[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"IRCCS National Neurological Institute \\\"C. Mondino\\\" Foundation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":405},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,45,74,98,128,159,187,209,232,258,286,309,324,355,375],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100644279","phrenic-nerve-and-diaphragm-electrophysiology-in-pompe-disease-100644279",false,"NCT07664930","Phrenic Nerve and Diaphragm Electrophysiology in Pompe Disease","Electrophysiological Study of the Phrenic Nerve and Diaphragm in Pompe Disease: Retrospective and Prospective Cohort Analysis","Inclusion Criteria:\n\nAge ≥ 18 years.\n\nFor the prospective cohort:\n\n* Genetically confirmed diagnosis of Pompe disease.\n* Ability to undergo routine neurophysiological and respiratory assessments.\n* Written informed consent provided.\n\nFor the retrospective cohort:\n\n* History of restrictive respiratory failure or unexplained hypoventilation.\n* Availability of previous phrenic nerve conduction studies and\u002For diaphragm electromyography performed as part of routine clinical evaluation.\n\nExclusion Criteria:\n\n\\- Age \\\u003C 18 years.\n\nFor the prospective cohort:\n\n* Conditions preventing completion of neurophysiological assessments (e.g., inability to maintain required positioning or relevant clinical contraindications).\n* Known primary phrenic nerve injury (e.g., postsurgical phrenic palsy or documented traumatic phrenic neuropathy).\n* Presence of other neuromuscular disorders potentially confounding data interpretation.\n* Refusal or inability to provide informed consent.\n\nFor the retrospective cohort:\n\n* Incomplete or technically non-interpretable neurophysiological examinations.\n* Previously established respiratory or neuromuscular diagnoses fully explaining respiratory impairment.\n* Cases requiring additional clinical information for study purposes when patient consent for contact or data completion cannot be obtained.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","OBSERVATIONAL","Pompe disease is traditionally considered a lysosomal myopathy. However, increasing experimental and clinical evidence suggests involvement of the entire motor unit, including motor neurons, peripheral nerves, neuromuscular junctions, and skeletal muscle. Respiratory impairment is a major cause of morbidity and mortality, and diaphragm dysfunction is frequently observed.\n\nClinical observations at IRCCS Fondazione Mondino have highlighted neurophysiological abnormalities of the phrenic nerve and diaphragm in patients with Pompe disease and respiratory involvement, sometimes occurring even in the absence of clinically significant limb muscle weakness. These findings suggest that respiratory motor unit dysfunction may represent an important component of the disease phenotype.\n\nThis observational study aims to systematically characterize phrenic nerve conduction parameters and diaphragm electromyographic findings in adult patients with genetically confirmed Pompe disease and in patients with unexplained respiratory failure. Retrospective and prospective clinical, neurophysiological, and respiratory data collected during routine clinical care will be analyzed to explore whether phrenic nerve and diaphragm abnormalities may serve as markers of respiratory motor unit involvement in Pompe disease.",[24],"Pompe Disease",[26,27,28,29,30,31],"Pompe disease","Phrenic nerve","Diaphragm","Respiratory muscle weakness","Neuromuscular respiratory failure","Motor unit","RECRUITING","2026-06-17",{"date":35,"type":36},"2026-06-24","ACTUAL",{"date":38,"type":36},"2026-03-30",{"date":40,"type":20},"2029-02-28",{"name":42,"class":43},"IRCCS National Neurological Institute \"C. Mondino\" Foundation","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":44},"100593737","integrating-ai-in-postural-rehabilitation-for-parkinsons-disease-100593737","NCT07010328","Integrating AI in Postural Rehabilitation for Parkinson's Disease","Efficacy of Integrating Artificial Intelligence Solutions in Rehabilitation in Postural Trunk Disorders in Parkinson's Disease.","Inclusion Criteria:\n\n* Age above 18 years\n* Diagnosis of Parkinson's disease according to MDS criteria\n* Hoehn and Yahr stage ≤ III\n* Clinical diagnosis of camptocormia (presence of an anterior axial trunk flexion of at least 30°), or of Pisa Syndrome (presence of a lateral trunk flexion of at least 10°) at the time of enrollment (T0)\n* Mini-Mental State Examination (MMSE) score \\> 23\n\nExclusion Criteria:\n\n* Atypical parkinsonian syndromes\n* History of spinal surgery\n* Previous vertebral trauma\n* Current or past spinal tumors or infections\n* Idiopathic scoliosis\n* Ankylosing spondylitis\n* Spinal canal stenosis\n* Other neurological conditions\n* Severe dyskinesias",{"count":19,"type":20},"INTERVENTIONAL",[55],"NA","Postural abnormalities are highly disabling complications of Parkinson's disease (PD). These include camptocormia, anterocollis, and Pisa Syndrome (PS). PS is characterized by a lateral trunk flexion (LTF) typically exceeding 10 degrees, often accompanied by axial rotation, asymmetric shoulder positioning, and poor awareness of the postural alteration. This condition worsens during upright activities and improves in a supine position. Patients with PD and PS are characterized by more pronounced motor asymmetry, a disorganized trunk muscle activity, back pain, balance issues, and reduced quality of life compared to PD patients without postural disorders.