[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596101":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":24,"centralContacts":35,"locations":45,"responsibleParty":67,"collaborators":71,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":24,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":48,"whyStopped":24,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Corporacion Parc Tauli","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Neurofeedback (EEG-NF)","EXPERIMENTAL","Participants in this arm will receive 10 sessions of active EEG-based neurofeedback over 5 weeks, while continuing their standard pharmacological treatment. Neurofeedback will be delivered using swLORETA Z-score training via NeuroGuide software, targeting key regions of the fronto-limbic emotional regulation network (e.g., anterior cingulate cortex, medial prefrontal cortex, amygdala, insula).",[13],"Device: Active swLORETA Z-score Neurofeedback",{"label":15,"type":16,"description":17,"interventionNames":18},"Yoked-sham Neurofeedback","SHAM_COMPARATOR","Participants in this arm will undergo 10 sessions of sham neurofeedback with the same structure, duration, and appearance as the active intervention, while continuing their standard pharmacological treatment. However, the feedback presented on screen will be non-contingent and based on pre-recorded EEG activity from a participant in the active group (yoked design). This design ensures participants receive no real-time modulation of their own brain activity, serving as a placebo control while preserving participant blinding. After completing the study, these participants will be offered the opportunity to receive the active neurofeedback intervention in a separate phase.",[19],"Device: Yoked-sham swLORETA Z-score Neurofeedback",{"label":21,"type":22,"description":23,"interventionNames":24},"Treatment as Usual (Control)","NO_INTERVENTION","Participants in this arm will continue their standard pharmacological treatment without receiving any additional intervention during the study period. This group serves as a control condition to assess the effects of neurofeedback relative to usual care.",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"DEVICE","Active swLORETA Z-score Neurofeedback","Participants receive 10 sessions (25 minutes each, twice per week for 5 weeks) of EEG-based neurofeedback using the NeuroGuide® software and a 24-channel EEG recording system (eego™, ANT Neuro). The neurofeedback protocol is based on real-time swLORETA Z-score training targeting brain regions involved in emotion regulation. Feedback is provided via gamified visual displays when EEG activity moves toward normative patterns. This is an operant conditioning-based protocol designed to enhance emotional self-regulation.",[9],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":24},"Yoked-sham swLORETA Z-score Neurofeedback","Participants receive 10 sessions identical in appearance and duration to the active neurofeedback condition. However, the feedback provided is not based on their own EEG activity. Instead, it is pre-recorded data from a matched participant in the active group (\"yoked\" design), ensuring no real-time neurophysiological modulation occurs. The same EEG equipment and visual feedback interface are used to maintain blinding.",[15],[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Virginia Soria, MD,PhD","CONTACT","+34 937231010","82711","vsoria@gmail.com",{"name":43,"role":38,"phone":39,"phoneExt":40,"email":44},"Diego Palao, MD, PhD","dpalao@tauli.cat",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Corporació Sanitària Parc Taulí de Sabadell","RECRUITING","Sabadell","Barcelona, Cataluña","08208","Spain","ES",{"type":55,"coordinates":56},"Point",[57,58],2.10942,41.54329,{"lat":58,"lon":57},[61,63,64],{"name":62,"role":38,"phone":39,"phoneExt":40,"email":41},"Virginia Soria, MD, PhD",{"name":43,"role":38,"phone":39,"phoneExt":40,"email":44},{"name":65,"role":66,"phone":24,"phoneExt":24,"email":24},"Eleonora De Filippi, PhD","SUB_INVESTIGATOR",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Virginia Soria","Head of Adults Mental Health Department",[72],{"name":73,"class":6},"Horizon 2020 - European Commission","100596101","eeg-based-neurofeedback-to-improve-emotion-regulation-in-major-depressive-disorder-a-randomized-clinical-trial-100596101",false,"NCT07041073","EEG-based Neurofeedback to Improve Emotion Regulation in Major Depressive Disorder: A Randomized Clinical Trial","Restoring Emotional Stability Through Neurofeedback and AI for Transformative Empowerment","RESoNATE","Inclusion Criteria:\n\n* A primary diagnosis of Major Depressive Disorder (MDD), established by qualified psychiatrists according to DSM-5 criteria.\n* Patients with comorbid anxiety or anxiety symptoms will be included, provided that MDD is the primary diagnosis.\n* Participants must score at least 20 on the Montgomery-Åsberg Depression Rating Scale (MADRS), indicating a moderate level of depression.\n* All participants must be on a stable psychopharmacological treatment for at least 6 weeks before beginning of the study.\n\nExclusion Criteria:\n\n* Patients with a concurrent diagnosis of MDD and other severe psychiatric disorders.\n* Patients with serious physical illnesses that could interfere with study participation or the interpretation of results.\n* Participants currently undergoing structured psychotherapy or other interventions unrelated to standard psychopharmacological treatment.\n* Patients presenting with active suicidal ideation, as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS), at the time of screening will not be eligible due to associated risks.\n* Active substance abuse or dependence (except nicotine).\n* Intellectual disability or conditions that interfere with the ability to provide informed consent and complete the intervention (e.g., severe visual or hearing impairments).\n* Pregnancy.","ALL","18 Years","65 Years",{"count":86,"type":87},72,"ESTIMATED","INTERVENTIONAL",[90],"NA","The goal of this clinical trial is to evaluate whether EEG-based neurofeedback targeting the emotion regulation network through swLORETA can improve emotional regulation and reduce symptoms in adults with Major Depressive Disorder (MDD) who have not responded sufficiently to first-line treatments. The main questions it aims to answer are:\n\n* Does EEG-neurofeedback improve emotional self-regulation and reduce clinical symptoms in patients with MDD with or without anxiety symptoms?\n* Are changes in EEG resting-state activity and stress biomarkers (e.g., cortisol) associated with clinical improvement?\n\nResearchers will compare an active neurofeedback group, a sham (placebo) neurofeedback group, and a treatment-as-usual control group to see if real-time EEG-neurofeedback leads to greater improvement in mood, emotional regulation, and neurophysiological indicators than placebo or no additional intervention.\n\nParticipants will:\n\n* Receive 10 sessions of either real or sham EEG-neurofeedback (or no sessions in the control group) over 5 weeks.\n* Complete clinical, psychological, and neurophysiological assessments before (week 0) and after the intervention (week 6).\n* Provide repeated saliva samples to assess stress-related biomarkers at week 0 and week 6.\n* Continue their standard pharmacological treatment throughout the study.",[93,94],"Major Depression With Comorbid Anxiety Symptoms","Major Depressive Disorder (MDD)",[96,97,98,99,100,101],"neurofeedback","eeg","MDD","anxiety","depression","emotion regulation","2025-06-18",{"date":104,"type":105},"2025-06-27","ACTUAL",{"date":107,"type":105},"2025-05-19",{"date":109,"type":87},"2026-09",{"name":5,"class":6},1]