Phase
Condition
Endometriosis
Treatment
Sham NettleEndo Device
NettleEndo
Clinical Study ID
Ages 22-45 Female
Study Summary
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 onultrasound/MRI
Mean NMPP NRS (non-menstrual pelvic pain) ≥ 2.5 OR ≥1.25 and ≥5 on at least 4 days (self-report)
DYS NRS (dysmenorrhea-related pelvic pain) ≥4 on ≥2 days (self-report)
Access to a smartphone with an internet data plan, phone must be iOS 13.4+, orAndroid 12+.
No hormonal contraception or at least 6 months of consistent adherence to anyhormonal contraception (e.g., IUD, pill, injection)
Regular menstrual cycles (24-35 days) for the past six months
Exclusion
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, strokeor 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 anyother neurological condition that, in the opinion of the principal investigator, mayincrease 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 otherbehaviors indicative of intent to harm oneself), as determined by participantself-report
Treatment plan must be stabilized (4 week analgesic/ 6 month+ hormonalcontraception, and crucially no new medication changes)
Planning to commence any new treatment during intervention period
Lack of capacity to consent
No menstruation
Study Design
Study Description
Connect with a study center
Alethios, Inc.
San Francisco, California 94109
United StatesActive - Recruiting
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