\n\nCamptocormia, another disabling postural anomaly, involves an anterior trunk flexion that also improves when lying down. Both PS and camptocormia are challenging to treat, with limited and short-lasting benefits from current multidisciplinary approaches, including medication, physiotherapy, botulinum toxin injections, and transcranial direct current stimulation (tDCS).\n\nGiven the limitations of traditional rehabilitation strategies, there is a growing need for innovative and personalized approaches. In this context, advanced technologies such as artificial intelligence (AI) offer new possibilities for home-based treatment. This study aims to evaluate the feasibility of using a real-time visual feedback system powered by AI as a complementary intervention following inpatient neurorehabilitation for PD patients with trunk postural disorders (PS or camptocormia). A secondary objective is to assess whether an AI-guided, personalized exercise program can help maintain improvements in posture, mobility, and quality of life in the medium term.\n\nBy integrating quantitative and qualitative outcomes, this study seeks to fill a gap in the literature and explore the potential of AI-driven home rehabilitation to support long-term functional gains and foster greater independence and well-being in people with PD.",[58,59,60,61],"Parkinson Disease","Physical Inactivity","Physical Disability","Pisa Syndrome",[63,64,65],"Physical activity","Neurological disorder","Artificial Intelligence","2025-05-29",{"date":68,"type":36},"2025-06-08",{"date":70,"type":36},"2024-10-01",{"date":72,"type":20},"2028-12",{"name":42,"class":43},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":44},"100591190","physical-activity-on-neuroinflammation-in-parkinsons-disease-100591190","NCT06977204","Physical Activity on Neuroinflammation in Parkinson's Disease","Role of Physical Activity on Neuroinflammation in Parkinson's Disease","MOVE-ON_WP1","Inclusion Criteria:\n\n* Subjects of both sexes, aged between 40 and 80 years (extremes included)\n* Diagnosis of Parkinson's disease according to the clinical diagnostic criteria of the Movement Disorder Society\n* Hoehn \\& Yahr between 1 and 3\n\nExclusion Criteria:\n\n* Concomitant diagnosis of other neurological diseases\n* Presence of confirmed cognitive decline (MMSE \\\u003C 24)\n* Presence of depression with (BDI \\> 40)\n* Patients with deep brain stimulation implant or undergoing DuoDopa therapy\n* Presence of significant diseases affecting the musculoskeletal system\n* Presence of internal medicine conditions, considered clinically significant by the investigator\n* Acute or recent infections\n* Body Mass Index (BMI) \\>= 30\n* Active smoking behavior\n* Ongoing treatment with N-acetylcysteine or anti-oxidants\n* Pregnancy or lactation","40 Years","80 Years",{"count":85,"type":20},40,"Parkinson's Disease (PD) is a chronic progressive neurodegenerative disorder clinically defined by the association of resting tremor, rigidity, bradykinesia, and postural instability. The histopathology of PD is characterized by the loss of neurons in the substantia nigra pars compacta (SNPc) and the accumulation of α-synuclein aggregates within Lewy bodies. The pathogenic mechanisms underlying the development of the disease, however, are not yet fully understood: genetics, cellular oxidative stress, mitochondrial dysfunction, environmental factors, and neuroinflammation are all potential mechanisms involved in the pathogenesis of PD.\n\nSeveral studies have now established the involvement of neuroinflammation in the pathogenesis of PD. It is known that α-synuclein aggregates stimulate microglia and astroglia to secrete pro-inflammatory mediators such as IL 1β, IL6, and TNFα. These molecules activate an inflammatory response characterized by altered blood-brain barrier permeability, leukocyte recruitment, and the expression of other pro-inflammatory cytokines. These events contribute to exposing neurons to oxidative stress and cellular damage. Additionally, cellular damage induces neurons to stimulate the release of DAMPs (Damage Associated Molecular Patterns), which in turn activate glial cells. This creates a state of chronic inflammation that could play a role in the progression of the disease. Supporting this hypothesis, elevated levels of IL1β, IL6, and TNFα have been found in the striatum and SNPc of post-mortem PD samples.