[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591003":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":63,"collaborators":65,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Samphire Group, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active tDCS - NettleEndo Device","EXPERIMENTAL","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.",[13],"Device: NettleEndo",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham tDCS - NettleEndo Device","SHAM_COMPARATOR","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.",[19],"Device: Sham NettleEndo Device",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[15],[32],{"name":33,"affiliation":26,"role":34},"Nirav Shah, MD, MPH","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+1 650-206-8006","nirav@investigator.alethios.com",{"name":41,"role":37,"phone":26,"phoneExt":26,"email":42},"Zeenia Framroze, BA MPhil","support@alethios.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Alethios, Inc.","RECRUITING","San Francisco","California","94109","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-122.41942,37.77493,{"lat":56,"lon":55},[59,60,62],{"name":41,"role":37,"phone":38,"phoneExt":26,"email":42},{"name":33,"role":37,"phone":38,"phoneExt":26,"email":61},"zeenia@alethios.com",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":64,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[66],{"name":45,"class":6},"100591003","remote-electrical-stimulation-as-a-long-term-intervention-for-endometriosis-flare-ups-100591003",false,"NCT06974773","Remote Electrical Stimulation as a Long-term Intervention for Endometriosis Flare Ups","At-Home Transcranial Direct Current Stimulation (tDCS) Using the NettleEndo Device for Reducing Symptoms of Endometriosis - A Pivotal Double-Blind, Randomized, Placebo-Controlled Clinical Trial","RELIEF","Inclusion Criteria\n\n* Female, 22-45 years old\n* Assigned female at birth\n* Fluent in English\n* Capacity to consent\n* Confirmed diagnosis of endometriosis by a qualified physician, via:\n* Laparoscopic surgery with biopsy-proven endometriosis, OR\n* Clear evidence of ovarian endometrioma or deep infiltrating endometriosis on ultrasound\u002FMRI\n* Pain levels:\n\nFor menstruating participants, all of the following need to be met:\n\n* Regular menstrual cycles (21-35 days)\n* Mean DYS NRS ≥4 during menstrual bleeding days (over the last 28 days, self-assessed)\n* AND Mean NMPP NRS ≥4 during non-menstrual days (over the last 28 days, self-assessed)\n\nFor non-menstruating patients, all required:\n\n* Irregular\u002Fabsent cycles OR post-hysterectomy OR surgically menopausal\n* Mean pelvic pain NRS ≥4 (over the last 28 days, self-assessed)\n* Pain present on ≥50% of days\n* Access to a smartphone with an internet data plan, phone must be iOS 13.4+, or Android 12+.\n* No hormonal contraception or at least 6 months of consistent adherence to any hormonal contraception (e.g., IUD, pill, injection).\n* Capacity to follow instructions and operate the study device.\n\nExclusion Criteria\n\n* Pregnancy\u002Fbreastfeeding or planning to become pregnant in next 6 months\n* History of epileptic neurological conditions in the immediate family\n* Severe\u002Funtreated 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)\n* Metal implants\u002Felectronic devices in brain, head, or neck area\n* Participating in any other clinical trial\n* History of stroke, brain surgery, tumors, head trauma\n* Active skin lesions, open wounds, cuts, or infections on the scalp\n* Active scalp conditions (dermatitis, eczema, psoriasis)\n* Significant scarring\u002Fburns\u002Fother skin damage on scalp\n* Schizophrenia or bipolar disorder\n* 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.\n* Treatment plan must be stabilized (≥6 weeks analgesic\u002F ≥6 months hormonal contraception, and crucially no new medication changes before randomization)\n* Planning to commence any new treatment during intervention period\n* Lack of capacity to consent\n* Participation in a neurotechnology or drug trial in the last 6 months.\n* Recent surgical intervention for endometriosis within 6 months of enrollment or planned surgical intervention for endometriosis during the study period.","FEMALE","22 Years","45 Years",{"count":79,"type":80},120,"ESTIMATED","INTERVENTIONAL",[83],"NA","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.\n\nThe main questions it aims to answer are:\n\n1. Does at-home transcranial direct current stimulation (tDCS) reduce daily pain intensity in women with endometriosis?\n2. Does the device also improve mood and sleep quality?\n\nResearchers 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.\n\nParticipants will:\n\n1. Use the NettleEndo device at home for 20 minutes per session, five times per week for 12 weeks\n2. Be randomly assigned to receive either real or sham stimulation through the device\n3. Complete daily and weekly symptom ratings through a mobile app\n4. Be followed for 90 days after completing the intervention to monitor longer-term effects\n\nAll 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.",[86],"Endometriosis",[86,88,89,90,91,92],"Dysmenorrhea","Chronic Pelvic Pain","tDCS","Neuromodulation","Women's Health","2025-12-10",{"date":95,"type":96},"2025-12-18","ACTUAL",{"date":98,"type":96},"2025-12-04",{"date":100,"type":80},"2026-08-01",{"name":5,"class":6},1]