Clinical Trial

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

Study acronym: RELIEF
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated December 18, 2025 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-05-13; most recent amendment 2025-12-10.
Status change: Not Yet Recruiting → Recruiting 2025-05-16
Trial Details
NCT Number NCT06974773
Lead Sponsor Samphire Group, Inc.
Collaborators: Alethios, Inc.
Conditions Endometriosis
Enrollment 120 participants
Start Date 2025-12-04
Primary Completion 2026-07-01 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-18