Wearable brain stimulation device for managing endometriosis pain
At-Home Transcranial Direct Current Stimulation (tDCS) Using the NettleEndo Device for Reducing Symptoms of Endometriosis - A Pivotal Double-Blind, Randomized, Placebo-Controlled Clinical Trial
This study tests if a wearable brain stimulation device can help women with endometriosis feel less pain and improve their overall wellbeing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 22 Years to 45 Years |
| Sex | Female |
| Sponsor | Samphire Group, Inc. Industry-sponsored |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06974773 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a wearable brain stimulation device called NettleEndo in reducing chronic pelvic pain and improving overall wellbeing in women with endometriosis. Participants will use the device at home for 20 minutes per session, five times a week over 12 weeks, while being randomly assigned to receive either active or sham stimulation. The study aims to assess pain intensity, mood, sleep quality, and quality of life through self-reported measures collected via a mobile app. The trial is designed as a randomized, double-blind, sham-controlled study to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are women aged 22-45 with a confirmed diagnosis of endometriosis and experiencing significant pelvic pain.
Not a fit: Patients who are pregnant, breastfeeding, or have a history of severe neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly alleviate chronic pelvic pain and enhance the quality of life for women suffering from endometriosis.
How similar studies have performed: While the approach of using transcranial direct current stimulation is gaining interest, this specific application for endometriosis is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Francisco, California
- Alethios, Inc. — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Nirav Shah, MD, MPH
- Study coordinator: Nirav Shah, MD, MPH
- Email: nirav@investigator.alethios.com
- Phone: +1 650-206-8006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.