[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ITAB - Institute for Advanced Biomedical Technologies\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100500583","translational-biomarkers-in-accelerated-neuromodulation-for-treatment-resistant-depression-100500583",false,"NCT05798143","Translational Biomarkers in Accelerated Neuromodulation for Treatment-resistant Depression","Developing Translational Biomarkers to Predict Clinical Response in Treatment-resistant Depression: Towards a Personalized, Plasticity-enhancing Accelerated Neuromodulation","ReModula","Inclusion Criteria:\n\n* Current diagnosis of Major Depressive Disorder (MDD), based on the Diagnostic and Statistical Manual of Mental Disorder - Fifth Edition (DSM-5);\n* Subjects without clinical response to at least two antidepressant treatments administered at adequate dosage and duration during the current episode;\n* Stable psychopharmacological treatment for at least one month.\n\nExclusion Criteria:\n\n* Co-morbidity with organic diseases that could interfere with magnetic stimulation safety (epilepsy, brain lesions or diseases, previous neurosurgery, metal grafts, cardiac devices) based on applied procedure guidelines;\n* Diagnosis of Substance or Alcohol Use Disorder (DSM-5) in the past 6 months;\n* Substances of abuse or alcohol acute intoxication or abstinence;\n* Co-morbidity with significant organic or neurological diseases;\n* Personal or familiar (1st degree relatives) medical history of seizures;\n* Significant eye diseases that could interfere with ERG execution;\n* For female patients: Pregnancy\u002Fbreastfeeding.","ALL","18 Years","65 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"NA","Background: 30-50% of patients with Major Depressive Disorder (MDD) do not respond adequately despite two or more antidepressant treatments with proper dosage and timing of administration, configuring a condition of Treatment-Resistant Depression (TRD). Repetitive Transcranial Magnetic Stimulation (rTMS) is a neuromodulation technique that uses a magnetic field to stimulate focal cortical brain regions and it has been approved by the FDA for the treatment of TRD. Accelerated rTMS (arTMS) protocols involve multiple daily sessions of rTMS and they have been shown to be equally effective and safe compared to rTMS protocols, with reduced administration time and potentially faster antidepressant efficacy.\n\nObjectives: The main aim of this study is to identify MDD endophenotypes\u002Fbiotypes predictive of response to accelerated treatment of rTMS to better characterize the clinical correlates of response in patients with TRD.\n\nEligibility: Subjects between 18 and 65 years suffering from TRD in stable psychopharmacological treatment for at least one month.\n\nDesign: This clinical trial includes three phases: 1) a screening phase; a rTMS continued treatment phase; and a follow-up.\n\nIn order to be enrolled, participants will be screened with:\n\n* Medical history to assess the existence of the inclusion criteria and exclude any medical conditions that could contraindicate treatment with arTMS\n* Questionnaires\n\nAfter being enrolled, baseline data will be collected. In particular, participants will be administered:\n\n* Questionnaires\n* Functional MRI\n* Cognitive tasks\n* Eye examination with Electroretinography (ERG)\n* Blood sampling\n* Salivary cortisol sampling\n\nRepetitive TMS will be delivered during 5 outpatient treatment days (4 times\u002Fdie).\n\nAfter treatment patients will be contacted by telephone on a weekly basis for the first 3 weeks, to carry out an assessment of the clinical condition.\n\nA follow-up visit, in the clinic, will be carried out after 21 days from the last stimulation (Friday), with the administration of psychometric scales.\n\nBlood samples will be taken on the first day of stimulation and the day after the last stimulation.\n\nSalivary cortisol sampling will be taken before the start of the stimulation protocol, after the first stimulation day and immediately after the last stimulation session foreseen by the protocol.\n\nfMRI will be performed during baseline and at the end of treatment. ERG will be performed before the start of the stimulation protocol, after the first stimulation and immediately after the last stimulation session foreseen by the protocol. Patients will undergo ERG again during the follow-up visit at 21 days.\n\nTreatment includes:\n\n* rTMS: A brief electrical current passes through the coil placed on the head. At each day, participants will receive four rTMS sessions (36 min), with a 55 min interval between sessions.