537: Home-Based Brain Stimulation for Endometriosis-Related Chronic Pelvic Pain: Trial in Progress

Topic: Clinical Science
Subtopic: Pain category (ICD-11), Chronic primary visceral / pelvic pain, Non-pharmacological treatments, Neuromodulation (e.g. TMS, TDCS, FUS, SCS, MCS, DBS, vagus nerve stimulation), Treatment/management

Background and Aims: Endometriosis affects around 10% of reproductive-aged women and commonly causes chronic pelvic pain, alongside dysmenorrhea, dyspareunia, and reduced quality of life. Standard hormonal, analgesic, and surgical approaches can be inadequate or limited by side effects, and many patients continue to experience substantial symptoms. Evidence suggests that altered central pain processing and central sensitization can contribute to persistent pain, creating an unmet need for non-pharmacological treatments that are accessible and scalable. We designed a fully home-based, double-blind, sham-controlled randomized trial to evaluate whether transcranial direct current stimulation (tDCS) can reduce pelvic pain and improve patient-reported functioning in endometriosis population.

Methods: This double-blind, randomized, sham-controlled decentralized trial will enroll 120 women aged 22-45 with physician-confirmed endometriosis and moderate-to-severe pelvic pain, randomized 1:1 to active or sham stimulation. Participants self-administer 20-minute sessions at home, five days per week for three months, followed by three months of follow-up. tDCS stimulation targets the dorsolateral prefrontal cortex and primary motor cortex. Daily diaries capture pelvic pain intensity (dysmenorrhea-related and non-menstrual; 0-10 numerical rating scale). Secondary outcomes include quality of life, clinician global impression, medication use, and dyspareunia. Adherence and safety are monitored via automated session logs and remote adverse-event reporting.

Results: 43 participants have enrolled to date. The study is powered (90%) to detect a clinically meaningful 2-point between-group difference in change in pain at month 3 (standard deviation 3.0; 20% attrition assumed). Co-primary endpoints are the mean change from baseline to month 3 in dysmenorrhea-related pain and non-menstrual pelvic pain. Study success is achieved if at least one endpoint demonstrates superiority with family-wise error control. Recruitment, adherence, and safety indicators will be updated at presentation; efficacy results will follow once all participants complete follow-up.

Conclusions: This trial-in-progress evaluates a scalable, non-invasive, non-pharmacological approach for endometriosis-related abdominal and pelvic pain using rigorous blinding and fully decentralized delivery. Daily symptom capture and automated session logs enable high-resolution characterization of dysmenorrhea-related and non-menstrual pelvic pain, adherence, and safety in real-world use. By targeting cortical circuits implicated in top-down pain modulation and central sensitization, the study may advance understanding of centrally mediated contributors to chronic pelvic pain and expand treatment options for chronic pelvic pain by offering an accessible, home-delivered adjunct to existing medical and surgical care.

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Presenting Author: Ieva Karvelyte
Submitting Author: Ieva Karvelyte

Senior Author: Nirav R. Shah, MD, MPH

IASP 2026 Global Year theme of Neuropathic Pain: No

• Emilė Radytė: PhD - Samphire Neuroscience
• Ieva Karvelyte: MSc - Samphire Neuroscience
• Kathryn EN Ferguson: MPhil - Samphire Neuroscience
• Nirav R. Shah: MD, MPH - Stanford University School of Medicine