At-Home Transcranial Direct Current Stimulation (tDCS) Using the NettleEndo Device for Reducing Symptoms of Endometriosis - A Pivotal Double-Blind, Randomized, Placebo-Controlled Clinical Trial
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.
• 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.