Over-the-ear device eases heavy menstrual bleeding, pain in trial
Electrical stimulation of nerves reduces bleeding in those with, without VWD
Electrical stimulation of nerves that control automatic bodily functions, administered twice daily through a device worn over the ear, may help control heavy menstrual bleeding in people with and without von Willebrand disease (VWD), according to results from a small clinical trial.
The study, “Transcutaneous auricular neurostimulation to reduce heavy menstrual bleeding in women with and without von Willebrand disease,” was published in Frontiers in Medicine. The work was funded by Pathway to Cures, the venture philanthropy arm of the National Bleeding Disorders Foundation, and it was led by scientists at Spark Biomedical, the company developing the electrical stimulation devices used in the trial.
Heavy menstrual bleeding is a common issue, affecting roughly 16 million people in the U.S. alone. Excessive blood loss during periods is especially common among people with bleeding disorders such as VWD. In this study, the researchers defined heavy menstrual bleeding as “blood loss that requires changing pads/tampons every 2 h or less, requiring more than one pad/tampon at a time, frequent passing of clots or flooding events, or periods lasting 8 days or more.”
The vagus nerve is a large nerve that runs from the head to other parts of the body and plays a key role in controlling unconscious bodily functions. Recent research has indicated that electrically stimulating the vagus nerve can boost the activity of platelets, cell fragments that help blood clot. Theoretically, this type of increased clotting activity could help prevent excessive blood loss during menstruation.
To explore this idea, the researchers conducted a small clinical trial (NCT06064851) to investigate the use of transcutaneous auricular neurostimulation (tAN) as a method for controlling heavy menstrual bleeding. tAN uses a device worn over the ear to stimulate the vagus nerve as well as the trigeminal nerve, which also helps regulate autonomic (unconscious) bodily functions.
“By targeting the vagus and trigeminal nerves through auricular stimulation, tAN provides a comprehensive, non-pharmacological and non-invasive solution for managing a wide range of menstrual symptoms, from heavy bleeding and cramping pain to mood changes, gastrointestinal discomfort, and associated autonomic disruptions,” the researchers wrote.
Researchers note ‘promising findings’
The trial enrolled 16 women who reported heavy menstrual bleeding. Eight of the participants had VWD; the others had heavy bleeding of unknown cause.
Over the course of the trial, the women used a validated, picture-based chart to estimate their blood loss over the course of two menstrual periods. For one period, the women simply tracked their blood loss. During the other period, the women were administered tAN in hour-long sessions twice daily.
Results indicated that tAN reduced menstrual blood loss by a mean of 57% in the women with VWD, with similar findings also in women with heavy menstrual bleeding of unknown cause. The researchers described this change as “a clinically meaningful result.” The duration of menstruation was also reduced, by a mean of nearly 20%.
In questionnaires, the women reported that tAN was associated with a notable reduction in the severity of menstrual symptoms such as cramp pain. Women with VWD also reported improvements in measures of health-related quality of life, noting that tAN allowed them to be more active and mobile. This benefit was also noted by participants without VWD, though to a lesser extent.
“Notably, participants reported spending 30–50% less extra time in bed due to menstrual symptoms,” the researchers wrote. “These promising findings are the first in human therapeutic application of tAN to improve menstrual health.”
The tAN intervention was also generally well tolerated. Some women reported mild skin irritation around the ear, but these all resolved without medical intervention, and no other side effects were noted after tAN was administered.
The scientists emphasized that this was a small trial that only tested tAN during one menstrual cycle, and there wasn’t a sham group to control for the placebo effect. Further studies will be needed to validate the results, they said.
“Future studies should include larger sample sizes, blinded and sham-controlled arms, treatment during multiple consecutive menstruations, stratification by bleeding etiology [underlying cause], and incorporation of laboratory-based assessments of coagulation and platelet function,” the scientists wrote.
Spark recently secured funding to launch another clinical trial further testing tAN to control menstrual bleeding in women with VWD.
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