved heart rate variability, indicating its potential as a safe and effective noninvasive treatment for POTS without any reported side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Vagus Nerve Stimulation in Postural Tachycardia Syndrome: A Randomized Clinical Trial. Stavrakis, S., Chakraborty, P., Farhat, K., et al.[2023]

Transcutaneous stimulation of the auricular branch of the vagal nerve (t-VNS) at 1 Hz significantly reduced headache days in chronic migraine patients, with an average reduction of 7 days compared to 3.3 days in the 25 Hz group, indicating greater efficacy at the lower frequency.

The treatment was found to be safe, with no serious adverse events reported, and both treatment groups showed significant improvements in headache-related disability, suggesting that t-VNS is a promising option for managing chronic migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial. Straube, A., Ellrich, J., Eren, O., et al.[2022]

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe, with a low incidence of mild and transient adverse effects, such as ear pain, headache, and tingling, reported in only 24.86% of the studies analyzed.

In a systematic review of 177 studies involving 6322 subjects, there was no significant difference in the risk of adverse events between taVNS and control groups, indicating that taVNS is a feasible option for clinical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Kim, AY., Marduy, A., de Melo, PS., et al.[2023]

In a 7-year follow-up study of 75 premenopausal women, the NovaSure endometrial ablation system demonstrated high efficacy, with 97.1% of patients reporting amenorrhea and 100% achieving a significant reduction in menstrual bleeding.

The procedure was found to be safe, with no intra or postoperative complications, and only 8% of patients requiring further surgical intervention, indicating a 92% avoidance rate of additional surgeries over the follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NovaSure impedance controlled endometrial ablation: long-term follow-up results. Fulop, T., Rákóczi, I., Barna, I.[2022]

A survey of 1866 women in Western Kenya revealed that a high percentage of users experienced menstrual bleeding problems with injectables (69%-79%) and implants (55%-60%), which negatively impacted their satisfaction and likelihood of future use.

Heavy menstrual bleeding was particularly detrimental to method evaluations among past users, highlighting the need for better counseling and information on contraceptive side effects to improve user satisfaction and reduce discontinuation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which contraceptive side effects matter most? Evidence from current and past users of injectables and implants in Western Kenya. Odwe, G., Obare, F., Machiyama, K., et al.[2022]

The NovaSure Global Endometrial Ablation (GEA) system was found to be a safe and effective treatment for severe menorrhagia due to dysfunctional uterine bleeding, with no serious complications reported during the procedure.

After 12 months, 58% of the 46 women treated experienced complete cessation of uterine bleeding (amenorrhea), indicating significant efficacy of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endometrial ablation with NovaSure GEA, a pilot study. Busund, B., Erno, LE., Grønmark, A., et al.[2022]

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