Status:
RECRUITING
Remote Electrical Stimulation as a Long-term Intervention for Endometriosis Flare Ups
Lead Sponsor:
Samphire Group, Inc.
Collaborating Sponsors:
Alethios, Inc.
Conditions:
Endometriosis
Eligibility:
FEMALE
22-45 years
Phase:
NA
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 ai...
Detailed Description
This is a decentralized, randomized, double-blind, sham-controlled clinical trial evaluating the efficacy, safety, and usability of the NettleEndo device for managing endometriosis-associated symptoms...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06974773
Start Date
December 4 2025
End Date
August 1 2026
Last Update
December 18 2025
Active Locations (1)
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1
Alethios, Inc.
San Francisco, California, United States, 94109