[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644519":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":51,"centralContacts":55,"locations":65,"responsibleParty":79,"collaborators":60,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":60,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":108,"whyStopped":60,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University of Nottingham","OTHER",[8,15,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Open-loop transcranial low-intensity FUS","ACTIVE_COMPARATOR","Transcranial low intensity focused ultrasound stimulation (FUS) with 500kHz transducer for following either the continuous theta burst or intermittent theta burst protocol using the NeuroFus PRO system",[13,14],"Other: Transcranial low intensity focused ultrasound (FUS)","Procedure: Magnetic Resonance Imaging",{"label":16,"type":17,"description":18,"interventionNames":19},"Closed-loop transcranial low-intensity FUS","EXPERIMENTAL","Closed-loop Transcranial Electrical Stimulation by means of tACS or TI delivered through a Digitimer DS5 for brain entrainment phase-locked on peak or trough to transcranial low intensity FUS delivered to dACC through the NeuroFUS PRO system",[13,20,14],"Other: transcranial electrical stimulation",{"label":22,"type":10,"description":23,"interventionNames":24},"tES alone","tACS or TI delivered through a Digitimer DS5 for brain entrainment phase-locked on peak or trough",[20,14],{"label":26,"type":10,"description":27,"interventionNames":28},"Sham FUS","FUS delivered to ventricles or FUS and tACS located on head, one of them on or off depending on sham, or active.",[13,14],[30,38,44],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Transcranial low intensity focused ultrasound (FUS)","Low intensity focused ultrasound stimulation (FUS) with 500kHz transducer for following either the continuous theta burst or intermittent theta burst protocol using the NeuroFus PRO system",[16,9,26],[35,36,37],"LIFU","tFUS","TUS",{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"transcranial electrical stimulation","Transcranial electrical stimulation (by means of transcranial alternating current stimulation (tACS) or non-invasive temporal interference (TI) electrical stimulation) using the DS5 isolated bipolar constant current stimulator together connected to a wave generator and with two electrodes for tACS (TI implementation will be carried out with two DS5 systems, separate wave generators and four electrodes).",[16,22],[43],"tES",{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"PROCEDURE","Magnetic Resonance Imaging","We obtain baseline functional, metabolic and structural information through MRI and MRS scanning",[16,9,26,22],[50],"MRI",[52],{"name":53,"affiliation":5,"role":54},"Marcus Kaiser, PhD","PRINCIPAL_INVESTIGATOR",[56,62],{"name":57,"role":58,"phone":59,"phoneExt":60,"email":61},"Dr. Falcon Caro","CONTACT","+44 115 823 2866",null,"alicia.falconcaro@nottingham.ac.uk",{"name":63,"role":58,"phone":59,"phoneExt":60,"email":64},"Dr. Halls","Daniel.Halls@nottingham.ac.uk",[66],{"facility":5,"status":60,"city":67,"state":60,"zip":60,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Nottingham","United Kingdom","UK",{"type":71,"coordinates":72},"Point",[73,74],-1.15047,52.9536,{"lat":74,"lon":73},[77],{"name":78,"role":58,"phone":60,"phoneExt":60,"email":61},"Alicia Dr. Falcon Caro",{"type":54,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":60,"oldOrganization":60},"Marcus Kaiser","Professor of Neuroinformatics","100644519","closed-loop-tes-non-invasive-stimulation-100644519",false,"NCT07671079","Closed-loop tES-non-invasive Stimulation","Closed-loop Non-invasive Stimulation for Improving Brain and Mental Health in Healthy Individuals","CLIBM","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study\n* Aged between 18 and 40\n* Good general health\n* Not consume alcohol 48 hours prior study visit\n* Not currently taking any medications (except contraceptive pills) or if on long-term medication for a non-neurological\u002Fnon-psychiatric condition (r.g. inhalers) to be considered otherwise healthy and stable with no symptoms\n* Be right handedness\n\nExclusion Criteria:\n\n* Inability to complete MRI\u002FFUS\u002FTMS\u002FtES safety questionnaire and \u002F or informed consent process.\n* Current or previous diagnosis of a neurological, neurosurgical, psychiatric disorders.\n* Other significant medical condition (specific details to be reviewed by the CI prior to inclusion).\n* Currently pregnant, breast feeding, or on planned pregnancy.\n* Medication intake (such as beta-blocker, glucocorticoids, anti-depressants, anti-inflammatory drugs in the last 7d).\n* Medication intake (such as beta-blocker, glucocorticoids, anti-depressants) in the last 7d that are likely to affect brain function.\n* Significant use of medication or recreational drugs that affect the nervous system.\n* Excessive consumption of alcohol (\\>2 alcohol beverages per day).\n* Known allergy to any required consumables (such as aquasonic gel).\n* History of anaphylaxis to any substance\n* Have tightly coiled, curly or voluminous texture hair type (e.g., hair type 3, 4, or afro hair).\n* Having skin disease or sensitive skin on or close to the head.",true,"ALL","18 Years","40 Years",{"count":95,"type":96},30,"ESTIMATED","INTERVENTIONAL",[99],"NA","The goal of this study is to establish if non-invasive closed-loop neuromodulation is an effective approach to enhance cognitive function in healthy 18-40 years old volunteers. The main questions it aims to answer are:\n\n* Can closed-loop stimulation increase stimulation effectiveness?\n* Can closed-loop focused ultrasound specifically engage with excitatory or inhibitory neural populations in the target structure as measured through MRS?\n* Can observed stimulation outcomes for FUS be predicted through connectome analysis and computational models of indirect changes?\n\nResearchers will compare different closed-loop options to their open-loop counterpart to see if closed-loop approaches can increase efficacy and reduce the variability of the stimulation compared to open-loop approaches.\n\nParticipants will:\n\n* Answer some questionnaires at the start of the study and after each intervention session.\n* Undertake a MRI scanning session.\n* Undertake one open-loop FUS session.\n* Undertake one tES session.\n* Undertake one closed-loop FUS sessions involving tES and FUS, followed by a MRI scanning\n* Undertake one sham FUS session\n* Attend one visit in person to assess eligibility through questionnaires and one cognitive task",[102],"Closed-loop Brain Stimulation",[104,105,106,107],"neuromodulation","electrical stimulation","transcranial low-intensity focused ultrasound stimulation","closed-loop neuromodulation","NOT_YET_RECRUITING","2026-06-22",{"date":111,"type":112},"2026-06-26","ACTUAL",{"date":114,"type":96},"2026-07",{"date":116,"type":96},"2027-12",{"name":5,"class":6},1]