[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07663578":3,"trial-entities:NCT07663578":89,"trial-summary:NCT07663578":94},{"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":16,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":44,"healthy_volunteers":45,"eligibility_criteria":46,"std_ages":57,"locations":60,"central_contacts":78,"overall_officials":84,"references":87,"see_also_links":88},"NCT07663578","2226959","Cognitive and Electrophysiological Assessment of Non-Invasive Temporally-Interfering Electric Fields Stimulation (TIEFS)","RECRUITING","2027-04-15","2026-06","2026-06-23","2025-04-16","University of California, Davis","OTHER",false,"The goal of this clinical trial is to learn how a non-invasive brain stimulation method called Temporally Interfering Electric Fields Stimulation (TIEFS) affects brain activity and thinking in adults. TIEFS uses electrical currents applied to the scalp to influence brain activity without surgery.\n\nThe main questions this study aims to answer are:\n\n* How does TIEFS change brain signals measured with brain recordings?\n* Does TIEFS affect thinking abilities such as memory, language, movement, or perception?\n* Is TIEFS safe and well tolerated when used in people?\n\nThis study includes two groups of participants. One group includes adults with epilepsy who are already undergoing specialized brain monitoring as part of their medical care. The other group includes healthy adults with no history of seizures.\n\nParticipants will:\n\n* Receive brief sessions of TIEFS using electrodes placed on the scalp\n* Complete computer-based tasks that test memory, attention, language, or movement. Answer questions about how the stimulation feels\n* Have brain activity recorded during the study\n\nEach study visit lasts up to three hours and may occur in one or two sessions. Information from this study may help researchers better understand the human brain and support the development of future non-invasive brain stimulation treatments.",null,[18],"Epilepsy",[20],"Brain Stimulation","INTERVENTIONAL","BASIC_SCIENCE",[24],"NA",{"count":26,"type":27},15,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","Temporal Interference Electrical Stimulation","Temporal Interference Electrical Stimulation (TIEFS) is a non-invasive brain stimulation technique that uses two high-frequency electrical fields (\\>1 kHz) to generate an interference pattern at a specific brain region, creating a low-frequency envelope (Δf = f2 - f1) at the target depth. Unlike traditional stimulation methods, which affect only superficial brain regions, TIEFS can reach deeper structures without the need for implanted electrodes. The stimulation is applied through scalp electrodes. It has the potential for targeted brain interventions in both functional studies and clinical applications for neurological conditions.",[34,35],"Comparison of Active vs Sham TIEFS Stimulation in Healthy Subjects","Comparison of Active vs Sham TIEFS Stimulation in SEEG patients",[37],{"measure":38,"description":39,"timeFrame":40},"Brain activity changes during Stimulation","This outcome measures the changes in brain activity, either measured through scalp EEG electrodes (in Healthy Participant controls), or intracranial stereotaxic EEG electrodes (for SEEG pre-surgical evaluation epilepsy patients). Local field potential (LFP) power and EEG power in response to active TIEFS stimulation will be compared to sham stimulation. Electrical signals recorded from the brain reflect neural activity. Intracranial signals will be measured across different locations in the brain using implanted SEEG electrodes. Additionally, SEEG electrodes may have tetrodes tips to capture single neuron activity. We will compare how the brain's electrical activity changes during active TIEFS at various frequencies and during the sham stimulation to assess the impact on brain and neural function.","Measurements will be recorded throughout the stimulation session (lasting up to 90 minutes), with data collected before, during, and immediately after each stimulation.",[],"ALL","18 Years","65 Years",true,{"inclusion":47,"exclusion":52,"raw_text":56},[48,49,50,51],"Adult patients (age 18-65 years of age) undergoing an intracerebral electrophysiology study for epilepsy pre-surgical evaluation are eligible for inclusion.","For healthy control subjects are also eligible for inclusion (Scalp EEG measurements).","Participants must be able to sufficiently speak and understand English or Spanish for consent and be able to understand and complete cognitive tasks.","All subjects must have the ability to give valid informed consent.",[53,54,55],"No pregnant women will be recruited.","People with implanted electrical devices such as Deep Brain Stimulation devices or Pacemakers.","No prisoners will be recruited.","Inclusion Criteria:\n\n* Adult patients (age 18-65 years of age) undergoing an intracerebral electrophysiology study for epilepsy pre-surgical evaluation are eligible for inclusion.\n* For healthy control subjects are also eligible for inclusion (Scalp EEG measurements).\n* Participants must be able to sufficiently speak and understand English or Spanish for consent and be able to understand and complete cognitive tasks.\n* All subjects must have the ability to give valid informed consent.\n\nExclusion Criteria:\n\n* No pregnant women will be recruited.\n* People with implanted electrical devices such as Deep Brain Stimulation devices or Pacemakers.\n* No prisoners will be recruited.",[58,59],"ADULT","OLDER_ADULT",[61],{"facility":62,"status":7,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":75},"University of California Davis Medical Center","Sacramento","California","95817","United States",[68,73],{"name":69,"role":70,"phone":71,"email":72},"Nigel P Pedersen, MBBS","CONTACT","617-462-8120","nppedersen@health.ucdavis.edu",{"name":69,"role":74},"PRINCIPAL_INVESTIGATOR",{"lat":76,"lon":77},38.58157,-121.4944,[79,80],{"name":69,"role":70,"phone":71,"email":72},{"name":81,"role":70,"phone":82,"email":83},"Raul S Castillo-Astorga, MD","530-220-0057","rcastilloastorga@ucdavis.edu",[85],{"name":69,"affiliation":86,"role":74},"University of California Davis, School of Medicine, Neurology Department",[],[],{"nct_id":4,"conditions":90,"biomarkers":93},[91,92],"Healthy Volunteers","Seizure Disorder",[],{"nct_id":4,"found":45,"summary":95,"prompt_version":104},{"design":96,"status":97,"heading":6,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an interventional study, but the phase is not specified. It plans to enroll 15 participants, including adults with epilepsy and healthy volunteers.","completed","This study is looking at a non-surgical brain stimulation method called Temporally Interfering Electric Fields Stimulation (TIEFS). TIEFS uses electrical currents applied to the scalp to see how it affects brain activity and thinking. We want to understand how TIEFS changes brain signals, if it impacts abilities like memory or language, and if it's safe. Adults aged 18 to 65 can join. This includes people with epilepsy who are already having brain monitoring, and healthy volunteers. The study aims to see changes in brain activity during stimulation, which will be measured throughout the session (up to 90 minutes). The study is currently unclear on its recruitment status and plans to enroll 15 participants.","Measurements will be recorded throughout the stimulation session, with data collected before, during, and immediately after each stimulation.",113,"Measurements will be recorded throughout the stimulation session, which lasts up to 90 minutes. Data will be collected before, during, and immediately after each stimulation.","Not stated in the trial record.",[],"v2"]