[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623537":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":61,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":26,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":26,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Seoul National University Bundang Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group: Conventional Speech Therapy + Digital Speech Therapy","EXPERIMENTAL","Performs conventional speech therapy for 30 minutes daily + additional digital speech therapy program during the 2-week treatment period.",[13,14],"Device: Zenicog","Other: Conventional Speech Therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group: Conventional Speech Therapy","ACTIVE_COMPARATOR","Performs only conventional speech therapy for 30 minutes daily during the 2-week treatment period.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Zenicog","This medical device is a Software as a Medical Device (SaMD) consisting of a patient application and a patient management web portal for medical staff. It is designed to provide personalized digital therapeutic content to patients with aphasia for the alleviation and improvement of language function symptoms.\n\nThe therapeutic mechanism of this device is speech therapy delivered through a personalized content program, intended to improve the language function of aphasia patients. The device's treatment program alleviates and improves language function based on Stimulation-Facilitation Treatment and Functional Communication techniques, which are aphasia speech therapy methods recommended by the Korean Clinical Practice Guidelines for Stroke Rehabilitation (Brain \\& Neurorehabilitation).\n\nThe training recommendation model applied to this device provides personalized training content based on the subject's performance characteristics and proficiency level. The analyzed performance character",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional Speech Therapy","Conventional speech therapy is provided for 30 minutes daily in face-to-face by a Speech-Language-Pathologist",[16,9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Pf. Won Kee Chang, MD, MS","CONTACT","+82-31-787-7737","wkchang@snubh.org",[38,48,56],{"facility":5,"status":39,"city":40,"state":26,"zip":26,"country":41,"countryCode":26,"cosmosGeoPoint":42,"geoPoint":47,"contacts":26},"RECRUITING","Seongnam-si","South Korea",{"type":43,"coordinates":44},"Point",[45,46],127.13778,37.43861,{"lat":46,"lon":45},{"facility":49,"status":39,"city":50,"state":26,"zip":26,"country":41,"countryCode":26,"cosmosGeoPoint":51,"geoPoint":55,"contacts":26},"Konkuk University Medical Center","Seoul",{"type":43,"coordinates":52},[53,54],126.9784,37.566,{"lat":54,"lon":53},{"facility":57,"status":39,"city":50,"state":26,"zip":26,"country":41,"countryCode":26,"cosmosGeoPoint":58,"geoPoint":60,"contacts":26},"Samsung Medical Center",{"type":43,"coordinates":59},[53,54],{"lat":54,"lon":53},{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Won Kee Chang","Assistant Professor",[66,68],{"name":67,"class":6},"Konkuk University Hospital",{"name":57,"class":6},"100623537","phase-2-exploratory-evaluation-of-the-digital-therapeutic-device-zenicom-for-subacute-stroke-aphasia-100623537",false,"NCT07397923","Exploratory Evaluation of the Digital Therapeutic Device Zenicom for Subacute Stroke Aphasia","Evaluation of the Safety and Efficacy of the Digital Therapeutic Device Zenicom for Improving Aphasia in Patients With Subacute Stroke and Aphasia (AQ ≥25), a Multicenter, Single-blind, Prospective, Randomized Exploratory Clinical Trial","Inclusion Criteria:\n\n* Aged 19 years or older.\n* Confirmed by a specialist to have aphasia caused by a stroke lesion.\n* First-ever subacute stroke (within 3 months of onset) diagnosed via radiological examination (CT, MRI).\n* Diagnosed with aphasia based on the Speech Assessment (PK-WAB-R).\n* Whose native language is Korean.\n\nExclusion Criteria:\n\n* Have progressive or hemodynamically unstable stroke.\n* Having other neurological diseases suspected to affect language ability.\n* Co-morbid major psychiatric disorders requiring continuous medication (e.g., Major Depressive Disorder, Schizophrenia, Bipolar Disorder, Dementia).\n* Co-morbid major neurogenic diseases other than stroke.\n* Confirmed history of degenerative neuropathy.\n* Current or past substance or alcohol use disorder.\n* Visual impairment (Low vision severity: visual acuity of 0.1-0.3 or lower).\n* Intellectual disability.\n* Illiteracy (unable to read and consent).","ALL","19 Years",{"count":79,"type":80},20,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","Clinical Trial Title A Multicenter, Single-Blind, Prospective, Randomized, Exploratory Clinical Trial to Evaluate the Safety and Efficacy of the Digital Therapeutic Device 'Zenicom' for Improving Aphasia in Patients with Subacute Stroke\n\nClinical Trial Objectives To evaluate the efficacy of the digital therapeutic device Zenicom.