\n* MRIs: Patients will undergo two MRI sessions lasting 45 min. Blood pressure and respiratory rate will be recorded before the examination. During fMRI, patients will be asked to perform tasks.\n* Eye examination with Electroretinography (ERG)\n* Blood and salivary sampling.\n* Screening tests and questionnaires.",[28],"Treatment Resistant Depression",[30,31,32,33,34,35],"Treatment resistant depression","accelerated repetitive transcranial magnetic stimulation","arTMS","TRD","biomarkers","neuroplasticity","RECRUITING","2023-04-03",{"date":39,"type":40},"2023-04-04","ACTUAL",{"date":42,"type":40},"2023-02-28",{"date":44,"type":22},"2028-12-31",{"name":46,"class":47},"ITAB - Institute for Advanced Biomedical Technologies","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":68,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":4},"100431377","neurobiological-effects-of-transcranial-direct-current-stimulation-treatment-in-alcohol-use-disorder-100431377","NCT04897295","Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder","Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder: a Sham-controlled Trial.","Inclusion Criteria:\n\n* diagnosis of Alcohol Use Disorder (at least 12 months);\n* drug free\u002Fstable psychopharmacological therapy (one month), with the exception of guidelines treatments for alcoholic abstinence (treatment-as-usual);\n* any assumption of substances for at least 48 hours.\n\nExclusion Criteria:\n\n* presence of organic pathologies (capable of interfering with the safety of the procedure) in comorbidities;\n* presence of intellectual disability;\n* history of epileptic seizures (also in first degree relatives);\n* score\\> 12 on the Young Mania Rating Scale (Y-MRS).",{"count":57,"type":22},30,[25],"Background: Alcohol Use Disorder (AUD) is a complex psychiatric disorder, involving several brain areas and neurocircuits. Transcranial Direct Current Stimulation (tDCS) allows to stimulate superficial areas of brain using a weak electrical current. Preliminary data suggest that tDCS may reduce alcohol craving and consumption.\n\nObjectives: The main outcome is to test if tDCS can reduce alcohol craving and use and to assess the changes in BDNF and pro-BDNF levels. Secondary outcomes are the assessment of other psychiatric dimensions (mood, behavioral and cognitive alterations) associated with prolonged alcohol use.\n\nEligibility: Healthy, right-handed adults ages 18-65 who do have AUD (moderate to severe).\n\nDesign: This is a randomized, double-blind, sham-controlled study with three phases: 1) a tDCS intensive treatment phase; 2) follow-up with weekly tDCS stimulation; 3) follow-up without tDCS stimulation.\n\nParticipants will be screened with:\n\n* Psychometric Scales\n* Medical history\n* Physical exam\n* Urine tests and breathalyzer\n* After being enrolled, baseline behavioral and laboratory data will be collected. In particular, participants will undergo:\n* Psychometric Scales\n* Venous blood sample (BDNF\u002FproBDNF levels)\n\nParticipants will be randomized to real or sham tDCS arm. The stimulation will be delivered daily for five days during the first week (intensive treatment phase) and then weekly for 3 months (follow-up with stimulation). During this period patient will be tested with a behavioral and psychometric evaluation.Therefore, participants will receive 3 follow-up monthly visits without tDCS stimulation, in which behavioral and psychometric data will be collected.\n\nTreatment includes:\n\n* tDCS: The tDCS will be delivered with a stimulator connected to two sponge electrodes, soaked in a saline solution. The stimulation will be administered at a current intensity of approximately 1 mA, for the duration of 20 minutes. The anode will be placed on the right DLPFC, the cathode on the contralateral cortical area.\n* BDNF\u002FproBDNF levels: A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period (first week). The blood sample will be centrifuged within 20 minutes of sampling at 1000 × g for 15 minutes. Then, the serum will be aliquoted and stored at -80 ° C until analysis.\n* Repeat of screening tests and questionnaires\n* Urine toxicological screen and breathalyzer",[61,62,63,64,65,66,67],"Alcohol Use Disorder (AUD)","Alcohol Abuse","Alcohol Dependence","Alcohol-Related Disorders","Drug Abuse","Substance Use Disorders","Mental Disorder",[69,70,71,72,73,74],"Alcohol Use Disorder","transcranial Direct Current Stimulation","Non-Invasive Brain Stimulation","Craving","Brain Derived Neurotrophic Factor","Pro-Brain Derived Neurotrophic Factor","NOT_YET_RECRUITING","2021-10-25",{"date":78,"type":40},"2021-10-26",{"date":80,"type":22},"2021-12-01",{"date":82,"type":22},"2026-11-30",{"name":46,"class":47},""]