[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"IRCCS Centro San Giovanni di Dio Fatebenefratelli\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":284},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,42,70,103,125,156,182,205,231,254],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100631830","transcranial-alternating-current-stimulation-in-frontotemporal-dementia-100631830",false,"NCT07505784","Transcranial Alternating Current Stimulation in Frontotemporal Dementia","Cross-over Study to Evaluate the Safety, Tolerability, and Clinical Efficacy of Transcranial Alternating Current Stimulation (tACS) in Patients With Frontotemporal Dementia","BetaTACSFTD","Inclusion Criteria:\n\n* Male or female subjects aged over 40 years at the time of signing the informed consent form;\n* Presence of a clinical diagnosis of Frontotemporal Dementia according to clinical criteria (Rascovsky et al., 2011; Gorno-Tempini et al., 2011).\n\nExclusion Criteria:\n\n* Age younger than that stated in the inclusion criterion;\n* Inability to understand;\n* Contraindications for tACS and TMS: cardiac pacemaker carriers and metal implants that are not compatible with electric or magnetic fields, history of epilepsy, current pregnancy (Safety Questionnaire)","ALL","40 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","The aim of the study is to evaluate the safety, feasibility, clinical and biological efficacy, and predictors of efficacy of an intervention consisting of transcranial alternating current stimulation (tACS) in patients with Frontotemporal Dementia (FTD).\n\nIn addition to typical symptoms, FTD also present alterations in brain oscillations. In animal models of neurodegeneration, restoration of oscillations via neuronal \"entrainment\" phenomena has demonstrated a significant reduction in toxic protein accumulation, resulting in improved cognitive function.\n\ntACS is a neurophysiological noninvasive method of neuromodulation increasingly studied for its therapeutic potential. It has been shown to safely modulate the oscillatory frequencies underlying multiple cognitive functions, including verbal memory, perception, and working memory.\n\nIn light of this evidence, it is proposed to apply a single-session treatment of β-tACS stimulation in patients with FTD and to evaluate its clinical effects, oscillatory modifications by EEG, and changes in neurophysiological indices such as short intracortical inhibition (SICI) and intracortical facilitation (ICF), both compromised in the disease.\n\nThe study has a cross-over design (multicenter, randomized, placebo-controlled and double-blind), with FTD patients randomly assigned to one of the two arms: i) Group 1, who will receive a real tACS session first (1h); ii) Group 2, who will instead undergo a sham tACS session (1h). In the next phase (cross-over), one week after the first phase, the groups will reverse the treatment: Group 1 will receive tACS sham and Group 2 will receive real tACS.\n\nThe main objectives of the study are: \\[1\\] to evaluate the safety and tolerability of the single tACS treatment session; \\[2\\] to investigate the effects of the protocol on (short-term) cognitive performance in patients with FTD; \\[3\\] to verify intervention-induced changes in brain synchronization; \\[4\\] to evaluate changes in neurophysiological indices following treatment; and \\[5\\] evaluate any predictors of efficacy.",[27,28],"Transcranial Alternating Current Stimulation","Frontotemporal Dementia (FTD)","RECRUITING","2026-03-26",{"date":32,"type":33},"2026-04-01","ACTUAL",{"date":35,"type":33},"2026-02-03",{"date":37,"type":21},"2027-02",{"name":39,"class":40},"IRCCS Centro San Giovanni di Dio Fatebenefratelli","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":41},"100631182","effects-of-specific-amino-acid-supplementation-and-lifestyle-factors-on-brain-ageing-100631182","NCT07497347","Effects of Specific Amino Acid Supplementation and Lifestyle Factors on Brain Ageing","Translational Investigation of Specific Amino Acid Supplementation and Lifestyle Factors in Brain Ageing","AAAgeing","Inclusion Criteria:\n\n* Age 65-85 years;\n* Presence of depressive symptoms, defined as a score ≥ 5 on the Geriatric Depression Scale-15 items (GDS-15) or ≥ 5 on the Patient Health Questionnaire-9 (PHQ-9).