Recruiting

Remote Electrical Stimulation

Sponsor:

Samphire Group, Inc.

Code:

NCT06974773

Conditions

Endometriosis

Eligibility Criteria

Sex: Female

Age: 22 - 45

Healthy Volunteers: Not accepted

Interventions

NettleEndo

Sham NettleEndo Device

Study Details

Brief 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.

Conditions

Endometriosis

Study ID

NCT06974773

Start date

Dec 4, 2025

Status verified date

Dec, 2025

Completion date

Aug 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 22 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Pregnancy/breastfeeding or planning to become pregnant in next 6 months
  • History of epileptic neurological conditions in the immediate family
  • Severe/untreated neurological disease (e.g., epilepsy or seizure disorders, stroke or transient ischemic attack \[TIA\], subarachnoid hemorrhage, traumatic brain injury \[TBI\] with persistent neurological deficits, brain tumors \[malignant or benign\], multiple sclerosis, Parkinson's disease, Alzheimer's disease or other dementias, Huntington's disease, cerebral aneurysms or arteriovenous malformations \[AVMs\], active central nervous system infections \[e.g., meningitis, encephalitis\], hydrocephalus, other neurodegenerative diseases not otherwise specified, or any other neurological condition that, in the opinion of the principal investigator, may increase risk or interfere with study participation or outcomes)
  • Metal implants/electronic devices in brain, head, or neck area
  • Participating in any other clinical trial
  • History of stroke, brain surgery, tumors, head trauma
  • Active skin lesions, open wounds, cuts, or infections on the scalp
  • Active scalp conditions (dermatitis, eczema, psoriasis)
  • Significant scarring/burns/other skin damage on scalp
  • Schizophrenia or bipolar disorder
  • History of suicidal behavior or clinically significant self-injurious behavior (e.g., one or more suicide attempts, non-suicidal self-injury \[NSSI\], or other behaviors indicative of intent to harm oneself), as determined by participant self-report.
  • Treatment plan must be stabilized (≥6 weeks analgesic/ ≥6 months hormonal contraception, and crucially no new medication changes before randomization)
  • Planning to commence any new treatment during intervention period
  • Lack of capacity to consent
  • Participation in a neurotechnology or drug trial in the last 6 months.
  • Recent surgical intervention for endometriosis within 6 months of enrollment or planned surgical intervention for endometriosis during the study period.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

NettleEndo

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Alethios, Inc.

Recruiting

San Francisco, California, United States, 94109

Contacts

Principal Investigator:

Nirav Shah, MD, MPH

More Information

Sponsor

Samphire Group, Inc.

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Keywords

  • Endometriosis
  • Dysmenorrhea
  • Chronic Pelvic Pain
  • tDCS
  • Neuromodulation
  • Women's Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Samphire Group, Inc. on 2025-12-18.