[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571007":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":35,"studyPopulation":35,"armGroups":45,"interventions":56,"overallOfficials":66,"centralContacts":70,"locations":35,"responsibleParty":78,"collaborators":35,"id":82,"slug":35,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":35,"enrollmentInfo":91,"targetDuration":35,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":104,"whyStopped":35,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":35},{"fullName":5,"class":6},"University of Catania","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Hamilton Depression Rating Scale - 17 (HDRS-17)","To investigate the effects of transcranial direct current stimulation (tDCS) treatment by administering Hamilton Depression Rating Scale - 17 (HDRS-17) on depressive symptoms in patients with depression, randomized into a \"test\" group and a \"sham\" group. Higher scores indicate greater severity of depressive symptoms, and thus a worse outcome.\n\nThe minimum and maximum scores and their meaning are as follows: 0-7: No clinically significant depression; 8-13: mild depression; 14-18: moderate depression; 19-22: severe depression; 23-52: very severe depression.","From enrollment to the end of treatment at 6 months",[14,17,20,23,26,29,32],{"measure":15,"description":16,"timeFrame":12},"Montreal Cognitive Assessment (MOCA)","To investigate the effects of tDCS treatment on cognitive function in patients with depression, randomized into a \"test\" group and a \"sham\" group.\n\nLower scores suggest greater cognitive impairment, while higher scores indicate better cognitive performance. Below are the minimum and maximum scores and their meaning: 30-26: normal cognitive function; 25-18: mild cognitive impairment; 17-10: moderate cognitive impairment; 9-0: severe cognitive impairment.",{"measure":18,"description":19,"timeFrame":12},"Frontal Assessment Battery (FAB)","To investigate the effects of tDCS treatment on cognitive function in patients with depression, randomized into a \"test\" group and a \"sham\" group. Specifically, FAB is a tool used to evaluate frontal lobe functions, such as executive functioning. Lower scores suggest greater impairment of frontal lobe functions, while higher scores indicate better functioning. Below are the minimum and maximum scores and their meaning: 18-15: normal frontal lobe functioning; 14-12: mild impairment; 11-9: moderate impairment; 9-0: severe impairment.",{"measure":21,"description":22,"timeFrame":12},"Apathy Evaluation Scale (AS)","To investigate the effects of tDCS treatment on cognitive function in patients with depression, randomized into a \"test\" group and a \"sham\" group. AS is a tool used to assess the presence of apathy in patients. Higher scores suggest greater severity of apathy, while lower scores indicate better motivation and engagement. Below are the minimum and maximum scores and their meaning: 18-27: no clinically significant apathy; 28-41: mild apathy; 42-55: moderate apathy; 56-72: severe apathy.",{"measure":24,"description":25,"timeFrame":12},"Stroop Color Test","To investigate the effects of tDCS treatment on cognitive function in patients with depression, randomized into a \"test\" group and a \"sham\" group. Stroop Color Test is a neuropsychological tool used to assess cognitive flexibility, selective attention and processing speed. Performance is assessed by comparing raw scores to normative data adjusted for age, education and cultural background. Minimum score (0) indicates no ability to perform the task; on the other hand, there is no universal maximum score. Tipically, performance is categorized into a normal range when it is consistent with age-matched norms; mild impairment when the performance is slightly below expectations for age or education; moderate to severe impairment when patient shows significant difficulty with cognitive control or selective attention.",{"measure":27,"description":28,"timeFrame":12},"To evaluate changes in blood biomarkers after tDCS treatment","A blood sample is collected at enrollment and after tDCS\u002Fsham treatment to evaluate biomarkers, including BDNF, NGF, VEGF, IGF1, Ang, Nrg1, IL-6, and TNFα.\n\nConcentrations will be reported in pg\u002FmL or ng\u002FmL, as appropriate for each biomarker.",{"measure":30,"description":31,"timeFrame":12},"To evaluate changes in cerebral hemodynamics after tDCS treatment","A transcranial Doppler (TCD) exam is conducted to assess cerebral hemodynamics. Parameters including VPS (cm\u002Fs), EDV (cm\u002Fs), MBFV (cm\u002Fs), PI (unitless), and RI (unitless) are recorded bilaterally from the middle cerebral arteries and the basilar artery, both at rest and after breath-holding tests. Measurements will be reported in their respective units (e.g., cm\u002Fs for velocities, unitless for indices).",{"measure":33,"description":34,"timeFrame":12},"To evaluate changes in Cortical Excitability Using TMS","Cortical excitability is evaluated using transcranial magnetic stimulation (TMS) with single- and double-pulse protocols. Parameters include:\n\nResting motor threshold (rMT, % of maximum stimulator output); Cortical silent period (cSP, milliseconds); Motor evoked potential (MEP, µV); Paired-pulse stimulation (BiSTIM) is used to study inhibitory and excitatory circuits, including intracortical inhibition (ICI) and intracortical facilitation (ICF).