\n\nThe transcription factor Nrf2 is one of the main regulators of cellular protection in response to stress (inflammation, redox, xenobiotics). Nrf2 promotes the expression of several genes that cooperate in a cytoprotective response, which includes antioxidant defense, resolution of inflammation, increased mitochondrial activity, and protein turnover. Recent clinical studies seem to confirm the hypothesis that Nrf2 plays a role in the pathogenesis of PD, as already suggested by preclinical models. Specifically, altered plasma levels of the Nrf2-activated pathway have been observed in preclinical models.\n\nStudies conducted on animal models of PD have hypothesized how exercise might correlate with protective mechanisms and might promote neuroplasticity and neuro-regeneration, especially when practiced at high intensity. Physical exercise can indeed modulate various systems (including inflammatory pathways and oxidative stress) that regulate neuroinflammation and glial activation. However, the available results are not definitive and often focus on single and separate aspects of the disease.\n\nThe aim of the study is to investigate the beneficial effect of physical exercise in patients with Parkinson's Disease (PD). Literature already suggests an improvement in various domains of motor and non-motor aspects, as well as in the overall quality of life, of PD patients even after a period of aerobic activity. Generally, training periods included 3-4 sessions per week of 40-60 minutes each for 4-16 weeks. In general, the literature describes the effects of moderate physical training, while little or nothing is known about how PD is affected by high-intensity sports training.\n\nThe primary objective of our study is to compare a group of PD patients undergoing regular and constant intense exercise (PD-sport) with a control group consisting of PD patients leading a sedentary life (PD-sedentary). The primary outcome will be the difference in systemic inflammatory status between the PD-sport group and the PD-sedentary group.",[58,59,60],[63,64,89],"Neuroinflammation","2025-05-14",{"date":92,"type":36},"2025-05-18",{"date":94,"type":36},"2023-01-01",{"date":96,"type":20},"2026-06-01",{"name":42,"class":43},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":53,"phases":108,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":44},"100591645","case-finding-for-neurocognitive-disorders-in-pavia-100591645","NCT06983119","Case-Finding for Neurocognitive Disorders in Pavia","OPENING OF A MEMORY CLINIC IN THE PROVINCE OF PAVIA: Evaluation of Case-finding Strategies and Care for People With Cognitive Decline and Their Caregivers.","C-FiND Pavia","For the Primary Outcome the inclusion criteria are:\n\n* Age 50 or older\n* Assessment conducted using GPcog\u002FACE-III depending on the setting\n* No prior diagnosis of cognitive decline\n* Ability to understand the study objectives and sign an informed consent\n\nFor the Primary Outcome the exclusion criteria are:\n\n* Age under 50\n* Presence of a diagnosis of cognitive decline\n* Limited knowledge of the Italian language\n\nFor the secondary outcome the inclusion criteria are:\n\nPatient:\n\n* All patients\u002Fpeople who are included in one of the actions provided through the \"Ricor-Dare\" Project or who are attending a visit scheduled in the clinical-care pathway of the CDCD Fondazione Mondino Pavia or Lomellina;\n* Ability to understand the aims of the study and to sign an informed consent\n\nCaregiver:\n\n* Age equal to or greater than 18 years\n* Informal caregiver of a family member with a suspected or confirmed diagnosis of dementia who is included in one of the actions provided through the \"Ricor-Dare\" project or who are attending a visit scheduled in the clinical-care pathway of the CDCD;\n* Acceptance of informed consent and voluntary participation in the study.\n\nHealthcare professionals:\n\n* All healthcare and social healthcare professionals (GPs, pharmacists, nurses, nurses auxiliary) who practice in the cities of Pavia and Vigevano who participate in the project and agree to undergo assessments and training;\n* Acceptance of informed consent and voluntary participation in the study.\n\nFo the Secondary Outcome the exclusion criteria are:\n\nPatient:\n\n\\- Inability to understand the aims of the study and to sign an informed consent\n\nCaregiver:\n\n* Age under 18\n* Formal caregivers, i.e. any person who provides assistance to the patient in exchange for payment of a fee;\n* Caregivers with limited knowledge of the Italian language.",{"count":107,"type":20},490,[55],"Dementia is a global public health challenge with a heavy caregiving burden, impacting families, communities, and healthcare systems. It is a priority in healthcare planning, with focus on early diagnosis and ongoing support. This research project addresses the global public health challenge posed by dementia, focusing on early detection and comprehensive care. The research evaluates the clinical, social, and healthcare impact of two dementia-related projects in Italy:\n\n1. the first \"Ricor-Dare,\" aims to create an integrated network for identifying new cases of dementia or Mild Cognitive Impairment (MCI) and providing care to patients and caregivers;\n2. the second involves establishing a new Center for Cognitive Disorders and Dementia (CCDD) in an area previously lacking such services.