RecruitingNot Applicable

Remote Electrical Stimulation as a Long-term Intervention for Endometriosis Flare Ups

United States120 participantsStarted 2025-12-04

Plain-language summary

The goal of this clinical trial is to learn if a wearable brain stimulation device called NettleEndo can reduce chronic pelvic pain and improve wellbeing in women with endometriosis. The study also aims to assess the safety and usability of the device when used at home over several months. The main questions it aims to answer are: 1. Does at-home transcranial direct current stimulation (tDCS) reduce daily pain intensity in women with endometriosis? 2. Does the device also improve mood and sleep quality? Researchers will compare two groups-one receiving active brain stimulation and one receiving a sham (placebo) stimulation-to see if the active device provides greater improvements in symptoms. Participants will: 1. Use the NettleEndo device at home for 20 minutes per session, five times per week for 12 weeks 2. Be randomly assigned to receive either real or sham stimulation through the device 3. Complete daily and weekly symptom ratings through a mobile app 4. Be followed for 90 days after completing the intervention to monitor longer-term effects All activities are completed remotely using a smartphone app. Participants can contact the study team with questions at any time. The study is double-blind, meaning neither participants nor the researchers assessing outcomes will know who received active or sham treatment until the end of the trial.

Who can participate

Age range

22 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Female, 22-45 years old * Assigned female at birth * Fluent in English * Capacity to consent * Confirmed diagnosis of endometriosis by a qualified physician, via: * Laparoscopic surgery with biopsy-proven endometriosis, OR * Clear evidence of ovarian endometrioma or deep infiltrating endometriosis on ultrasound/MRI * Pain levels: For menstruating participants, all of the following need to be met: * Regular menstrual cycles (21-35 days) * Mean DYS NRS ≥4 during menstrual bleeding days (over the last 28 days, self-assessed) * AND Mean NMPP NRS ≥4 during non-menstrual days (over the last 28 days, self-assessed) For non-menstruating patients, all required: * Irregular/absent cycles OR post-hysterectomy OR surgically menopausal * Mean pelvic pain NRS ≥4 (over the last 28 days, self-assessed) * Pain present on ≥50% of days * Access to a smartphone with an internet data plan, phone must be iOS 13.4+, or Android 12+. * No hormonal contraception or at least 6 months of consistent adherence to any hormonal contraception (e.g., IUD, pill, injection). * Capacity to follow instructions and operate the study device. Exclusion Criteria * Pregnancy/breastfeeding or planning to become pregnant in next 6 months * History of epileptic neurological conditions in the immediate family * Severe/untreated neurological disease (e.g., epilepsy or seizure disorders, stroke or transient ischemic attack \[TIA\], subarachnoid hemorrhage, traumatic brain injury \[TBI\] with pers…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in daily endometriosis-associated pain intensity (NRS)

Timeframe: Daily, throughout the study (6 months)

Trial details

NCT IDNCT06974773

SponsorSamphire Group, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-01

Contact for this trial

Nirav Shah, MD, MPH

+1 650-206-8006 nirav@investigator.alethios.com

View on ClinicalTrials.gov More Endometriosis trials