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Thank you for attending THSNA 2026. The virtual meeting is now closed.
Thank you for attending THSNA 2026. The virtual meeting is now closed.
Presentation Details
| Optimizing Transcutaneous Auricular Neurostimulation Therapy for Heavy Menstrual Bleeding: an Open Label Trial Christopher J.Czura1, Angela C.Weyand2, Maureen K.Baldwin3, Michael Recht4, 5, Caroline Benner1, Kimiko Harada1, Brooke Wade1, Meghan Luellen1, Melanie A.McWade1, Alejandro Covalin1, Navid Khodaparast1. 1Spark Biomedical, Inc., Dallas, TX, USA.2University of Michigan Medical School, Ann Arbor, MI, USA.3Oregon Health Sciences University, Portland, OR, USA.4Yale School of Medicine, New Haven, CT, USA |
Abstract
Background: The neural tourniquet is an efferent function of the vagus nerve that modulates platelet phenotype in the spleen and improves hemostasis. Electrical stimulation of the vagus nerve reduces traumatic blood loss in models of soft tissue injury. Transcutaneous auricular neurostimulation (tAN) targeting vagus and trigeminal nerve branches on and around the ear was recently shown to improve symptoms of heavy menstrual bleeding (HMB), including menstrual blood loss (MBL). This study was conducted to optimize the tAN therapy paradigm to reduce MBL in women with HMB. Methods: Participants with a history of HMB of unknown cause gave informed consent to participate in this IRB-approved, decentralized, open-label pilot trial (NCT06814028). The device included a novel electrode configuration through which the auricular branch of the vagus nerve (ABVN) was targeted posterior to the auricle, near the mastoid process; stimulation was also applied to the auriculotemporal nerve (ATN), anterior to the tragus (Fig. 1). Participants were followed for three consecutive menstrual cycles, during which estimated daily blood loss using a validated pictorial blood loss assessment chart (PBAC) and menstrual symptoms using the Cox Menstrual Symptom Scale (CMSS) were recorded. During the first menstruation, baseline PBAC and CMSS scores were obtained without the use of tAN. During the second menstruation, participants self-administered two 1-hour sessions of tAN daily throughout menstruation; during the third menstruation, participants self-administered one 2-hour session of tAN daily throughout menstruation. The PBAC was also used to calculate the duration of each menstruation. Student’s paired T-test was used to compare mean outcome scores to baseline. Results: Use of tAN for one hour twice per day was associated with 29% lower PBAC scores and reduced duration of menstruation by 10% as compared with baseline (Fig. 2). Use of tAN for two hours once per day was associated with 48% lower PBAC scores and reduced duration of menstruation by 21% as compared with baseline (Fig. 2). Notably, participants reported a 31% improvement in menstrual symptoms during the first treatment menstruation, and 68% improvement during the second treatment menstruation. Conclusions: These pilot results suggest that application of tAN for a 2-hour session daily during menstruation is effective, safe and feasible for reducing menstrual symptoms in women with HMB.
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No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the author.