\n\nThe primary goal of this study is to assess the effectiveness of case-finding strategies promoted by the \"Ricor-Dare\" project for the early detection of cognitive decline. Researchers will compare three different settings in which case-finding will be conducted: at the general practitioners' offices, at the Dementia Operations Center, and at Open Days for the general population. The aim is to measure how many individuals in these three settings are diagnosed with Mild Cognitive Impairment (MCI) or dementia, compared to those identified as potential cases through cognitive testing.\n\nThe secondary goal of the study is to assess the social, care, and prevention impact of the activities offered within the two projects. This includes evaluating the experiences of patients and families who access the new CCDD in the province of Pavia, the impact of care pathways on caregivers, and comparing the effectiveness of the new CCDD with existing ones in the region of Lombardia. The study will also assess the role of the \"Ricor-Dare\" project in addressing the needs of patients, caregivers, and professionals, as well as the effectiveness of awareness-raising and training activities on dementia. Overall, the study aims to provide valuable insights into improving care for people with dementia and supporting their families and caregivers.",[111,112],"Dementia","Mild Cognitive Impairment",[114,111,112,115,116,117,118,119],"Case-finding","Memory Clinic","Center for Cognitive Disorders and Dementia","Non-pharmacological intervention","Caregiver","Burden","2025-05-13",{"date":122,"type":36},"2025-05-21",{"date":124,"type":36},"2024-07-11",{"date":126,"type":20},"2026-07-31",{"name":42,"class":43},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":44},"100583883","neurophysiological-and-biomolecular-effects-of-atogepant-in-episodic-migraine-100583883","NCT06882122","Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine","Neurophysiological and Biomolecular Effects of Atogepant in High Frequency Episodic Migraine (ATOM Project)","ATOM","Inclusion Criteria:\n\n* Individuals aged between 18 and 70;\n* Diagnosis of episodic migraine according to ICHD-3 criteria;\n* Monthly migraine days between 8 and 14 (high-frequency episodic migraine pattern) in the 3 months before screening;\n* Individuals naïve to CGRP-targeted treatments;\n* No more than one ongoing migraine preventive treatment with a stable dose for at least 3 months.\n\nExclusion Criteria:\n\n* Contraindications to atogepant;\n* History of serious psychiatric conditions;\n* Diagnosis of other primary or secondary headaches (only sporadic tension-type headache is allowed);\n* Medical conditions considered clinically significant by the investigator;\n* Chronic pain conditions that need chronic treatment;\n* Abuse of alcohol and\u002For drugs;\n* Pregnancy or breastfeeding.","70 Years",{"count":138,"type":20},30,"The investigators aim to assess and compare neurophysiological and biochemical changes induced by a 3-month treatment with atogepant (60 mg daily) in patients with high-frequency episodic migraine (8-14 monthly migraine days). Evaluations will include neurophysiological assessments (High-Density EEG, nociceptive reflexes, and visual evoked potentials) and biomolecular profiling (gene expression of endocannabinoid catabolizing enzymes, CGRP and PACAP plasma levels, and headache-specific microRNAs). Outputs will contribute to defining predictors of atogepant response, elucidating its effects on brain connectivity, excitability, and CGRP\u002Fendocannabinoid pathways, and identifying alternative therapeutic targets for non-responders.",[141,142],"Migraine Disorder","Episodic Migraine",[144,145,146,147,148,149,150],"Migraine","Gepants","endocannabinoid system","MicroRNAs","Habituation deficit","Central sensitization","Functional Connectivity","2025-03-11",{"date":153,"type":36},"2025-03-18",{"date":155,"type":36},"2024-12-01",{"date":157,"type":20},"2026-04",{"name":42,"class":43},{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":166,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":53,"phases":170,"briefSummary":171,"conditions":172,"keywords":175,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":44},"100578616","effect-of-cognitive-behavioral-play-intervention-and-epilepsy-100578616","NCT06813612","Effect of Cognitive Behavioral Play Intervention and Epilepsy","The Effects of Cognitive Behavioral Play Intervention on the Quality of Life of Children With Childhood-onset Epileptic Syndromes.