[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574941":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":66,"collaborators":70,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":26,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":26,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":97,"whyStopped":26,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Cardenal Herrera University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transcranial Magnetic Stimulation-Active Coil","EXPERIMENTAL","Patients in the experimental group will receive transcranial magnetic stimulation treatment using an active coil, cool-B70. The protocol to be administered is composed of 36 sessions that will be divided into two sessions per day, with a 50-minute break between sessions. For three months after the main treatment (protocol described above), a booster dose will be administered once a week.",[13],"Device: Repetitive Transcranial Magnetic Stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Transcranial Magnetic Stimulation-Sham coil","SHAM_COMPARATOR","The control group will receive the same protocol as the experimental group, with the main difference being that this group receives treatment through a placebo coil, MCF-P-B70. The placebo coil maintains the appearance and sound of the one that administers the active treatment, but differs from this in that it does not generate an effective magnetic field capable of generating depolarization in the stimulated brain area.",[19],"Device: Transcranial Magnetic Stimulation Sham",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Repetitive Transcranial Magnetic Stimulation","The protocol will be applied with the MagVenture R30 stimulation device and the cool-B70 coil for active treatment. The protocol will consist of two sessions per day, with a 50-minute break between sessions, every day of the week (Monday to Friday) for three and a half weeks (a total of 36 sessions). Each session will consist of the application of a 1Hz protocol (2000 pulses at 120% of the motor threshold) in the right dorsolateral prefrontal cortex (F4) followed by an intermittent theta-burst protocol (1800 pulses at 90% of the motor threshold) in the left dorsolateral prefrontal cortex (F3). The cortical target localization will be performed using the beam-F3\u002FF4 technique that combines different electroencephalographic positioning parameters and measurements to accurately locate said cortical targets. The motor threshold of each patient will be calculated at the beginning of each week of treatment using an electromyography system.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Transcranial Magnetic Stimulation Sham","The same protocol described in the intervention group will be carried out in the control group. The device used is the same, the difference is the coil that maintains the same appearance and generates the same sound as the active treatment coil, but unlike the latter, it does not produce an effective magnetization to depolarize the cerebral cortex on which we act.",[15],[32],{"name":33,"affiliation":5,"role":34},"Alejandro Fuertes, Associate Professor","STUDY_DIRECTOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Gonzalo Rafael Haro Cortés, Professor","CONTACT","+34 636993509","gonzalo.haro@uchceu.es",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Marta Badenes, Associate professor","+34 649466277","marta.badeneslengua@uchceu.es",[46],{"facility":47,"status":26,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Consorcio Hospitalario Provincial de Castellón","Castellon","Castellón","12002","Spain","ES",{"type":54,"coordinates":55},"Point",[56,57],-0.04935,39.98567,{"lat":57,"lon":56},[60,64],{"name":61,"role":38,"phone":62,"phoneExt":26,"email":63},"Iván Echeverria, Invitate Professor","+34 669948152","neuromodulacion@hospitalprovincial.es",{"name":65,"role":38,"phone":26,"phoneExt":26,"email":26},"Gonzalo Rafael Haró Cortés",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Gonzalo Rafael Haro Cortés","Medical specialist in Psychiatry. Head of the dual disorders program at the \"Hospital Provincial de Castellón\". Professor in the Department of Medicine and Surgery at the \"Universidad Cardenal Herrera-CEU\", CEU Universities.",[71],{"name":72,"class":6},"Hospital Provincial de Castellon","100574941","phase-3-transcranial-magnetic-stimulation-in-patients-with-dual-disorders-100574941",false,"NCT06765824","Transcranial Magnetic Stimulation in Patients with Dual Disorders","Transcranial Magnetic Stimulation in the Treatment of Dual Disorders: Study in Patients with Depression and Tobacco Addiction","Inclusion Criteria:\n\n* Patients over 18 years of age being monitored in the mental health area of the province of Castellón, with a dual disorder: major depression and substance abuse disorder\n* Patients who are refractory to two or more lines of pharmacological treatments, ensuring correct completion beforehand\n* Acceptance of informed consent\n\nExclusion Criteria:\n\n* Psychotic symptoms or catatonia\n* Other addictions, or psychiatric or personality disorders\n* Language barrier\n* Mental retardation that will interfere with the ability to understand and subsequent acceptance or rejection of informed consent\n* Patients diagnosed with epilepsy\n* Patients diagnosed with a space-occupying lesion in the brain\n* Tinnitus\n* Confirmed pregnancy; if suspected, a test will be requested\n* Metal piece in the body or implanted medical device, except for dental material","ALL","18 Years","65 Years",{"count":84,"type":85},36,"ESTIMATED","INTERVENTIONAL",[88],"PHASE3","According to the WHO, 280 million people are diagnosed with depression, the prevalence of which is almost twice as high in women as in men, with the incidence among young people increasing in recent years. Another public health problem in Spain is tobacco consumption, with one in four adults being tobacco users. The presence of an addiction and another mental illness in the same patient is called dual disorder, and it is very common for depression to be associated with smoking. This is due to a shared biopsychosocial vulnerability between the two disorders. Although there are currently pharmacological treatments that address both disorders, their efficacy is limited; in this sense, transcranial magnetic stimulation (TMS) offers a way to treat these dual disorders. TMS is a technique in which a magnetic field is applied to the cortex through a coil, generating an electric current that can induce changes in the different neurotransmitter systems, stimulating or inhibiting them. A randomised, double-blind, placebo-controlled clinical trial is proposed to evaluate the efficacy of TMS in the treatment of a sample of 36 patients with resistant major depression and nicotine dependence. Both depression and smoking will be assessed at baseline, at various times during treatment and at the end of the study using psychometric tests, neurophysiological and biochemical assessments. It is expected that the experimental group will show improvements in depression, nicotine dependence and certain cognitive functions. TMS treatment of dual disorders (resistant depression + smoking) could represent a health and social advance, especially for women.",[91,92],"Major Depression","Tobacco Addiction",[94,95,92,96],"Transcranial Magnetic Stimulation","Major depressive disorder","Dual disorder","NOT_YET_RECRUITING","2025-01-03",{"date":100,"type":101},"2025-01-09","ACTUAL",{"date":103,"type":85},"2025-02",{"date":105,"type":85},"2026-06",{"name":5,"class":6},1]