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New treatment option for Endometriosis
Official title Remote Electrical Stimulation as a Long-term Intervention for Endometriosis Flare Ups
ClinicalTrials.gov ID: NCT06974773
What this study is testing
- What it's testing
- 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 aims to assess the safety and usability of the device when used at home over several months.
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 45, women only
You may be able to join if
- Female, 22-45 years old
- Assigned female at birth
- Fluent in English
- Capacity to consent
- Confirmed diagnosis of endometriosis by a qualified physician, via:
You likely can't join if
- 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...
- Metal implants/electronic devices in brain, head, or neck area
- Participating in any other clinical trial
- History of stroke, brain surgery, tumors, head trauma
See the full eligibility 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 22 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.