[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07725601":3,"trial-entities:NCT07725601":83,"trial-summary:NCT07725601":86},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":47,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":58,"locations":61,"central_contacts":77,"overall_officials":80,"references":81,"see_also_links":82},"NCT07725601","2094518","VNS Algorithm for Advanced Dosing","VNS Algorithm for Advanced Dosing: Example Guided Mode Titrations \"The Augusta Way\"","RECRUITING","2030-12-30","2026-07","2026-07-24","2025-08-01","Fernando Vale","OTHER",false,"The goal of this clinical trial is to compare the standard programming of the VNS device (Control) to a modified programming (Augusta Way) in adults with epilepsy. The main question it aims to answer is:\n\nDoes the modified programming of the VNS reduce seizures faster than the standard programming?\n\nParticipants in both groups will:\n\n1. Attend up to 3 study visits every 3 months for 2 years\n2. Answer questionnaires to assess quality of life and cognitive function\n3. Maintain a diary of seizure activity","Little has changed in the last 10 years or more in regard to Vagus nerve stimulator (VNS) therapy programming parameters despite new technological advances. The goal of our study is to provide a comprehensive VNS dosing protocol which VNS programmers can refer to as the standard care of treatment escalation in patients with drug refectory epilepsy. Given the lack of newly published data regarding VNS system parameters, this study will allow epileptologists, general neurologists and neurosurgeons alike, access to an updated reference and model of VNS parameter escalation and treatment.\n\nThe investigators at Augusta University have developed a programming paradigm that appears to provide good clinical outcomes for VNS patients. The study will provide a comprehensive assessment of an experimental group (\"the Augusta Way\") programmed with a modified, more rapid titration paradigm developed at our site vs. \"best clinical practice\" (standard titration paradigm) control group of patients with VNS devices. The patients will be followed for at least 24 months post implantation. The study will assess safety of the new programming paradigm and will assess efficacy based upon seizure outcomes.",[19],"Epilepsies",[21,22],"Vagal Nerve Stimulation","Drug-Resistant Epilepsy","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},80,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","Rapid Titration VNS programming","Modified programming of VNS that provides rapid titration",[36],"Augusta Way",{"type":32,"name":38,"description":39,"armGroupLabels":40},"Standard VNS programming","Standard of Care VNS programming",[41],"Control",[43],{"measure":44,"description":45,"timeFrame":46},"Seizure Diary","A seizure diary is a personalized log used to record seizure activity, medication adherence, and potential triggers","From enrollment to end of participation at 2 years",[],"ALL","18 Years","75 Years",{"inclusion":52,"exclusion":55,"raw_text":57},[53,54],"Subjects who are clinically determined to be candidates for VNS implantation for seizure control","Subject\u002Flegally authorized representative able to provide informed consent.",[56],"Subjects with VNS system treating pathologies other than drug refractory epilepsy or medical co-morbidities that prevent any surgical intervention","Inclusion Criteria:\n\n* Subjects who are clinically determined to be candidates for VNS implantation for seizure control\n* Subject\u002Flegally authorized representative able to provide informed consent.\n\nExclusion Criteria:\n\n* Subjects with VNS system treating pathologies other than drug refractory epilepsy or medical co-morbidities that prevent any surgical intervention",[59,60],"ADULT","OLDER_ADULT",[62],{"facility":63,"status":8,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":74},"Wellstar MCG Hospital","Augusta","Georgia","30912","United States",[69],{"name":70,"role":71,"phone":72,"email":73},"Brandy Quarles, MPH","CONTACT","7067210390","bquarles@augusta.edu",{"lat":75,"lon":76},33.47097,-81.97484,[78],{"name":70,"role":71,"phone":79,"email":73},"706-721-0390",[],[],[],{"nct_id":4,"conditions":84,"biomarkers":85},[22],[],{"nct_id":4,"found":87,"summary":88,"prompt_version":98},true,{"design":89,"status":90,"heading":91,"summary":92,"follow_up":93,"word_count":94,"commitments":95,"compensation":96,"drugs_mentioned":97},"This study will compare two different VNS programming methods in 80 participants. It is an interventional study, meaning participants will receive one of the two programming methods.","completed","VNS Algorithm for Advanced Dosing in Epilepsy","This study is looking at adults with epilepsy who are candidates for a Vagus Nerve Stimulator (VNS) implant. The VNS is a device that helps control seizures. The study compares two ways of programming the VNS device: \"Standard VNS programming\" (the usual way) and \"Rapid Titration VNS programming\" (a modified, faster approach). The main goal is to see if the Rapid Titration VNS programming can reduce seizures more quickly than the standard method. You could join if you are between 18 and 75 years old and are planning to get a VNS implant for epilepsy. The study plans to enroll 80 people.","Participants will be followed for seizure activity from enrollment until the end of participation at 2 years.",102,"You would attend up to 3 study visits every 3 months for 2 years. You would also answer questionnaires about your quality of life and thinking, and keep a diary of your seizure activity.","Not stated in the trial record.",[33,38],"v2"]