NettleEndo for Endometriosis

(RELIEF Trial)

Overseen By Zeenia Framroze, BA MPhil

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Samphire Group, Inc.

Disqualifiers: Pregnancy, Neurological conditions, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

120 Participants Needed

Trial Summary

What is the purpose of this 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. 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.

Research Team

Nirav Shah, MD, MPH

Principal Investigator

Eligibility Criteria

This trial is for women with endometriosis who experience chronic pelvic pain. Participants will use a device at home and track symptoms via an app. They must be willing to follow the study protocol for several months, including daily sessions and symptom tracking.

Inclusion Criteria

Fluent in English

Access to a smartphone with an internet data plan, phone must be iOS 13.4+ or Android 12+

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

Exclusion Criteria

Pregnancy/breastfeeding or planning to become pregnant in the next 6 months

Metal implants/electronic devices in brain, head, or neck area

Participating in any other clinical trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the NettleEndo device at home for 20 minutes per session, five times per week for 12 weeks

12 weeks

Remote monitoring via app

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Remote monitoring via app

Treatment Details

Interventions

• NettleEndo

Trial Overview The NettleEndo device, which provides brain stimulation, is being tested against a sham device to see if it can reduce pain, improve mood, and enhance sleep quality in women with endometriosis over a 12-week period at home.

Participant Groups

Group I: Active tDCS - NettleEndo Device Experimental Treatment 1 Intervention

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.

Group II: Sham tDCS - NettleEndo Device Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Samphire Group, Inc.

Lead Sponsor

Alethios, Inc.

Collaborator