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

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.