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

Part of paid clinical trials in San Francisco, California.

Sponsor
Samphire Group, Inc.
Study ID
NCT06974773
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
22 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • NettleEndo — DEVICE
    The NettleEndo device is a portable, home-use transcranial direct current stimulation (tDCS) system designed to deliver low-intensity electrical stimulation to targeted brain regions. The device delivers a constant current of 2 mA in the active stimulation group, targeting the left primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC) through pre-set electrode positioning.
  • Sham NettleEndo Device — DEVICE
    The sham version of the NettleEndo device is visually identical to the active device and is used under the same schedule. The device is pre-programmed to deliver a brief 2 mA current for 20 seconds at the beginning of each session to mimic the initial skin sensations of active stimulation, after which no current is delivered for the remainder of the session. This allows participants to remain blinded to their group assignment. The device is used with the same electrode positioning as the active version.

Study Details

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.

Key Dates

Start date
Dec 4, 2025
Status verified
Dec 2025
Primary completion
Jul 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in daily endometriosis-associated pain intensity (NRS) [ Time Frame: Daily, throughout the study (6 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Alethios, Inc.San FranciscoCalifornia94109
Zeenia Framroze, BA MPhil
[email protected]
+1 650-206-8006
Nirav Shah, MD, MPH
[email protected]
+1 650-206-8006
Nirav Shah, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
Alethios, Inc.· San Francisco, CA

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