\n\nExclusion Criteria:\n\n* Diagnosis of dementia;\n* Use of antibiotics or anti-inflammatory medications within the previous 8 weeks;\n* Active gastrointestinal disease;\n* Severe chronic medical conditions (e.g., advanced-stage cancer, severe cardiac or renal disorders, or other debilitating diseases);\n* Renal dysfunction;\n* Current alcohol or substance abuse;\n* Major surgical procedures within the previous 6 months.","65 Years","85 Years",{"count":53,"type":21},84,[24],"The aim of this clinical trial is to investigate the effects of L-serine supplementation on cognitive decline and psychosocial functioning in older adults with late-life depression (LLD). The study will evaluate changes in depressive symptoms, neural and cognitive functioning, and will assess neurophysiological, metagenomic, and biochemical alterations associated with L-serine supplementation compared with placebo.\n\nThe main research questions are:\n\n* Does L-serine supplementation affect cognitive function, depressive symptoms, and neural functioning in individuals with late-life depression?\n* What biological mechanisms may underlie the effects of L-serine on cognitive decline? Participants will be randomly assigned to one of two study arms: an intervention group (total n = 42) receiving L-serine at a dose of 6 g\u002Fday for 48 weeks, and a placebo group (total n = 42) receiving 6 g\u002Fday of maltodextrin for the same duration.\n\nAll participants will be assessed at three time points: T0 (baseline, prior to trial initiation), T18 (after 18 weeks), and T48 (after 48 weeks, at the end of the trial).\n\nAt each assessment, participants will:\n\n* complete clinical questionnaires and a neuropsychological assessment;\n* provide blood, fecal, and urine samples;\n* undergo electroencephalographic (EEG) recordings.",[57],"Late-Life Depression",[59,60,61],"Late-life depression","L-serine supplementation","Ageing- related Cognitive Decline","2026-03-24",{"date":64,"type":33},"2026-03-27",{"date":66,"type":33},"2026-03-01",{"date":68,"type":21},"2029-02-01",{"name":39,"class":40},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":91,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":41},"100593652","lifestyle-interventions-to-prevent-cognitive-deficits-in-subjects-with-depressive-symptoms-from-mechanisms-to-clinical-practice-100593652","NCT07009223","Lifestyle Interventions to Prevent Cognitive Deficits in Subjects With Depressive Symptoms: From Mechanisms to Clinical Practice","Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice","POWER","Inclusion Criteria:\n\n* Aged between 50 and 80 years;\n* Diagnosis of DDM according to DSM-5 or depressive symptoms (PHQ-9 or GDS-15 ≥ 5, the choice of test will be justified by the participant's age);\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Active gastrointestinal disorders;\n* Autoimmune disorders;\n* Chronic inflammatory disorders;\n* Diagnosis of dementia; cognitive impairment or mild functional impairment.\n* Use of antibiotics and\u002For anti-inflammatory drugs in the 8 weeks prior to the screening visit.","50 Years","80 Years",{"count":81,"type":21},120,[24],"The goal of this clinical study is to investigate if lifestyle changes can help prevent cognitive decline and reduce depressive symptoms in people between the ages of 50 and 80 with depressive symptoms or a diagnosis of major depression, but without signs of cognitive decline.\n\nThe main questions it aims to answer are:\n\n* Does regular physical activity improve mood and memory in people who are depressed or have depressive symptoms?\n* Does cognitive training help prevent mental difficulties in people at risk of cognitive decline?\n* Do changes in diet and lifestyle alter the composition of the gut microbiota and immuno-related infiammatory factors?\n\nResearchers will compare three different treatment groups to see which intervention is most effective in improving mental and cognitive health.