Actively Recruiting
Remote Electrical Stimulation as a Long-term Intervention for Endometriosis Flare Ups
Led by Samphire Group, Inc. · Updated on 2025-12-18
120
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
S
Samphire Group, Inc.
Lead Sponsor
A
Alethios, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. The main questions it aims to answer are: 1. Does at-home transcranial direct current stimulation (tDCS) reduce daily pain intensity in women with endometriosis? 2. Does the device also improve mood and sleep quality? Researchers will compare two groups-one receiving active brain stimulation and one receiving a sham (placebo) stimulation-to see if the active device provides greater improvements in symptoms. Participants will: 1. Use the NettleEndo device at home for 20 minutes per session, five times per week for 12 weeks 2. Be randomly assigned to receive either real or sham stimulation through the device 3. Complete daily and weekly symptom ratings through a mobile app 4. Be followed for 90 days after completing the intervention to monitor longer-term effects All activities are completed remotely using a smartphone app. Participants can contact the study team with questions at any time. The study is double-blind, meaning neither participants nor the researchers assessing outcomes will know who received active or sham treatment until the end of the trial.
CONDITIONS
Official Title
Remote Electrical Stimulation as a Long-term Intervention for Endometriosis Flare Ups
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, 22-45 years old
- Assigned female at birth
- Fluent in English
- Able to consent to participate
- Confirmed endometriosis diagnosis by laparoscopic surgery with biopsy or clear evidence on ultrasound/MRI
- For menstruating women: regular cycles (21-35 days), pain scores of 4 or higher during menstruation and non-menstrual days
- For non-menstruating women: irregular/absent cycles, post-hysterectomy, or surgically menopausal with pelvic pain score of 4 or higher present at least 50% of days
- Access to a smartphone with internet and iOS 13.4+ or Android 12+ operating system
- No hormonal contraception or consistent use for at least 6 months
- Able to follow instructions and operate the study device
You will not qualify if you...
- Pregnancy, breastfeeding, or planning pregnancy within 6 months
- Family history of epileptic neurological conditions
- Severe or untreated neurological diseases (such as epilepsy, stroke, brain injury, tumors, multiple sclerosis, Parkinson's, Alzheimer's, Huntington's, cerebral aneurysms, infections, hydrocephalus, or other neurodegenerative diseases)
- Metal implants or electronic devices in brain, head, or neck
- Participation in other clinical trials
- History of stroke, brain surgery, tumors, or head trauma
- Active scalp skin lesions, wounds, infections, or significant damage
- Diagnosis of schizophrenia or bipolar disorder
- History of suicidal behavior or significant self-harm
- Unstable treatment plans or recent medication changes
- Planning new treatments during the study
- Unable to consent
- Participation in neurotechnology or drug trials within 6 months
- Recent or planned surgical intervention for endometriosis within the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Alethios, Inc.
San Francisco, California, United States, 94109
Actively Recruiting
Research Team
N
Nirav Shah, MD, MPH
CONTACT
Z
Zeenia Framroze, BA MPhil
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here