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Remote Electrical Stimulation for Endometriosis Pain

This study is testing if a portable device called NettleEndo can help reduce chronic pelvic pain and improve well-being for women with endometriosis. The NettleEndo device delivers a low-level electrical current to specific brain areas. Researchers want to see if using this device at home for several months is safe and effective in lowering daily pain intensity. They will also look at whether it improves mood and sleep. You might be able to join if you are a woman between 22 and 45 years old, have a confirmed diagnosis of endometriosis, and are fluent in English. The study compares the NettleEndo device to a "sham" (placebo) device to see if the active treatment works better. The current recruitment status is unclear.

Study design
This is a randomized, double-blind study with 120 planned participants. Participants will be assigned by chance to receive either active NettleEndo stimulation or a sham (inactive) version of the device.
What's involved
You would use the NettleEndo device at home for 20 minutes per session, five sessions per week, over 12 weeks. You will also complete questionnaires through a mobile app.
Compensation
Not stated in the trial record.
Follow-up
After the 12-week treatment period, there will be a 90-day follow-up phase to track your progress.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06974773

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

Recruiting
NAAges 22–45InterventionalTreatment
Samphire Group, Inc.
~120 participants
Updated 2025-12-18 on ClinicalTrials.gov
What's tested:NettleEndoSham NettleEndo Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in daily endometriosis-associated pain intensity (NRS)
Measured over Daily, throughout the study (6 months)

Conditions

Endometriosis

Explore related trials

DysmenorrheaEndometriosisPelvic Pain

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Nirav Shah, MD, MPH · PRINCIPAL_INVESTIGATOR

Who to contact

Nirav Shah, MD, MPH
[email protected]
+1 650-206-8006
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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)
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

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.

What this trial measures

  • Change in daily endometriosis-associated pain intensity (NRS)Daily, throughout the study (6 months)

    Average change from baseline in daily self-reported pain intensity related to endometriosis, using a 0-10 Numerical Rating Scale (NRS). This will be measured separately for dysmenorrhea (Dysmenorrhea NRS; DYS NRS) and non-menstrual pelvic pain (Non-Menstrual Pelvic Pain; NMPP NRS). Collected via mobile app. A decrease in NRS, NMPP NRS and DYS NRS scores indicate a better outcome, as it reflects reduced pain intensity.