\n\nThe participants:\n\n* Will take part to online sessions on healthy eating based on the Mediterranean diet\n* Some will do regular exercise, supervised by a personal trainer\n* Others will do weekly cognitive training in small groups at the hospital\n* They will provide blood and fecal samples and complete cognitive tests and clinical questionnaires at the beginning, at the end of the treatment (12 weeks), and after 3 months.",[85,86,87,88,89,90],"Major Depressive Disorder (MDD)","Physical Activity","Inflammation","Metabolome","Gut Microbiota","Depressive Symptoms",[92,93,94],"Depression","Cognition","nutrition","2026-02-09",{"date":97,"type":33},"2026-02-11",{"date":99,"type":33},"2025-10-01",{"date":101,"type":21},"2028-03",{"name":39,"class":40},{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":111,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":122,"leadSponsor":124,"locationsCount":41},"100621834","transcranial-alternating-current-stimulation-in-lewy-body-dementia-100621834","NCT07375771","Transcranial Alternating Current Stimulation in Lewy Body Dementia","Interventional Study to Evaluate the Effectiveness of Transcranial Alternating Current Stimulation (tACS) on Cognitive Performance in Patients With Lewy Body Dementia","TACSDLB2","Inclusion Criteria:\n\n* Male or female subjects aged over 18 at the time of signing the informed consent form;\n* Presence of a clinical diagnosis of Lewy body dementia according to clinical criteria (McKeith et al., 2017)\n\nExclusion Criteria:\n\n* Age younger than that stated in the inclusion criteria;\n* Incapacity to understand;\n* Contraindications for tACS and TMS: patients with cardiac pacemakers and metal implants that are not compatible with electric or magnetic fields, history of epilepsy, current pregnancy (Safety questionnaire)","18 Years",{"count":113,"type":21},40,[24],"The aim of the study is to evaluate the safety, feasibility, clinical and biological efficacy, and predictors of efficacy of an intervention consisting of transcranial alternating current stimulation (tACS) in patients with Lewy Body Dementia (DLB).\n\nIn neurodegenerative diseases, like DLB, the process of neurodegeneration is accompanied by a significant alteration in oscillatory activity.\n\ntACS is a neurophysiological method of non-invasive modulation of the excitability of the central nervous system that uses a mild electrical current. Recent studies have demonstrated the safety and efficacy of this method in modulating the natural brain oscillation frequencies underlying multiple cognitive processes, such as verbal memory, perception, and working memory. Preliminary data show that single stimulation with occipital α-tACS results in a significant improvement in visuospatial abilities and executive functions in patients wih DLB.\n\nThe study is double blind, randomised and placebo-controlled, participants will be randomised into two groups: group 1, participants will receive real tACS for 2 weeks, from Wednesday to Tuesday (5 sessions\u002Fweek, lasting approximately 60 minutes each); and group 2, participants will receive placebo tACS for 2 weeks (5 sessions\u002Fweek, lasting approximately 60 minutes each).\n\nVisits will take place at the beginning of the study (T00), after 2 weeks (T02), and 12 weeks (T12, follow-up). During each visit, participants undergo the following procedures: (i) blood sampling, (ii) clinical and neuropsychological assessment, (iii) EEG, and (iv) TMS-EEG. The occurrence of adverse events will be monitored throughout the duration of the study. Specific biomarker analyses will be performed on the blood samples to study the pathophysiological mechanisms of the disease and the effect of the experimental intervention.",[117,27],"Lewy Body Dementia (LBD)","2026-01-21",{"date":120,"type":33},"2026-01-29",{"date":99,"type":33},{"date":123,"type":21},"2030-09",{"name":39,"class":40},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":133,"sex":17,"minAge":111,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":141,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},"100586380","real-time-experiences-physical-activity-and-biological-outcomes-in-personal-recovery-residents-empower-res-100586380","NCT06914622","Real-time Experiences, Physical Activity and Biological Outcomes in Personal Recovery Residents (EMPOWER-RES)","Real-Time Experiences, Physical Activity And Biological Outcomes In Personal Recovery Of Residents With Mental Disorders (EMPOWER-RES): A Non-Randomized Multicentric Clinical Trial","EMPOWER-RES","The study population will include:\n\nPatients with a mental disorder inclusion criteria:\n\n* diagnosis of a mental disorder according to DSM5TR,\n* receiving treatment at an SRP of the recruiting centers,\n* over 18 years old, willing to participate exclusion criteria:\n* moderate\u002Fsevere intellectual disability,\n* inability to speak and write in Italian.\n\nInformal caregivers of patients inclusion criteria:\n\n* over 18 years old,\n* willing to participate, exclusion criteria:\n* inability to speak and write in Italian.