At-home brain stimulation device tested for endometriosis pelvic pain

Who can take part

• 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

Who cannot take part

• Metal implants/electronic devices in brain, head, or neck area
• Treatment plan must be stabilized (≥6 weeks analgesic/ ≥6 months hormonal contraception, and crucially no new medication changes before randomization)
• 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
• 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)
• 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)
• 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
• Pregnancy/breastfeeding or planning to become pregnant in next 6 months
• Participating in any other clinical trial
• Significant scarring/burns/other skin damage on scalp
• Planning to commence any new treatment during intervention period
• Lack of capacity to consent