[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645235":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":34,"centralContacts":38,"locations":46,"responsibleParty":64,"collaborators":10,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":10,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":91,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Samphire Group, Inc.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A - Neuromodulation Cohort",null,"Participants assessed as eligible for neuromodulation at the clinician onboarding consultation who accept the Lutea device and complete at least 30% of recommended tDCS sessions across the 12-week program. Group A participants receive the full SGC program including clinician consultation, Lutea device, neuromodulation coach support, and app-based symptom tracking.",[13,14],"Device: Lutea Transcranial Direct Current Stimulation (tDCS) Device","Behavioral: Samphire Guided Care Program",{"label":16,"type":10,"description":17,"interventionNames":18},"Group B - Comparison Cohort","Participants who either decline the Lutea device following the clinician consultation, or who accept the device but complete fewer than 30% of recommended sessions across the 12-week program. Group B participants receive the same SGC program components as Group A excluding substantive neuromodulation engagement.",[14],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Lutea Transcranial Direct Current Stimulation (tDCS) Device","The Lutea device (Samphire Group, Inc.) is an FCC-registered consumer wellness wearable that delivers low-intensity transcranial direct current stimulation (tDCS) targeting the primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC). Sessions are 20 minutes in duration at a recommended frequency of multiple sessions per week, self- administered at home. The device does not meet the FDA's statutory definition of a medical device; it is intended for general wellness purposes and is not cleared or approved for the diagnosis, cure, mitigation, treatment, or prevention of any disease.",[9],[26],"Lutea",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"BEHAVIORAL","Samphire Guided Care Program","A 12-week structured digital health program comprising: clinician-led neuromodulation eligibility assessment and care pathway assignment at onboarding; ongoing neuromodulation coach support; and app-based daily symptom tracking via the Alethios digital research platform. All participants in both groups receive this program component.",[9,16],[33],"SGC Program",[35],{"name":36,"affiliation":5,"role":37},"Nirav Shah, MD, MPH","PRINCIPAL_INVESTIGATOR",[39,43],{"name":36,"role":40,"phone":41,"phoneExt":10,"email":42},"CONTACT","6267201547","nirav@investigator.alethios.com",{"name":44,"role":40,"phone":10,"phoneExt":10,"email":45},"Zeenia Framroze","support@alethios.com",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Alethios Digital Research Platform (Decentralized)","RECRUITING","San Francisco","California","94105","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-122.41942,37.77493,{"lat":59,"lon":58},[62,63],{"name":44,"role":40,"phone":10,"phoneExt":10,"email":45},{"name":36,"role":37,"phone":10,"phoneExt":10,"email":10},{"type":65,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":79,"type":80},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.",[84,85,86,87,88,89,90],"Premenstrual Syndrome","Premenstrual Dysphoric Disorder","Dysmenorrhea","Endometriosis","Perimenopause","Menopause","Pelvic Pain",[92,93,94,95,96,97,98,99,100,101,102,103,104,105,106],"tDCS","neuromodulation","hormonal health","menstrual symptoms","perimenopause","menopause","PMDD","PMS","work productivity","brain fog","mood","cognitive function","digital health","decentralized clinical trial","guided care","2026-06-25",{"date":109,"type":110},"2026-07-01","ACTUAL",{"date":112,"type":110},"2026-06-01",{"date":114,"type":80},"2027-03-01",{"name":5,"class":6},1]