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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. Wear an optional fitness tracker to collect data on sleep, movement, and heart rate variability 5. Be followed for 60 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 22
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

• Mean NMPP NRS (non-menstrual pelvic pain) ≥ 2.5 OR ≥1.25 and ≥5 on at least 4 days (self-report)

• DYS NRS (dysmenorrhea-related pelvic pain) ≥4 on ≥2 days (self-report)

• 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)

• Regular menstrual cycles (24-35 days) for the past six months

Locations
United States
California
Alethios, Inc.
RECRUITING
San Francisco
Contact Information
Primary
Nirav Shah, MD, MPH
nirav@investigator.alethios.com
+1 650-206-8006
Backup
Zeenia Framroze, BA MPhil
support@alethios.com
Time Frame
Start Date: 2025-06-08
Estimated Completion Date: 2026-02-05
Participants
Target number of participants: 120
Treatments
Experimental: Active tDCS - NettleEndo Device
Participants assigned to this arm will receive active transcranial direct current stimulation (tDCS) using the NettleEndo wearable device. The device delivers 2 mA of stimulation for 20 minutes per session, five sessions per week, for a total of 12 weeks. Stimulation is delivered over the left primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC) using pre-programmed settings. Participants complete all sessions at home and log outcomes via a mobile app. Device use is monitored remotely through digital logs.
Sham_comparator: Sham tDCS - NettleEndo Device
Participants assigned to this arm will receive sham transcranial direct current stimulation (tDCS) using the NettleEndo wearable device. The device mimics the sensation of active stimulation by ramping up to 2 mA for 20 seconds before turning off, with no therapeutic current delivered for the remainder of the 20-minute session. Participants use the device five times per week for 12 weeks. Sessions are completed at home, and outcome measures are recorded via a mobile app. Device use is remotely monitored via app-based logging. Participants and investigators are blinded to group allocation.
Related Therapeutic Areas
Sponsors
Collaborators: Alethios, Inc.
Leads: Samphire Group, Inc.

This content was sourced from clinicaltrials.gov