NCT06974773 · Samphire Group, Inc.
Remote Electrical Stimulation as a Long-term Intervention for Endometriosis Flare Ups
(RELIEF)
What this study 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.
View original scientific description
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.
Interventions
DEVICE
NettleEndo
The NettleEndo device is a portable, home-use transcranial direct current stimulation (tDCS) system designed to deliver low-intensity electrical stimulation to targeted brain regions. The device delivers a constant current of 2 mA in the active stimulation group, targeting the left primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC) through pre-set electrode positioning.
DEVICE
Sham NettleEndo Device
The sham version of the NettleEndo device is visually identical to the active device and is used under the same schedule. The device is pre-programmed to deliver a brief 2 mA current for 20 seconds at the beginning of each session to mimic the initial skin sensations of active stimulation, after which no current is delivered for the remainder of the session. This allows participants to remain blinded to their group assignment. The device is used with the same electrode positioning as the active version.
Primary outcome measures
Change in daily endometriosis-associated pain intensity (NRS)
Time frame: Daily, throughout the study (6 months)
Average change from baseline in daily self-reported pain intensity related to endometriosis, using a 0-10 Numerical Rating Scale (NRS). This will be measured separately for dysmenorrhea (Dysmenorrhea NRS; DYS NRS) and non-menstrual pelvic pain (Non-Menstrual Pelvic Pain; NMPP NRS). Collected via mobile app. A decrease in NRS, NMPP NRS and DYS NRS scores indicate a better outcome, as it reflects reduced pain intensity.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- San Francisco, California
Collaborators
Alethios, Inc.
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 18, 2025 · Source of record for eligibility and locations