[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100414525":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":27,"studyPopulation":27,"armGroups":43,"interventions":49,"overallOfficials":55,"centralContacts":59,"locations":67,"responsibleParty":85,"collaborators":27,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":27,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":27,"studyType":101,"phases":102,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":70,"whyStopped":27,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":27},[9,13],{"measure":10,"description":11,"timeFrame":12},"Percent change in number of disabling clinical seizures","This will be measured by self reporting journals","Baseline,12 weeks post treatment",{"measure":14,"description":11,"timeFrame":12},"Changes in seizure severity",[16,19,22,25,29,31,33,35],{"measure":17,"description":18,"timeFrame":12},"Change in cognition and mood as assessed by the Quality Of Life In Epilepsy (QOLIE-10) questionnaire","This is a 10 item questionnaire. Score ranges from 1-6,a higher number indicating a worse outcome.",{"measure":20,"description":21,"timeFrame":12},"Change in cognition and mood as assessed by the Patient Health Questionnaire (PHQ-9)","PHQ-9 score can range from 0 to 27,each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day).",{"measure":23,"description":24,"timeFrame":12},"Change in cognition and mood as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) scale","This is a 7 item questionnaire. Each question is scored form 0(not at alll) to 3(nearly every day)",{"measure":26,"description":27,"timeFrame":28},"Average number of detections of seizures per-day (as stored by the RNS System)",null,"Baseline",{"measure":26,"description":27,"timeFrame":30},"end of 1 month",{"measure":26,"description":27,"timeFrame":32},"end of 2 months",{"measure":26,"description":27,"timeFrame":34},"end of 3 months",{"measure":26,"description":27,"timeFrame":36},"1 month after last treatment",{"allocation":38,"interventionModel":39,"interventionModelDescription":27,"primaryPurpose":40,"observationalModel":27,"timePerspective":27,"maskingInfo":41},"NA","SINGLE_GROUP","SUPPORTIVE_CARE",{"masking":42,"maskingDescription":27,"whoMasked":27},"NONE",[44],{"label":45,"type":46,"description":27,"interventionNames":47},"Experimental group","EXPERIMENTAL",[48],"Device: Acupuncture intervention",[50],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":27},"DEVICE","Acupuncture intervention","Participants will undergo 12 weeks of acupuncture therapy. There will be one 40 minute-1 hour. session per week.",[45],[56],{"name":57,"affiliation":5,"role":58},"Olga Rodziyevska, MS,PA-C","PRINCIPAL_INVESTIGATOR",[60,64],{"name":57,"role":61,"phone":62,"phoneExt":27,"email":63},"CONTACT","(713) 500-5482","Olga.Rodziyevska@uth.tmc.edu",{"name":65,"role":61,"phone":62,"phoneExt":27,"email":66},"Ardonia N Tousant","Ardonia.N.Tousant@uth.tmc.edu",[68],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"The University of Texas Health Science Center at Houston","RECRUITING","Houston","Texas","77030","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-95.36327,29.76328,{"lat":80,"lon":79},[83,84],{"name":57,"role":61,"phone":62,"phoneExt":27,"email":63},{"name":65,"role":61,"phone":62,"phoneExt":27,"email":66},{"type":58,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Olga Rodziyevska","Physician Assistant","100414525","clinical-and-electrographic-changes-in-responsive-neurostimulation-system-rns-patients-with-acupuncture-treatment-100414525",false,"NCT04677751","Clinical and Electrographic Changes in Responsive Neurostimulation System (RNS) Patients With Acupuncture Treatment","Clinical and Electrographic Changes in RNS System Patients With Acupuncture Treatment","Inclusion Criteria:\n\n* Patient implanted with the RNS system\n* Patient can undergo 12 weeks of acupuncture\n* Patient is able remain on stable medications for 12 weeks\n* Patient is able to remain on stable Detection and Stimulation settings for 12 weeks\n* Patient or\u002Fand caregiver is able to understand and sign informed consent and HIPAA authorization\n* Patient or caregiver able to maintain a seizure diary for duration of study\n\nExclusion Criteria:\n\n* Patient and \u002For caregiver is unable to sign informed consent to study\n* Patient has a bleeding disorder, pacemaker, or pregnant","ALL","15 Years","60 Years",{"count":99,"type":100},10,"ESTIMATED","INTERVENTIONAL",[38],"The purpose of this study is to determine effects of Acupuncture on a Patient's mood and cognition,evaluate changes in clinically-reported seizure frequency and severity and analyze effects of Acupuncture on electrographic epileptiform activity stored by the RNS System",[105],"Epilepsy",[107,108,109],"acupuncture","RNS","seizure","2026-10-07",{"date":112,"type":113},"2026-10-13","ACTUAL",{"date":115,"type":113},"2021-04-01",{"date":117,"type":100},"2027-12-30",{"name":5,"class":6},1]