[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05600738":3,"trial-entities:NCT05600738":96,"trial-summary:NCT05600738":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":18,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":45,"sex":51,"minimum_age":52,"maximum_age":14,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":65,"locations":68,"central_contacts":88,"overall_officials":91,"references":94,"see_also_links":95},"NCT05600738","HSC-MS-22-0045","Network Effects of Therapeutic Deep Brain Stimulation","RECRUITING","2027-12-31","2022-10","2022-10-31","2022-08-26","The University of Texas Health Science Center, Houston","OTHER",null,"The purpose of this study is to map the acute, short-term cortical evoked responses to thalamic electrical stimulation in persons with intractable epilepsy",[17],"Intractable Epilepsy",[19,20,21],"Deep brain stimulation (DBS)","neuromodulation therapy","Responsive Neurostimulation (RNS)","INTERVENTIONAL","BASIC_SCIENCE",[25],"NA",{"count":27,"type":28},25,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","RNS\u002FDBS activation","This will be performed to study the EEG responses to DBS\u002FRNS stimulation electrical pulses. The stimulation frequencies will be sequentially increased and each stimulation will last for 2 minutes.There will be a 1-2 minute wash out period after each trial.",[35],"Treatment",[37,40,42,44],{"measure":38,"timeFrame":39},"Change in amplitude of evoked potentials metrics as assessed by the scalp EEG","Baseline, Intra intervention (about 20 minutes after baseline)",{"measure":38,"timeFrame":41},"Baseline, post intervention (about 2 hours after baseline )",{"measure":43,"timeFrame":39},"Change in latencies of evoked potentials and phase synchronization metrics recorded as assessed by the scalp EEG",{"measure":43,"timeFrame":41},[46,49],{"measure":47,"description":48,"timeFrame":39},"Change in reaction time to visual stimuli measured as vigilance score assessed by the Psychomotor Vigilance test (PVT)","This is a computerized testing that will record errors in being unable to tap a switch\u002Fbutton",{"measure":47,"description":48,"timeFrame":50},"Baseline, post intervention (about 2 hours after baseline)","ALL","18 Years",false,{"inclusion":55,"exclusion":59,"raw_text":64},[56,57,58],"diagnosis of Epilepsy","undergoing neuromodulation therapy with clinically implanted neuromodulation devices (DBS, RNS)","followed in the outpatient epilepsy clinic",[60,61,62,63],"pregnant women","active psychosis, major depression, or suicidal ideation in the preceding year","Intelligence quotient (IQ) less than 70 as measured by clinical neuropsychological evaluation","Do not agree to share their medical records for research purposes","Inclusion Criteria:\n\n* diagnosis of Epilepsy\n* undergoing neuromodulation therapy with clinically implanted neuromodulation devices (DBS, RNS)\n* followed in the outpatient epilepsy clinic\n\nExclusion Criteria:\n\n* pregnant women\n* active psychosis, major depression, or suicidal ideation in the preceding year\n* Intelligence quotient (IQ) less than 70 as measured by clinical neuropsychological evaluation\n* Do not agree to share their medical records for research purposes",[66,67],"ADULT","OLDER_ADULT",[69],{"facility":70,"status":7,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":85},"The University of Texas Health Science Center at Houston","Houston","Texas","77030","United States",[76,81],{"name":77,"role":78,"phone":79,"email":80},"Sandipan Pati, MD","CONTACT","713-500-7925","Sandipan.Pati@uth.tmc.edu",{"name":82,"role":78,"phone":83,"email":84},"Jaison Hampson","713-500-7754","Jaison.S.Hampson@uth.tmc.edu",{"lat":86,"lon":87},29.76328,-95.36327,[89,90],{"name":77,"role":78,"phone":79,"email":80},{"name":82,"role":78,"phone":83,"email":84},[92],{"name":77,"affiliation":12,"role":93},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":97,"biomarkers":99},[98],"Seizure Disorder",[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an interventional study involving 25 participants. It is not specified if it is randomized or blinded.","completed","Network Effects of Therapeutic Deep Brain Stimulation for Intractable Epilepsy","This study is looking at how Deep Brain Stimulation (DBS) or Responsive Neurostimulation (RNS) affects the brain in people with epilepsy that hasn't responded to other treatments (intractable epilepsy). Researchers will activate your implanted DBS or RNS device and study your brain's electrical responses using an electroencephalogram (EEG), which measures brain waves. They want to see how the strength and timing of these brain responses change during and shortly after stimulation. You might be able to join if you have epilepsy, already have a DBS or RNS device, and are seen at an outpatient epilepsy clinic. The study aims to enroll 25 participants, but its current recruitment status is unclear.","The primary endpoints are measured at baseline, during the intervention (about 20 minutes after baseline), and post-intervention (about 2 hours after baseline).",110,"You would undergo RNS\u002FDBS activation, with stimulation frequencies sequentially increased. Each stimulation lasts 2 minutes, with a 1-2 minute washout period after each trial.","Not stated in the trial record.",[],"v2"]