\n\nMental health professionals inclusion criteria:\n\n* working in SRPs of the recruiting centers as a psychiatrist, educator, nurse, social worker, OSS, ASA, or TeRP,\n* if part of the \"personal recovery-oriented treatment\" group, having specific training, exclusion criteria:\n* unwillingness to participate.",true,{"count":135,"type":21},72,[24],"The project focuses on patients with severe mental disorders (SMD) residing in Italian mental health supported accommodation (SA). Although the goal of SA is to promote personal recovery - that is, living life to the fullest of one's potential - international literature on this topic is scarce, and traditional treatments in the Italian residential system show limitations in adopting such approaches.\n\nThe research hypothesis is that activating personal recovery pathways could improve the biopsychosocial outcomes of patients, caregivers, and professionals. To test this hypothesis, a non-pharmacological, non-randomized interventional trial will compare two groups: one group of individuals with SMD receiving recovery-oriented treatment, using the Mental Health Recovery Star, and another group of individuals with SMD receiving standard treatment.\n\nThe Mental Health Recovery Star is a ten-pointed star-shaped tool that represents various life dimensions. Patients, together with their key professional, are expected to negotiate a score for each domain on the five-stage 'Scale of Change,' capturing and monitoring the different phases of the recovery process.",[139,140],"Severe Mental Disorder","Severe Mental Illness",[142,143,144,145,146],"mental health supported accommodation","personal recovery","severe mental disorder","bio-psychosocial","rehabilitation","2025-12-11",{"date":149,"type":33},"2025-12-18",{"date":151,"type":21},"2026-01-15",{"date":153,"type":21},"2028-12-31",{"name":39,"class":40},3,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":163,"maxAge":79,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":173,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":41},"100592177","implementation-of-a-multiple-intervention-to-promote-healthy-lifestyles-in-patients-with-depression-100592177","NCT06990035","Implementation of a Multiple Intervention to Promote Healthy Lifestyles in Patients With Depression","Implementazione di un Intervento Multiplo Per Promuovere Stili di Vita Sani in Pazienti Con Depressione: Uno Studio Clinico Controllato e Randomizzato","Inclusion Criteria:\n\n* Primary diagnosis of depression (DSM-5 criteria, American Psychiatric Association 2013).\n* Depressive symptoms assessed using MADR, BDI, or ZDR scales.\n* Ability to provide written informed consent.\n* Self-reported moderate-intensity leisure physical activity of less than 150 minutes per week.\n\nExclusion Criteria:\n\n* Patients with severe psychopathology.\n* Medical contraindications to physical activity.\n* Orthopedic problems or other conditions limiting physical fitness assessment or currently pregnant.\n* Patients who underwent antibiotic\u002Fanti-inflammatory treatments in the last 3 months\n* Active gastrointestinal diseases\n* Autoimmune and\u002For chronic inflammatory disorders","55 Years",{"count":81,"type":21},[24],"This clinical trial aims to investigate whether an integrative approach combining education on the Mediterranean diet and physical activity (PA) can significantly reduce depressive symptomatology in individuals with major depressive disorder. The study will evaluate changes in depressive symptoms and assess biological modulations, including alterations in the gut microbiota and inflammatory markers, resulting from the PA intervention.\n\nParticipants will be randomized into two arms: the active control group will attend a series of lessons focused on the Mediterranean diet, while the experimental group will participate in the same dietary lessons combined with a structured PA program of 12 weeks.",[85],[169,170,171,172],"Major depressive disorder","Physical activity","Mediterranean Diet","Microbiome","NOT_YET_RECRUITING","2025-05-19",{"date":176,"type":33},"2025-05-25",{"date":178,"type":21},"2025-07",{"date":180,"type":21},"2026-02",{"name":39,"class":40},{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":111,"maxAge":51,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":155},"100566599","early-cogn3---smart-digital-solutions-for-early-treatment-of-cognitive-disability-a-neuropsychological-neurophysiological-and-neurobiological-perspective-in-chronic-neurological-diseases---pnrr-mcnt2-2023-12377069-100566599","NCT06657274","EARLY-COGN^3 - Smart Digital Solutions for EARLY Treatment of COGnitive Disability: a Neuropsychological, Neurophysiological and Neurobiological Perspective in Chronic Neurological Diseases - PNRR-MCNT2-2023-12377069","EARLY-COGN^3","Inclusion Criteria:\n\n* Diagnosis of PD (Hoehn \\& Yahr\\\u003C3); MCI (with CDR scale≤0.5, MMSE ≥24), and SCC (Subjective Cognitive Complaints);\n* Montreal Cognitive Assessment (MoCA) corrected score ≥17.36\n* Education ≥ 5 years\n* Age eligible for the study: 18≤age≤85\n* Native Italian speakers\n* Absence of marked hearing\u002Fvisual impairment\n* All of the subjects will have normal or corrected-to-normal vision.\n* Agreement to participate by signing the informed consent form\n* Availability of a caregiver\u002Fstudy partner able to support the participant\n* No rehabilitation program in place at the time of enrolment or in the last 3 months before enrolment\n* Stable drug treatment (last 3 months), if any\n\nExclusion Criteria:\n\n* Presence of any medical or psychiatric illness that could interfere with completing assessments;\n* Presence of any medical condition representing a contraindication to TMS.",{"count":190,"type":21},60,[24],"The increase in life expectancy in recent decades has led to a large number of people living into old age and an increased risk of developing Chronic Neurological Diseases (CNDs) such as neurodegenerative diseases. A higher cumulative risk of dementia has been largely demonstrated in Mild Cognitive Impairment (MCI) and Subjective Cognitive Complaints (SCCs) subjects and in Parkinson's Disease (PD) patients, as compared to the general population. These disorders result in an impairment of the individual's abilities to perform daily tasks. As their disease progresses, patients become dependent on medical services and on family support. Given the limited effectiveness of pharmacological treatments, non-pharmacological interventions to prevent and treat cognitive deficits and the associated difficulties with activities of daily living in neurodegenerative disease patients have gained attention in recent years and, among these, cognitive training offers a potential approach for dementia prevention and improvement of cognitive function. A critical aspect of cognitive training programs is that the most promising interventions have involved intensive in-person sessions that are unlikely to be cost-effective or feasible for large-scale implementation. Within the framework of non-pharmacological interventions, the use of technology to assist the person at risk and\u002For with mild dementia at home and to extend rehabilitation services in the treatment of dementia has gradually gained importance. Telerehabilitation technologies allow to provide services remotely in patients' homes, allowing access to health care to patients living in rural settings or with mobility difficulties. In addition, the telerehabilitation modality offers the advantage of providing rehabilitation within the natural environment of the patient's home, making the treatment more realistic and possibly more generalizable to the person's daily life. The present project proposes to test a home-based asynchronous cognitive telerehabilitation program aimed at enhancing the continuum of care for MCI, SCCs and PD, using technology. The proposed study is a single blind randomized controlled trial (RCT) involving subjects with CNDs randomly assigned to one out of two intervention groups: i) the tele@cognitive group, who will receive at-home cognitive telerehabilitation (tele@cognitive treatment); ii) the Active Control Group (ACG), who will receive at-home unstructured cognitive stimulation. The aim of the project will be threefold: \\[1\\] to test the short-term and long-term efficacy of tele@cognitive protocol as compared to an unstructured cognitive at-home rehabilitation in the treatment of a cohort of patients with CNDs; \\[2\\] to explore the changes induced by tele@cognitive intervention on biomolecular and neurophysiological markers; \\[3\\] to explore potential cognitive, neurobiological and neurophysiological predictors of response to tele@cognitive treatment.",[194,195,196],"Mild Cognitive Impairment (MCI)","Subjective Cognitive Complaints (SCCs)","Parkinson