15 Participants Needed

Volta System for Menorrhagia

KH
Overseen ByKimi Harada
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Transcutaneous Auricular Neurostimulation for menorrhagia?

Research shows that transcutaneous auricular vagus nerve stimulation (taVNS) is safe and has been effective in treating conditions like chronic migraine and postural tachycardia syndrome, suggesting it may also help with menorrhagia.12345

Is the Volta System for Menorrhagia safe for humans?

The NovaSure system, which is used for endometrial ablation in women with heavy menstrual bleeding, has been studied for safety and shows long-term safety in humans. Although this is not the same as the Volta System, it provides some insight into the safety of similar treatments.678910

How is the Volta System for Menorrhagia treatment different from other treatments?

The Volta System uses transcutaneous auricular neurostimulation, which involves applying a low-intensity electrical current to the ear to stimulate the vagus nerve. This method is unique because it is non-invasive and targets the nervous system, unlike traditional treatments that may involve medication or surgery.123511

What is the purpose of this trial?

This study is designed as an open label, single-arm, decentralized research study in which patients with idiopathic heavy menstrual bleeding will receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN). Participants will be enrolled over the course of three menstruations: one baseline menstruation and two menstruations with added daily neurostimulation.

Eligibility Criteria

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.
See 2 more

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.
See 14 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Heavy Menstrual Bleeding 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 (2 one-hour active tAN sessions daily) followed by Third Menstruation (1 two-hour active tAN session daily).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Spark Biomedical, Inc.

Lead Sponsor

Trials
14
Recruited
560+

Five Liters, Inc.

Industry Sponsor

Trials
3
Recruited
70+

Findings from Research

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

References

Cardiovascular effects of auricular stimulation -a systematic review and meta-analysis of randomized controlled clinical trials. [2023]
Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]
Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial. [2022]
Noninvasive Vagus Nerve Stimulation in Postural Tachycardia Syndrome: A Randomized Clinical Trial. [2023]
High-resolution computational modeling of the current flow in the outer ear during transcutaneous auricular Vagus Nerve Stimulation (taVNS). [2023]
NovaSure impedance controlled endometrial ablation: long-term follow-up results. [2022]
Which contraceptive side effects matter most? Evidence from current and past users of injectables and implants in Western Kenya. [2022]
Endometrial ablation with NovaSure GEA, a pilot study. [2022]
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. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
NovaSure impedance-controlled system for endometrial ablation. [2022]
11.United Statespubmed.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. [2020]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security