[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Samphire Group, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":92},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100645235","crest-samphire-guided-care-program-on-wellbeing-work-productivity-and-quality-of-life-100645235",false,"NCT07679074","CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life","A 12-Week Prospective Cohort Study Evaluating the Efficacy of the Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life in Individuals With Menstrual and Pelvic Health Conditions","CREST","Inclusion Criteria:\n\n* Self-identified female, aged 18-65 years at the time of enrollment\n* Basic English literacy\n* Able and willing to provide informed consent electronically\n* Residing in the United States\n* Reporting mood or cognitive symptoms associated with menstruation, perimenopause, or menopause (must endorse a minimum of three of the following: irritability, emotional dysregulation, brain fog, fatigue, reduced concentration, sleep disruption, or low mood)\n* Symptoms present for at least 3 months and sufficiently severe to interfere with daily functioning, work performance, quality of life, or interpersonal relationships\n* Currently in full-time employment with medical benefits as part of compensation package\n* Access to a smartphone with internet access compatible with the Samphire mobile application\n* Able to safely operate the study device in the home environment\n* Willing to complete baseline, mid-program, and end-of-program questionnaires and engage with the 12-week guided care program\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding, or actively planning pregnancy during the study period\n* History of epilepsy or seizure disorder\n* Severe or unstable neurological disease that, in the opinion of the study team, may increase risk or interfere with participation\n* Implanted electronic or metal devices in the head, neck, or brain region contraindicated for tDCS use\n* Active scalp lesions, open wounds, or dermatologic conditions at electrode sites that may interfere with safe device use\n* Current diagnosis of schizophrenia, bipolar disorder, or other severe psychiatric condition that would make participation inappropriate, as determined by screening\n* Active suicidal ideation, recent suicidal behavior, or clinically significant self-injurious behavior, as determined by participant self-report during screening\n* Inability to provide informed consent or safely use the device in the home environment\n* Current participation in another interventional neurotechnology or drug study",true,"FEMALE","18 Years","65 Years",{"count":22,"type":23},50,"ESTIMATED","OBSERVATIONAL","This study evaluates the feasibility and efficacy of the Samphire Guided Care (SGC) program\n\n* a 12-week structured digital health program combining clinician-led onboarding, at-home neuromodulation using the Lutea tDCS device, neuromodulation coach support, and app-based symptom tracking - on work productivity, employee wellbeing, and quality of life in individuals experiencing mood and cognitive symptoms associated with menstruation, perimenopause, or menopause.",[27,28,29,30,31,32,33],"Premenstrual Syndrome","Premenstrual Dysphoric Disorder","Dysmenorrhea","Endometriosis","Perimenopause","Menopause","Pelvic Pain",[35,36,37,38,39,40,41,42,43,44,45,46,47,48,49],"tDCS","neuromodulation","hormonal health","menstrual symptoms","perimenopause","menopause","PMDD","PMS","work productivity","brain fog","mood","cognitive function","digital health","decentralized clinical trial","guided care","RECRUITING","2026-06-25",{"date":53,"type":54},"2026-07-01","ACTUAL",{"date":56,"type":54},"2026-06-01",{"date":58,"type":23},"2027-03-01",{"name":60,"class":61},"Samphire Group, Inc.","INDUSTRY",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":18,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":62},"100591003","remote-electrical-stimulation-as-a-long-term-intervention-for-endometriosis-flare-ups-100591003","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.","22 Years","45 Years",{"count":74,"type":23},120,"INTERVENTIONAL",[77],"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.",[30],[30,29,81,35,82,83],"Chronic Pelvic Pain","Neuromodulation","Women's Health","2025-12-10",{"date":86,"type":54},"2025-12-18",{"date":88,"type":54},"2025-12-04",{"date":90,"type":23},"2026-08-01",{"name":60,"class":61},""]