Remote Electrical Stimulation as a Long-term Intervention for Endometriosis Flare Ups
NCT ID: NCT06974773
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-12-04
2026-08-01
Brief Summary
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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.
Detailed Description
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Participants are randomly assigned in a 1:1 ratio to receive either active or sham stimulation. The sham group receives a brief stimulation ramp-up (2 mA for 20 seconds) to mimic sensation but no sustained current. All participants use the same wearable device, complete self-report measures through a mobile app, and are blinded to group assignment.
Data are collected using the Alethios platform, a compliant digital health system that supports electronic informed consent, daily and monthly questionnaires, adverse event tracking, and automated session logging. Optional wearable integration allows for passive data capture, including sleep, activity, and heart rate variability.
The trial includes a 12-week treatment period followed by a 90-day follow-up phase. Outcomes include pain intensity, mood, sleep, and quality of life. Randomization is stratified by pain level and menstrual cycle status. Interim analyses are planned after approximately one-third and two-thirds of participants complete the intervention.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active tDCS - NettleEndo Device
Participants assigned to this arm will receive active transcranial direct current stimulation (tDCS) using the NettleEndo wearable device. The device delivers 2 mA of stimulation for 20 minutes per session, five sessions per week, for a total of 12 weeks. Stimulation is delivered over the left primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC) using pre-programmed settings. Participants complete all sessions at home and log outcomes via a mobile app. Device use is monitored remotely through digital logs.
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.
Sham tDCS - NettleEndo Device
Participants assigned to this arm will receive sham transcranial direct current stimulation (tDCS) using the NettleEndo wearable device. The device mimics the sensation of active stimulation by ramping up to 2 mA for 20 seconds before turning off, with no therapeutic current delivered for the remainder of the 20-minute session. Participants use the device five times per week for 12 weeks. Sessions are completed at home, and outcome measures are recorded via a mobile app. Device use is remotely monitored via app-based logging. Participants and investigators are blinded to group allocation.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
22 Years
45 Years
FEMALE
No
Sponsors
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Alethios, Inc.
UNKNOWN
Samphire Group, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nirav Shah, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Locations
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Alethios, Inc.
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Zeenia Framroze, BA MPhil
Role: primary
Nirav Shah, MD, MPH
Role: backup
Other Identifiers
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RELIEF25
Identifier Type: -
Identifier Source: org_study_id