\"","For the purposes of the study, children aged between 6 and 10 years, of both sexes, will be recruited.\n\n\\- inclusion criteria Children diagnosed with the following types of epilepsy will be included: childhood self-limiting focal epilepsy (SeLFE); childhood absence epilepsy (CAE); self-limiting centrotemporal paroxysmal epilepsy (SeLECTS); self-limiting epilepsy with autonomic seizures (SeLEAS); childhood occipital epilepsy (COVE); photosensitive occipital lobe epilepsy (POLE).\n\nExclusion criteria:\n\n* Children with epilepsy in comorbidity with cognitive disabilities (the relevant cognitive disabilities must be specified with IQ scores)\n* reduced visual or expressive hearing acuity (visually impaired or deaf) will be excluded.","6 Years","10 Years",{"count":169,"type":20},52,[55],"The goal of this clinical trial is to assess the effectiveness of Cognitive Behavioral Play Therapy interventions in patients with epilepsy.\n\nChildren with epilepsy will be randomly assigned to one of two intervention conditions: the experimental group will receive cognitive-behavioral play intervention, while the control group will engage in free play. Assessments will be done at the start (T0) and end (T1) of the intervention, measuring behaviors, coping strategies, positive thinking, problem-solving, and quality of life.",[173,174],"Epilepsy","Epilepsy in Children",[176,177,178],"epilepsy","psychology","cognitive behavioral play therapy","2025-02-03",{"date":181,"type":36},"2025-02-07",{"date":183,"type":36},"2024-10-07",{"date":185,"type":20},"2026-10",{"name":42,"class":43},{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":194,"maxAge":17,"enrollmentInfo":195,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":197,"conditions":198,"keywords":199,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":44},"100575937","transition-from-pediatric-to-adult-epilepsy-care-100575937","NCT06778772","Transition From Pediatric to Adult Epilepsy Care","Transition to Adult Care in Epilepsy","\\*\\*Inclusion Criteria:\\*\\*\n\n* Patients aged 17 or 18 years.\n* Diagnosed with focal or generalized epilepsy, regardless of etiology and neuropsychological, neuropsychiatric, or internal comorbidities.\n* Those for whom continued epileptology follow-up is required according to standard care guidelines.\n\n\\*\\*Exclusion Criteria:\\*\\*\n\n* Patients undergoing EEG only for the detection of EEG abnormalities without a diagnosis of epilepsy.\n* Patients for whom the last neuropsychiatric evaluation does not recommend continued epileptology follow-up (patients considered \"cured\" from epilepsy according to ILAE guidelines).","17 Years",{"count":196,"type":20},90,"The goal of this observational study is to assess the preparation of the caregiver and the patient for the transition, by comparing the results of the Transition Readiness Assessment (TRAQ) questionnaire at the time of the last pediatric neuropsychiatric visit, which is then repeated at the first adult epilepsy neurology visit.\n\nThe assessments will be conducted at the last evaluation at the pediatric epilepsy service and repeated at the first visit to the adult epilepsy service.",[173],[176,200],"transition","2025-01-14",{"date":203,"type":36},"2025-01-16",{"date":205,"type":36},"2023-06-01",{"date":207,"type":20},"2025-06-01",{"name":42,"class":43},{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":216,"maxAge":194,"enrollmentInfo":217,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":229,"leadSponsor":231,"locationsCount":44},"100576190","idiopathic-generalized-epilepsy-cognitive-and-emotional-profile-100576190","NCT06782074","Idiopathic Generalized Epilepsy Cognitive and Emotional Profile","Idiopathic Generalized Epilepsy: Cognitive, Emotional, Behavioral Functioning, and Quality of Life","Inclusion criteria:\n\nAge between 11 and 18 years Diagnosis of idiopathic generalized epilepsy\n\nExclusion criteria:\n\nAge under 11 years or over 18 years Structural or cryptogenic epilepsy Intellectual disability or borderline cognitive level Refusal to participate in the study Failure to obtain informed consent","11 Years",{"count":218,"type":20},96,"The primary goal of the study is to explore the neurocognitive, emotional-behavioral functioning, and quality of life of adolescents with IGE, identifying key factors that affect their overall well-being.