Disease","2025-04-30",{"date":199,"type":33},"2025-05-02",{"date":201,"type":33},"2024-12-09",{"date":203,"type":21},"2026-08-30",{"name":39,"class":40},{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":133,"sex":17,"minAge":111,"maxAge":78,"enrollmentInfo":211,"targetDuration":4,"studyType":213,"phases":4,"briefSummary":214,"conditions":215,"keywords":217,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":41},"100584254","an-integrated-neurophysiological-approach-toward-the-early-detection-of-psychiatric-disorders-100584254","NCT06886945","An Integrated Neurophysiological Approach Toward the Early Detection of Psychiatric Disorders","Inclusion Criteria (all participants):\n\n* Normal hearing\n* Normal or corrected-to-normal vision\n\nInclusion Criteria (patients):\n\n* Clinical diagnosis of schizophrenia spectrum disorder (according to DSM-5)\n* IQ \\> 70\n\nExclusion Criteria (all participants):\n\n* Anamnesis or evidence of any central nervous system alteration\n\nExclusion Criteria (patients)\n\n* Current major physical illness\n* Drug dependency\u002Fabuse over the last 6 months\n* Unstable pharmacological therapy\n* Comorbidities with other major psychiatric disorders",{"count":212,"type":21},75,"OBSERVATIONAL","Schizophrenia (SCZ) is a severe neuropsychiatric disorder characterized by cognitive decline, social withdrawal, and positive symptoms such as hallucinations and delusions. Research suggests that SCZ and schizotypy exist along a continuum, with shared structural and behavioral abnormalities, the latter of which encompass the sensory and perceptual domain, often in the form of altered multisensory integration, as seen in tasks like the Sound-Induced Flash Illusion (SIFI). Individuals with schizotypal traits or SCZ show enlarged temporal binding windows (TBW) of cross-modal integration, affecting perceptual accuracy and multisensory judgments. However, whether these deficits stem from overactive top-down modulation or weakened bottom-up sensory precision remains unclear.\n\nThe current study seeks to address these questions, by asking participants (healthy individuals screened as for their schizotypal traits, and patients suffering from SCZ) to complete a modified version of the SIFI, as well as an audiovisual temporal order judgment (TOJ) task. Cross-modal performance will be assessed via signal detection theory (SDT) metrics and psychometric modeling to estimate individual TBWs, thereby assaying audiovisual processing abilities along the schizotypal continuum",[216],"Schizophrenia Disorders",[218,219,220,221,222],"Schizophrenia","Audio-Visual Integration","Temporal Binding Windows","Signal Detection Theory","Schizotypal Personality","2025-03-14",{"date":225,"type":33},"2025-03-20",{"date":227,"type":33},"2024-04-09",{"date":229,"type":21},"2025-10",{"name":39,"class":40},{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":243,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":252,"locationsCount":253},"100495349","a-multimodal-approach-for-clinical-diagnosis-and-treatment-of-primary-progressive-aphasia-mainstream-id3430931-100495349","NCT05730023","A Multimodal Approach for Clinical Diagnosis and Treatment of Primary Progressive Aphasia, MAINSTREAM ID:3430931","MAINSTREAM","Inclusion Criteria:\n\n* Diagnosis PPA according to the current clinical criteria (Gorno-Tempini et al., 2011);\n* Mild PPA defined using the Progressive Aphasia Severity Scale (PASS);\n* Italian native speakers.\n\nExclusion Criteria:\n\n* Presence of developmental disorders;\n* Presence of any medical or psychiatric illness that could interfere in completing assessments;\n* Presence of any medical condition that represents a contraindication to tDCS.",{"count":190,"type":21},[24],"Primary Progressive Aphasia (PPA) is a syndrome due to different neurodegenerative disorders selectively disrupting language functions. PPA specialist care is underdeveloped. There are very few specialists (neurologists, psychiatrists, neuropsychologists and speech therapists) and few hospitals- or community-based services dedicated to diagnosis and continuing care. Currently, healthcare systems struggle to provide adequate coverage of diagnostic services, and care is too often fragmented, uncoordinated, and unresponsive to the needs of people with PPA and their families. Recently attention has been gained by digital-health technologies, such immunoassay analyzer and high-field MRI, the most promising approaches to increase our understanding of neurodegeneration, and by new non-invasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) that allow a personalized treatment approach. Our goal is to develop a new treatment approach in PPA in which the regional secondary care centers participating in this project should be the hub of a regional network. The MAINSTREAM (WP2- Efficacy of personalized training in the early stage of PPA) looks forward to introduce and evaluate therapeutic innovation such as tDCS coupled with language therapy in rehabilitation settings (WP2 Early Treatment).