[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587739":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":43,"locations":52,"responsibleParty":71,"collaborators":36,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":36,"eligibilityCriteria":79,"healthyVolunteers":76,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":36,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":54,"whyStopped":36,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Michigan","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Nerve Stimulation only","EXPERIMENTAL","Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will only perform dorsal genital nerve stimulation.",[13],"Device: Electrical Stimulation",{"label":15,"type":10,"description":16,"interventionNames":17},"Nerve Stimulation and Vibration","Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will perform dorsal genital nerve stimulation and use a smart vibrator.",[13,18],"Device: Smart vibrator",{"label":20,"type":21,"description":22,"interventionNames":23},"Vibration only","ACTIVE_COMPARATOR","Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will only use a smart vibrator.",[18],[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Electrical Stimulation","Electrical stimulation of the dorsal genital nerve will be accomplished using the UCon system and patch electrodes developed by InnoCon. The UCon system includes a programmable control unit; leads that connect to the control unit and electrodes; a silicone surface electrode; a reference electrode; and a remote control for quick on and off toggling of stimulation.",[15,9],[31],"UCon patch system",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Smart vibrator","Subjects will use a smart vibrator at home twice a week during the study. The Lioness smart vibrator records physiological responses during use.",[15,20],null,[38,41],{"name":39,"affiliation":5,"role":40},"Tim Bruns, PhD","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":5,"role":40},"Priyanka Gupta, MD",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":36,"email":48},"Yike Liu","CONTACT","734-647-8568","yikel@umich.edu",{"name":39,"role":46,"phone":50,"phoneExt":36,"email":51},"734-647-8727","bruns@umich.edu",[53],{"facility":5,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-83.74088,42.27756,{"lat":64,"lon":63},[67,68,69],{"name":45,"role":46,"phone":47,"phoneExt":36,"email":48},{"name":39,"role":40,"phone":36,"phoneExt":36,"email":36},{"name":42,"role":70,"phone":36,"phoneExt":36,"email":36},"SUB_INVESTIGATOR",{"type":40,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Timothy Bruns","Associate Professor of Biomedical Engineering","100587739","at-home-neuromodulation-for-female-sexual-dysfunction-100587739",false,"NCT06932302","At-Home Neuromodulation for Female Sexual Dysfunction","Inclusion Criteria:\n\n* Capable of speaking and understanding English.\n* Able to comprehend the clinical study procedures and provide informed consent.\n* Identified as having female sexual dysfunction with a Female Sexual Function Index (FSFI) score of 26.55 or less and a score of 3 or less on one or more of the FSFI subdomains of lubrication, arousal, and orgasm.\n* Willing and able to adhere to the study protocol\n* Able to attend experimental sessions at Michigan Medicine at both the start and conclusion of the study.\n\nExclusion Criteria:\n\n* Not currently sexually active.\n* Pregnant or planning to get pregnant during the study period.\n* History of a neurological disorder or impairments affecting pelvic organ function, including diagnosed with dorsal genital nerve damage, lower motor dysfunction, or other related conditions.\n* Implanted with a neurostimulator for bladder or bowel function.\n* Have a skin condition that would predispose them to sensitivity to the stimulation electrodes.\n* Female sexual dysfunction limited solely to low desire, without issues in lubrication, arousal, or orgasm.\n* Clinically diagnosed bladder dysfunction, pelvic pain, or other pelvic organ symptoms; or a score of 8 or higher on the American Urological Association Symptom Index (AUASI).\n* Unable or unwilling to adhere to the study protocol\n* Simultaneously participating in another research study that may affect the results of this study.","FEMALE","18 Years","85 Years",{"count":84,"type":85},24,"ESTIMATED","INTERVENTIONAL",[88],"NA","This pilot study investigates the regular use of non-invasive dorsal genital nerve stimulation (DGS) for the treatment of female sexual dysfunction (FSD). The researchers aim to determine whether subjects with FSD can correctly follow an at-home treatment regimen and to demonstrate that DGS can improve FSD arousal symptoms in premenopausal and postmenopausal women. Some subjects will use a smart vibrator for comparison to DGS.",[91],"Female Sexual Dysfunction",[93,94],"dorsal genital nerve stimulation","neuromodulation","2025-12-16",{"date":97,"type":98},"2025-12-23","ACTUAL",{"date":100,"type":98},"2025-10-15",{"date":102,"type":85},"2027-11",{"name":5,"class":6},1]