\n\nResults are reported in their respective units (e.g., % stimulator output for rMT, ms for cSP, µV for MEP).",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":35,"primaryPurpose":39,"observationalModel":35,"timePerspective":35,"maskingInfo":40},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":41,"maskingDescription":35,"whoMasked":42},"DOUBLE",[43,44],"PARTICIPANT","OUTCOMES_ASSESSOR",[46,51],{"label":47,"type":48,"description":35,"interventionNames":49},"active","EXPERIMENTAL",[50],"Device: Active tDCS",{"label":52,"type":53,"description":35,"interventionNames":54},"sham","SHAM_COMPARATOR",[55],"Device: Sham treatment",[57,62],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":35},"DEVICE","Active tDCS","The active tDCS protocol consist of 15 excitatory tDCS sessions distributed over 3 weeks (5 sessions per week, from Monday to Friday), at the same time each day, administered by the same operators and under identical experimental conditions. Each session last 30 minutes, with the Anode electrode placed on the left dorsal lateral prefrontal cortex (DLPFC) and the Cathode electrode on the right DLPFC at an intensity of 2 mA. The electrodes are positioned according to the 10-20 electroencephalography system (Anode on F3 and Cathode on F4).",[47],{"type":58,"name":63,"description":64,"armGroupLabels":65,"otherNames":35},"Sham treatment","The sham-tDCS intervention consist of a placebo 15 tDCS sessions distributed over 3 weeks (5 sessions per week, from Monday to Friday), at the same time each day, administered by the same operators and under identical experimental conditions. Each session last 30 minutes, with the Anode electrode placed on the left dorsal lateral prefrontal cortex (DLPFC) and the Cathode electrode on the right DLPFC. During the sessions only a 15-second initiation current is applied, providing the patient with the sensation of receiving an electric current on the scalp. Participants will also experience sounds and stimuli similar to those produced by active tDCS.",[52],[67],{"name":68,"affiliation":5,"role":69},"Maria Salvina Signorelli, MD PhD","PRINCIPAL_INVESTIGATOR",[71,75],{"name":68,"role":72,"phone":73,"phoneExt":35,"email":74},"CONTACT","3498127364","maria.signorelli@unict.it",{"name":76,"role":72,"phone":35,"phoneExt":35,"email":77},"Carmen Concerto, MD PhD","c.concerto@policlinico.unict.it",{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"SPONSOR_INVESTIGATOR","Carmen Concerto","PhD, MD","100571007",false,"NCT06714643","Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder","Antidepressant and Related Neurophysiological Effects of Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder","NIBS_tDCS","Inclusion criteria:\n\n* Patients with Major Depressive Disorder (MDD), as defined by the DSM-5-TR criteria;\n* Presence of residual symptoms, defined by a Hamilton Depression Rating Scale score over 7;\n* Age over 18 years.\n\nExclusion criteria:\n\n* MMSE under 18 and\u002For CDR over 2;\n* Other neurological diseases (stroke, multiple sclerosis, major head trauma, epilepsy) or psychiatric disorders other than those included (schizophrenia, bipolar disorder, etc.);\n* Patients with severe clinical conditions, acute or uncontrolled chronic medical diseases;\n* Endocrine diseases, vitamin deficiencies, or exposure to drugs associated with cognitive impairment and\u002For mood deflection;\n* Alcohol abuse or recreational drug use;\n* Contraindications to MRI and TMS (carriers of implanted devices, patients who have undergone craniotomy, presence of metal fragments or prostheses, history of epilepsy);\n* Pregnant or breastfeeding women.","ALL","19 Years",{"count":92,"type":93},105,"ESTIMATED","INTERVENTIONAL",[96],"NA","Introduction The study involves the recruitment of outpatients suffering from Major Depressive Disorder (MDD), diagnosed according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Patients are on selective serotonin reuptake inhibitors (SSRIs) for at least 4 weeks and present residual depressive symptoms, defined by a score greater than 7 on the Hamilton Depression Rating Scale (HDRS-17).\n\nStudy Objectives\n\nPrimary Objective To investigate the effects of transcranial direct current stimulation (tDCS) on depressive symptoms in patients with depression, randomized into a \"test\" group and a \"sham\" group.\n\nSecondary Objectives\n\nTo investigate the effects of tDCS on cognitive function in patients with depression, randomized into a \"test\" group and a \"sham\" group.\n\nTo evaluate changes in blood biomarkers, neurophysiological, and neurosonological variables after tDCS treatment in the same group of patients.",[99],"Major Depressive Disorder (MDD)",[101,102,103],"tDCS","MD","Biomarkers","NOT_YET_RECRUITING","2024-11-28",{"date":107,"type":108},"2024-12-03","ACTUAL",{"date":110,"type":93},"2025-01-02",{"date":112,"type":93},"2026-01-02",{"name":80,"class":6}]