\n\nThe study involves participants and their caregivers completing standardized questionnaires. Additionally, clinical and anamnesic information will be collected to investigate the role of these variables on the emotional and executive functioning of the enrolled subjects",[173,221,222,223,224],"Quality of Life","Neuropathology","Emotional Problem","Executive Dysfunction","2025-01-13",{"date":227,"type":36},"2025-01-17",{"date":205,"type":36},{"date":230,"type":20},"2025-06-30",{"name":42,"class":43},{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":239,"enrollmentInfo":240,"targetDuration":4,"studyType":53,"phases":242,"briefSummary":243,"conditions":244,"keywords":246,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":44},"100571068","multiple-sclerosis-and-the-effects-of-ketogenic-diet-therapy-100571068","NCT06715436","Multiple Sclerosis and the Effects of Ketogenic Diet Therapy","The Effects of Ketogenic Diet Therapy Versus the Mediterranean Diet on Quality of Life in a Group of Patients With Multiple Sclerosis - the KETOMED-MS Study","Inclusion Criteria:\n\n* Diagnosis of relapsing-remitting MS (RRMS) or progressive MS (PMS)\n* Age between 18 and 60 years\n* BMI between 18.5 kg\u002Fm2 and 39.9 kg\u002Fm2\n* If on disease-modifying drugs, stable for 6 months, or no use of drugs in the previous 6 months\n* Ability to give verbal and written consent\n\nExclusion Criteria:\n\n* Patients actively engaged in a weight loss program or other specific diet (e.g. vegetarian, vegan); patients not willing to follow the assigned dietary pattern or patients with high adherence to MedDiet (MediLite score \\> 14)\n* Pregnancy or breastfeeding\n* Relapse or cortisone treatment within 30 days before study entry\n* Clinically relevant metabolic, progressive or malignant diseases\n* Intake of \\> 1 g\u002Fday of omega-3 fatty acid supplements\n* Underweight (BMI\\\u003C18.5 kg\u002Fm2) or severe obesity\n* Significant cognitive-cooperative impairment\n* Insulin-dependent diabetes mellitus (type I)\n* Weight loss greater than 5 kg within 2 months prior to study entry\n* Diagnosis or suspicion of an eating disorder\n* Kidney stones\n* Oral anticoagulant therapy\n* Known alcohol and drug abuse\n\nTelephonic interviews will be performed monthly to evaluate adherence to the dietary treatment and\u002For whether any changes in supplements use, physical activity, nutrition habits.","60 Years",{"count":241,"type":20},111,[55],"Multiple sclerosis (MS) is an inflammatory and immune-mediated neurological disease with multifactorial etiology. The specific etiopathogenetic mechanisms of MS are still unknown but it is clear that it results from a combination of genetic and environmental factors. Several studies have reported the possible role of diet as a risk factor for MS and its progression. To date, many dietary patterns and their association with MS have been studied, but data is still limited and inconclusive. Mediterranean Diet (MedDiet) has been associated with a lower risk of developing MS, compared to a Western-style diet. In one of investigators' studies, higher MedDiet adherence was associated with a 6-fold greater likelihood of having lower disease severity than those with low adherence. A significant restriction of carbohydrates (up to ketogenesis) can have beneficial effects on various parameters (inflammatory markers, oxidative stress, altered glucose metabolism) which are altered in subjects with MS. Ketogenic diet therapies (KDTs) have been recommended mainly for children with drug-resistant epilepsy, but in recent years they have been applied to Multiple Sclerosis. Preclinical studies in animal models evaluating the efficacy of KDTs in experimental autoimmune encephalomyelitis (EAE) found a beneficial effect of diet in slowing of disease progression, improvement of motor disability, reduction of inflammatory cytokines and reactive oxygen species. In a randomized study, improvements in health-related quality of life (HRQL) scores and a slight decrease in EDSS scores were found. An open-label, single-arm study of 20 patients with RRMS also reported that, after 6 months of MAD, no subjects had new or enlarging FLAIR\u002FT2 lesions, with a significant improvement in the EDSS score, the Modified Fatigue Impact Scale subscales and arm. A 3-arm parallel-arm randomized controlled pilot study was planned to determine the effectiveness of a modified Atkins diet (MAD) compared to a Mediterranean diet (MedDiet) on quality of life in a population with MS.",[245],"Multiple Sclerosis, Relapsing-Remitting",[247,248,249],"Multiple Sclerosis","Ketogenic Dietary Therapy","Mediterranean diet","2024-12-18",{"date":252,"type":36},"2024-12-20",{"date":254,"type":36},"2024-03-15",{"date":256,"type":20},"2025-09-15",{"name":42,"class":43},{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":266,"enrollmentInfo":267,"targetDuration":269,"studyType":21,"phases":4,"briefSummary":270,"conditions":271,"keywords":274,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":44},"100558296","biochemical-profiling-of-migraine-patients-100558296","NCT06549270","Biochemical Profiling of Migraine Patients","Unraveling the Spectrum of Migraine Resistant to Treatments: Searching for Novel Biological PHEnotypes and theRApeutic Approaches (SPHERA Project)","SPHERA_WP1_1","Inclusion Criteria:\n\n* male and female patients aged 18 to 75 years\n* diagnosis of episodic migraine or chronic migraine according to ICHD-3 criteria\n* for episodic migraine: 8-14 monthly migraine days in the previous 3 months\n* diagnosis of resistant migraine defined by: i) having