Wearable brain stimulation device for managing endometriosis pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing different techniques to treat endometriosis

  This study is testing different methods to treat endometriosis, like laser and heat techniques, to see which one works best for relieving pain in women who are already having surgery for the condition.

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• Postoperative Pain Trajectories After Endometriosis Surgery

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• Imaging endometriosis with a special PET tracer in adult women

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• Fiber supplement for digestive symptoms in endometriosis

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• Stellate ganglion block and dexmedetomidine for better sleep after gynecologic laparoscopy

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• Atypical Endometriosis: Histology, Immunophenotype and Molecular Features

  Researchers will look at how endometriotic tissue that looks atypical under the microscope relates to clinical features and ultrasound findings to better separate benign from potentially atypical lesions.

  Recruiting Casa di Cura Dott. Pederzoli · Peschiera del Garda, Verona · NCT07816133

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.