\n\nThis objective will be pursued by conducting a randomized controlled pilot study in order to evaluate the efficacy of a combined treatment of Active (anodal) tDCS and individualized language training compared to Placebo tDCS combined with individualized language training in a subgroup of mild PPA defined using the Progressive Aphasia Severity Scale (PASS) (Sapolsky D, Domoto-Reilly K, Dickerson BCJA. Use of the Progressive Aphasia Severity Scale (PASS) in Monitoring Speech and Language Status in PPA. (2014) 28(8-9):993-1003).",[242],"Primary Progressive Aphasia",[244,245],"Behavioral and neural effects of tDCS combined with language training","Alzheimer's disease and other dementias","2024-09-06",{"date":248,"type":33},"2024-09-19",{"date":250,"type":33},"2023-02-01",{"date":180,"type":21},{"name":39,"class":40},4,{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":262,"minAge":111,"maxAge":18,"enrollmentInfo":263,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":268,"overallStatus":173,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":41},"100551516","physical-activity-in-people-with-borderline-personality-disorder-pabord-100551516","NCT06461104","Physical Activity in People With Borderline Personality Disorder (PABORD)","Physical Activity in People With Borderline Personality Disorder (PABORD): a Study Protocol for a Pilot Randomised Controlled Trial (RCT)","PABORD","Inclusion Criteria:\n\n* Female gender.\n* Age between 18 and 40 years.\n* Primary diagnosis of Borderline Personality Disorder (BPD) according to the diagnostic criteria of the DSM-5.\n* Outpatient treatment.\n* Ability to provide written informed consent.\n* Good understanding of the Italian language.\n* Proficiency in using a smartphone.\n* The presence of ongoing pharmacological and\u002For psychotherapeutic treatments is not considered an exclusion criterion.\n\nExclusion Criteria:\n\n* Current pregnancy or planning a pregnancy within the next 6 months.\n* Acute psychotic symptoms.\n* Comorbidities with Eating Disorders, Substance Use Disorder, and Bipolar Disorder.\n* Absolute contraindications to physical exercise, such as medical conditions that interfere with the ability to perform exercise or with the physiological response to exercise tests, e.g., the use of beta-adrenergic blocking agents.","FEMALE",{"count":190,"type":21},[24],"The aim of this Randomised Controlled Trial (RCT) is to test the effects of a structured physical activity (PA) program on symptoms in female outpatients aged 18 to 40 years with a diagnosis of Borderline Personality Disorder (BPD). The main questions it aims to answer are:\n\n1. Does a structured PA program reduce clinical symptoms in patients with BPD?\n2. How does the effectiveness of a structured PA program compare to a psychoeducational intervention in reducing clinical symptoms and improving physical activity parameters?\n\nParticipants will participate in a 12-week structured PA program preceded by three weekly psychoeducation sessions focused on nutrition (intervention group) or will receive a 12-week psychoeducational program on nutrition and PA (control group).\n\nResearchers will compare the intervention group (structured PA program) and the control group (psychoeducational program) to see if the structured PA program leads to greater improvements in clinical symptoms and physical activity parameters. Moreover, the study includes a multidimensional assessment (physical, psychological, and biological) at four time points: at the start of the treatment (T0), at 6 weeks (mid-treatment, when changes from PA become visible and measurable), at the end of the 3-month treatment period (T3), and at a 3-month follow-up after the treatment (T6).",[267],"Borderline Personality Disorder",[86,267,269,270,271,272,273,274,275],"ESM","Females","Global Functioning","Accelerometer","Motivation","Premenstrual Syndrome","Outpatients","2024-06-11",{"date":278,"type":33},"2024-06-14",{"date":280,"type":21},"2024-09-01",{"date":282,"type":21},"2025-04-01",{"name":39,"class":40},""]