\n\nTo evaluate the safety of the digital therapeutic device Zenicom.\n\nClinical Trial Period 6 months from the date of clinical trial plan approval by the Ministry of Food and Drug Safety (MFDS).\n\nTarget Condition Patients with aphasia resulting from stroke lesions.\n\nTarget Sample Size Total of 20 subjects (10 in the experimental group and 10 in the control group).\n\nInvestigational Medical Device Zenicom\n\nClinical Trial Methodology\n\n1. Device Information\n\n   A) Experimental Device: Digital Speech Therapy Application\n\n   Group: Performs conventional speech therapy for 30 minutes daily + additional digital speech therapy program during the 2-week treatment period.\n\n   B) Control Device: Conventional Speech Therapy\n\n   Group: Performs only conventional speech therapy for 30 minutes daily during the 2-week treatment period.\n2. Treatment Duration:\n\n   Total 2 weeks (10 working days; total usage of 600 minutes or more).\n3. Visits:\n\nTotal of 3 visits including outpatient and therapy room visits.\n\nVisit 1 (T-1): Screening\n\nVisit 2 (T0): Baseline and Treatment initiation\n\nVisit 3 (T1): Post-treatment assessment\n\nInclusion and Exclusion Criteria\n\n1. Inclusion Criteria Patients who satisfy all of the following criteria:\n\n   Adults aged 19 years or older.\n\n   Patients confirmed by a specialist to have aphasia caused by a stroke lesion.\n\n   Patients with first-ever subacute stroke (within 3 months of onset) diagnosed via radiological examination (CT, MRI).\n\n   Patients diagnosed with aphasia based on the Speech Assessment (PK-WAB-R).\n\n   Patients whose native language is Korean.\n\n   Patients capable of voluntarily consenting to the study.\n2. Exclusion Criteria Patients meeting any of the following criteria will be excluded:\n\nProgressive or hemodynamically unstable stroke.\n\nPatients with other neurological diseases suspected to affect language ability.\n\nCo-morbid major psychiatric disorders requiring continuous medication (e.g., Major Depressive Disorder, Schizophrenia, Bipolar Disorder, Dementia).\n\nCo-morbid major neurogenic diseases other than stroke.\n\nConfirmed history of degenerative neuropathy.\n\nCurrent or past substance or alcohol use disorder.\n\nVisual impairment (Low vision severity: visual acuity of 0.1-0.3 or lower).\n\nIntellectual disability.\n\nIlliteracy (unable to read and consent).\n\nPatients deemed inappropriate for participation for other reasons.\n\nRefusal to participate in the study.\n\nSuspension and Dropout Criteria\n\n1. Suspension Criteria\n\n   If circumstances observed during the trial make it judged unreasonable to continue the study.\n\n   Occurrence of Serious Adverse Events (SAE).\n2. Dropout Criteria\n\nThe subject requests to stop participation or withdraws consent during the trial.\n\nThe investigator determines that the subject cannot continue the trial due to adverse events (e.g., headache, eye fatigue, nausea, dizziness, etc.).\n\nThe subject arbitrarily takes medication expected to affect the comparative evaluation of the investigational device during the trial.\n\nThe dosage of medication that may affect the comparative evaluation of the investigational device is changed during the trial.\n\nDiscovery of major protocol violations, such as violation of inclusion\u002Fexclusion criteria.\n\nThe subject fails to attend scheduled visits and cannot be contacted.\n\nThe subject fails to perform the digital speech therapy program for a total of 600 minutes or more.\n\nThe investigator determines that the trial should be stopped for other reasons.\n\nEndpoints (Outcome Measures)\n\n1. Primary Efficacy Endpoint\n\n   Change in PK-WAB-R scores between T0 and T1 between groups.\n2. Secondary Efficacy Endpoints\n\nChange in K-BNT scores between T0 and T1 between groups.\n\nChange in K-SAQOL-12 scores between T0 and T1 between groups.\n\nStatistical Analysis Methods To evaluate the change in PK-WAB-R between T0 and T1 between groups, an independent two-sample test will be used. Depending on the distribution of the change, a parametric method (Student's t-test) or a non-parametric method (Mann-Whitney U test) will be selected and applied.\n\nTo evaluate the changes in K-BNT and K-SAQOL-12 between T0 and T1 between groups, an independent two-sample test will be used. Depending on the distribution of the change, a parametric method (Student's t-test) or a non-parametric method (Mann-Whitney U test) will be selected and applied.",[86,87],"Aphasia","Stroke",[89,90,91,92],"digital therapeutics","aphasia treatment","subacute stroke","korean language","2026-02-07",{"date":95,"type":96},"2026-02-10","ACTUAL",{"date":98,"type":96},"2025-12-10",{"date":100,"type":80},"2026-08-31",{"name":5,"class":6},3]