An interventional study of NettleEndo and Sham NettleEndo Device in Endometriosis, sponsored by Samphire Group, Inc.. Recruiting at 1 site in United States. Open to female participants aged 22 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Samphire Group, Inc. · Not applicable, Interventional, and Treatment
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:
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:
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.
This is a decentralized, randomized, double-blind, sham-controlled clinical trial evaluating the efficacy, safety, and usability of the NettleEndo device for managing endometriosis-associated symptoms. The device delivers transcranial direct current stimulation (tDCS) and is used at home for 20 minutes per session, five sessions per week, over 12 weeks. The stimulation targets the left dorsolateral prefrontal cortex (DLPFC) and primary motor cortex (M1), both of which are involved in the modulation of pain and emotional regulation.
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.
920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.
This study's planned enrollment of 120 is above the median of 67 across 540 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Samphire Group, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For menstruating participants, all of the following need to be met:
For non-menstruating patients, all required:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: NettleEndo
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.
Device: Sham NettleEndo Device
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.
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.
Change in daily endometriosis-associated pain intensity (NRS)
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.
Time frame: Daily, throughout the study (6 months)
Change in endometriosis-specific quality of life (EHP-30)
Change from baseline in total and subscale scores on the Endometriosis Health Profile-30 (EHP-30), a 30-item scale assessing the quality of life specific to endometriosis. Each item is rated on a 5-point Likert scale (1 = "Not at all," 5 = "Extremely"). The scale includes subscales for Pain, Work, Social Relationships, Health, Sexual Activity, and Emotion, each with its own set of items. The total score ranges from 0 to 120, where 0 = No impact on quality of life and 120 = Maximum impact on quality of life. A higher score indicates worse quality of life.
Time frame: Monthly starting at baseline until the end of the study (6 months)
Change in general health status (EQ-5D-5L)
Change from baseline in EQ-5D-5L index scores, a 5-item scale assessing general health status. Each item is rated on a 5-point Likert scale (1 = No problems, 5 = Unable to do). The total index score is calculated based on responses across all five domains, with the score ranging from 0 (representing worst possible health) to 1 (representing best possible health). A higher score indicates better health status.
Time frame: Monthly starting at baseline until the end of the study (6 months)
Change in severity of illness and improvement over time (CGI)
The Clinical Global Impressions (CGI) scale is a brief, 3-item rating tool used by clinicians to assess the severity of a patient's illness, their improvement over time, and the efficacy of their treatment.
Time frame: Monthly starting at baseline until the end of the study (6 months)
Device adherence (number of sessions completed)
Total number of NettleEndo sessions completed over the 12-week intervention period, recorded by the device and app logs.
Time frame: Week 1 to Week 12
Exploratory - Change in pain catastrophizing (PCS)
Change from baseline in total score on the Pain Catastrophizing Scale (PCS), which consists of 13 items, each scored on a 5-point Likert scale (0 = Not at all, 4 = Extremely). The total score ranges from 0 to 52, with higher scores indicating more severe pain catastrophizing.
Time frame: Monthly starting at baseline until the end of the study (6 months)
Exploratory - Change in insomnia severity (ISI)
Change from baseline in total score on the Insomnia Severity Index (ISI), a 7-item self-report measure where each item is rated on a 0 to 4 scale. The total score is the sum of these ratings, with scores ranging from 0 to 28, where 0 = No insomnia and 28 = Severe insomnia. A higher score indicates worse insomnia severity.
Time frame: Monthly starting at baseline until the end of the study (6 months)
Daily medication use (analgesic and hormonal)
Daily use of pain medications and hormonal treatments recorded by participants via mobile app.
Time frame: Daily, throughout the study (6 months)
Exploratory - Change in depressive symptoms (PHQ-8)
Change from baseline in total score on the 8-item Patient Health Questionnaire (PHQ-8), a screening tool for depression that uses a 4-point Likert scale for each of its eight items. The total score ranges from 0 to 24, with 0 = No depressive symptoms and 24 = Severe depressive symptoms. A higher score indicates more severe depressive symptoms.
Time frame: Monthly starting at baseline until the end of the study (6 months)
Exploratory - Change in cyclical mood and physical symptoms (DRSP)
Change in symptoms assessed using the Daily Record of Severity of Problems (DRSP), a validated tool for tracking mood, behavioural, and physical symptoms across the menstrual cycle. Participants rate symptoms daily via mobile app on a 1-6 scale, where 1 = No symptoms and 6 = Severe symptoms. A decrease in DRSP scores indicates a better outcome, reflecting reduced mood and physical symptoms.
Time frame: Daily, throughout the study (6 months)
Incidence of device-related adverse events
Number and severity of adverse events (AEs) and serious adverse events (SAEs) deemed related to the NettleEndo device.
Time frame: Week 1 to Day 90 follow-up
Menstrual cycle characteristics and timing
Participants complete daily menstruation tracking using a mobile app, recording onset and duration of bleeding.
Time frame: Daily, throughout the study (6 months)
Exploratory analysis of Heart Rate Variability (HRV)
Heart rate variability (HRV) data will be collected from participants who opt in to wearable integration. HRV will be used in exploratory analyses to assess physiological patterns during the intervention and follow-up phases.
Time frame: Daily, throughout the study (6 months)
Exploratory analysis of step count
Step count data will be collected from participants who opt in to wearable integration. Step count will be used in exploratory analyses to assess behavioural patterns during the intervention and follow-up phases.
Time frame: Daily, throughout the study (6 months)
Exploratory analysis of sleep metrics
Sleep metrics will be collected from participants who opt in to wearable integration. These data will be used in exploratory analyses to assess physiological patterns during the intervention and follow-up phases.
Time frame: Daily, throughout the study (6 months)
Plan to share: No
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Samphire Group, Inc.