failed at least 3 classes of migraine preventatives and ii) suffering from at least 8 debilitating monthly headache days for at least 3 consecutive months\n* patients naive to CGRP targeting treatments\n\nExclusion Criteria:\n\n* history of major psychiatric or other neurological conditions\n* diagnosis of other primary or secondary headache disorders (only sporadic tension-type headache is allowed if the patients can clearly differentiate between the 2 types of headaches)\n* changes in ongoing preventive treatment (if any) in the previous 3 months\n* clinically significant medical conditions\n* chronic pain conditions\n* alcohol and\u002For drug abuse\n* pregnancy or lactation","75 Years",{"count":268,"type":20},100,"3 Months","Aim of the study was to assess a potential dysfunction of the endocannabidiome system (eCBome) in migraine patients. Migraine patients who will undergo preventive therapy with monoclonal antibodies directed against the calcitonin gene related peptide (mAbs) will be evaluated through a deep phenotyping of peripheral neurochemical biomarkers (eCBome, neuropeptides, cytokines and kynurenine levels, and microRNAs expression).\n\nPrimary aim is to assess baseline differences among those patients who achieved a reduction of monthly migraine days \\>\u002F= 50% after three months of tretament (namely Responders) and those who did not (namely Non-responders).",[272,273,142],"Migraine Disorders","Chronic Migraine",[275,276,277,146],"migraine","anti CGRP mABs","calcitonin gene related peptide","2024-09-01",{"date":280,"type":36},"2024-09-05",{"date":282,"type":36},"2023-05-10",{"date":284,"type":20},"2026-05",{"name":42,"class":43},{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":263,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":266,"enrollmentInfo":293,"targetDuration":295,"studyType":21,"phases":4,"briefSummary":296,"conditions":297,"keywords":298,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":307,"leadSponsor":308,"locationsCount":44},"100559305","searching-for-novel-therapeutic-approaches-in-migraine-patients-resistant-to-treatments-100559305","NCT06562400","Searching for Novel Therapeutic Approaches in Migraine Patients Resistant to Treatments","SPHERA_WP2","Inclusion Criteria:\n\n* male and female patients aged 18 to 75 years\n* diagnosis of episodic migraine or chronic migraine according to ICHD-3 criteria\n* for episodic migraine: 8-14 monthly migraine days in the previous 3 months\n* diagnosis of resistant migraine, defined by having failed at least 3 classes of migraine preventatives and suffer from at least 8 debilitating monthly headache days for at least 3 consecutive months\n* patients naive to CGRP targeting treatments\n\nExclusion Criteria:\n\n* history of major psychiatric or other neurological conditions\n* diagnosis of other primary or secondary headache disorders (only sporadic tension-type headache is allowed if the patients can clearly differentiate between the 2 types of headaches)\n* clinically significant medical conditions\n* chronic pain conditions\n* alcohol and\u002For drug abuse\n* pregnancy or lactation",{"count":294,"type":20},45,"6 Months","Primary working hypothesis is that NON-responders to mAbs bear a dysfunction of the endocannabidiome system (eCBome), as suggested by pre-clinical and clinical data by our group.\n\nThey will be identified as patients showing a reduction of monthly migraine days \\\u003C 50% after three months of treatment.\n\nThe clinical, biochemical and neurofunctional impact of novel therapeutic approaches expected to interfere with eCBome will be evaluated in NON-responder patients",[272,273,142],[275,276,277,146,299,300,301,302],"HD EEG","functional MRI","brain connectivity","miocrobiome","2024-08-17",{"date":305,"type":36},"2024-08-20",{"date":282,"type":36},{"date":284,"type":20},{"name":42,"class":43},{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":263,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":266,"enrollmentInfo":316,"targetDuration":295,"studyType":21,"phases":4,"briefSummary":317,"conditions":318,"keywords":319,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":322,"leadSponsor":323,"locationsCount":44},"100559306","searching-for-novel-biological-phenotypes-in-migraine-patients-resistant-to-treatments-100559306","NCT06562413","Searching for Novel Biological Phenotypes in Migraine Patients Resistant to Treatments","SPHERA_WP1_2","Inclusion Criteria:\n\n* male and female patients aged 18 to 75 years\n* diagnosis of episodic migraine or chronic migraine according to ICHD-3 criteria\n* for episodic migraine: 8-14 monthly migraine days in the previous 3 months\n* diagnosis of resistant migraine, defined by having failed at least 3 classes of migraine preventatives and suffer from at least 8 debilitating monthly headache days for at least 3 consecutive months\n* patients naive to CGRP targeting treatments\n\nExclusion Criteria:\n\n* history of major psychiatric or other neurological conditions\n* diagnosis of other primary or secondary headache disorders (only sporadic tension-type headache is allowed if the patients can clearly differentiate between the 2 types of headaches)\n* changes in ongoing preventive treatment (if any) in the previous 3 months\n* clinically significant medical conditions\n* chronic pain conditions\n* alcohol and\u002For drug abuse\n* pregnancy or lactation",{"count":268,"type":20},"The investigators aim to define the neurofunctional phenotype of migraine patients who did not respond to at least 3 preventive treatments, including monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) pathway (NON-responders).