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Neurostimulation

Volta System for Menorrhagia

Dallas, TX

N/A

Recruiting

Research Sponsored by Spark Biomedical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Regularly menstruating female participants between 18-45 years of age

Stable/consistent use of current medications and supplements for the past three months, willingness to continue use for duration of study, and not start any new medications or homeopathic remedies

Must not have

Participant has abnormal ear anatomy or ear infection present

Known inherited or acquired bleeding disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up final day of each menstruation (up to 3 complete menstrual cycles - estimated 90 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial will involve patients with heavy menstrual bleeding receiving a type of nerve stimulation called transcutaneous auricular neurostimulation. The study will last for three menstrual cycles, with participants receiving the neurostim

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Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects of tAN may include discomfort at the stimulation site, headache, dizziness or skin irritation but these are generally mild as it's a non-invasive treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an ear infection or my ear shape is unusual.

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I have a known bleeding disorder.

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I have a diagnosed condition causing heavy periods.

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I have used tobacco or nicotine products in the last three months.

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I have a history of seizures.

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I have a history of brain diseases or injuries.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ final day of each menstruation (up to 3 complete menstrual cycles - estimated 90 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~final day of each menstruation (up to 3 complete menstrual cycles - estimated 90 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and final day of each menstruation (up to 3 complete menstrual cycles - estimated 90 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood loss

Duration and severity of dysmenorrhea

Quality of life

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Volta System

2023

N/A

~30

0 / 8Eligibility criteria met