An interventional study of Volta System in Heavy Menstrual Bleeding, sponsored by Spark Biomedical, Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by Spark Biomedical, Inc. · Not applicable, Interventional, and Treatment
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.
This study is designed as an open label, single arm, cross-over decentralized clinical 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) via the mastoid and the auriculotemporal nerve (ATN) anterior to the tragus. Participants will be enrolled into the study over the course of three consecutive menstrual cycles.
During the First Menstruation (baseline), no tAN treatment will be delivered. Participants will estimate blood loss using the Pictorial Bleeding Assessment Chart (PBAC) daily throughout the duration of the menstruation phase of their menstrual cycle. Menstrual symptoms will be assessed using the Cox Menstrual Symptom Scale (CMSS) and a general quality of life assessment will be conducted on the final day of menstruation using the Short-Form 36 (SF-36).
During the Second Menstruation, participants will self-administer two 1-hour active tAN sessions daily (once in the AM, once in the PM), beginning Day 1 of menstruation through the final day of menstruation. Blood loss will be assessed daily using the PBAC throughout the duration of menstruation. Quality of life will be assessed with the CMSS and SF-36 on the final day of menstruation.
During the Third Menstruation, participants will self-administer a single 2-hour active tAN session each day, beginning Day 1 of menstruation through the final day of menstruation. Blood loss will be assessed daily using the PBAC throughout the duration of menstruation. Quality of life will be assessed with the CMSS and SF-36 on the final day of menstruation.
In addition, a device satisfaction survey will be completed at the end of the study. Participants will exit the study after the final day of their third menstruation.
Exclusion Criteria:
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).
Device: Volta System
The Volta System will be using the components of the Sparrow Ascent device: (FDA-cleared K230796) a wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and/or around the auricle. During the Second and Third Menstruations, participants will self-administer daily active tAN sessions Volta System Device beginning Day 1 of menstruation through the final day of menstruation.
Blood loss
Comparison of mean Pictorial Bleeding Assessment Chart (PBAC) scores during first menstruation (no stimulation) versus second and third menstruations (active stimulation). The PBAC is a widely accepted tool for patients with HMB to account for menstrual blood loss. Menstrual blood loss is estimated through a selection of images of tampons, pads, clots, and flooding events. Patients mark a tally next to the images that best match each of the menstruation products they used that day.
Time frame: Daily throughout all three menstruations (up to 3 complete menstrual cycles - estimated 90 days)
Quality of life
Comparison of mean quality of life score measured by the Short Form 36 (SF-36) during first menstruation (no stimulation) versus second and third menstruations (active stimulation). The SF-36 is a 36-item patient-reported questionnaire that assesses general quality of life. This questionnaire includes eight variables: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy and vitality, pain, and general perception of health. The SF-36 is scored using a standardized scoring algorithm or by the SF-36 scoring software. The SF-36 scores range from 0 to 100, with higher scores representing better health status.
Time frame: Final day of each menstruation (up to 3 complete menstrual cycles - estimated 90 days)
Duration and severity of dysmenorrhea
Comparison of mean Cox Menstrual Symptom Scale (CMSS) scores during first menstruation (no stimulation) versus second and third menstruations (active stimulation). The CMSS measures menstrual distress and dysmenorrhea. The CMSS Severity subscale is an 18-item self-reported scale that measures severity of menstrual symptoms, including pain, nausea, emotions, etc. during menstruation. The CMSS will be used in this trial to measure a participant's dysmenorrhea every day of each menstruation. Each CMSS item is scored from 0-4, with a higher score indicating higher dysmenorrhea severity.
Time frame: Final day of each menstruation (up to 3 complete menstrual cycles - estimated 90 days)
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Spark Biomedical, Inc.