\n\nPrimary aim will be to assess and compare changes in functional resting-state connectivity at baseline and after three months of mAbs treatment between patients who will achieve a reduction of monthly migraine days \\>\u002F= than 50% (namely Responders) and those who will not (namely Responders).\n\nThe 2 groups will undergo a neurofunctional profile by means of High Density-electroencephalogram (HD-EEG) and functional-magnetic resonance imaging (fMRI).",[272,273,142],[275,276,277,299,300,301],{"date":305,"type":36},{"date":282,"type":36},{"date":284,"type":20},{"name":42,"class":43},{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":332,"sex":16,"minAge":17,"maxAge":333,"enrollmentInfo":334,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":335,"conditions":336,"keywords":338,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":354,"locationsCount":44},"100554764","role-of-specific-micrornas-in-cluster-headache-100554764","NCT06503328","Role of Specific microRNAs in Cluster Headache","Role of Specific microRNAs in Cluster Headache: Implications for Disease Phenotype and Neuropeptide Expression","5*1000","\\- Healthy Controls\n\nInclusion Criteria:\n\n* age between \\>18 and \\\u003C65 years\n\nExclusion Criteria:\n\n* diagnosis of primary and\u002For secondary headache according to ICHD-III criteria (only diagnosis of sporadic tension type headache is allowed)\n* diagnosis of neurological disorders\n* diagnosis of medical conditions considered clinically relevant by the researcher\n* pregnant and lactating women\n* taking NSAIDs, triptans or opiates in the previous 24 hours\n* Episodic Cluster Headache\n\nInclusion Criteria:\n\n* diagnosis of Episodic Cluster Headache according to ICHD-III criteria (at least 1 year at screening)\n* age between \\>18 and \\\u003C65 years of both genders\n\nExclusion Criteria:\n\n* concomitant diagnosis of other primary and\u002For secondary headache according to ICHD-III criteria (only diagnosis of sporadic tension headache is allowed)\n* diagnosis of other neurological disorders\n* diagnosis of medical conditions considered clinically relevant by the researcher\n* diagnosis of chronic pain syndrome of any nature\n* pregnant and lactating women\n* use of substances of abuse\n* Chronic Cluster Headache\n\nInclusion Criteria:\n\n* diagnosis of Chronic Cluster Headache according to ICHD-III criteria (at least 1 year at screening)\n* age between \\>18 and \\\u003C65 years of both genders\n\nExclusion Criteria:\n\n* concomitant diagnosis of other primary and\u002For secondary headache according to ICHD-III criteria (only diagnosis of sporadic tension headache is allowed)\n* diagnosis of other neurological disorders\n* diagnosis of medical conditions considered clinically relevant by the researcher\n* diagnosis of chronic pain syndrome of any nature\n* pregnant and lactating women\n* use of substances of abuse",true,"65 Years",{"count":268,"type":20},"Cluster headache (CH) is a primary headache included in the trigeminal autonomic cephalalgias (TACs) according to the International Calssification of Headache Disorder, Third Edition. CH is characterized by a multifaceted and incompletely understood pathophysiology. Recent experimental evidence has increasingly emphasized the role of specific microRNAs (miRNAs) in the pathophysiology of primary headaches, including migraine.\n\nIn a recent study, we observed an upregulation in the gene expression of two miRNAs, miR-382-5p and miR-34a-5p, in peripheral blood mononuclear cells (PBMCs) of subjects with chronic migraine (CM). These miRNAs are involved in inflammation modulation and the release of γ-aminobutyric acid (GABA). Notably, this upregulation correlated with the migraine phenotype and its severity.\n\nSeveral neuropeptides have been established to play an active role in CH. Studies by the Danish group have demonstrated that intravenous administration of CGRP, PACAP, or VIP can induce CH attacks in at least 50% of participants in the active phase of the disease.\n\nHowever, no data currently exists regarding the potential involvement of miRNAs in CH. Given this context, the primary aim of this study is to investigate the gene expression of specific miRNAs (miR-382-5p, miR-34a-5p, and miR-155) in PBMCs and plasma levels of neuropeptides (CGRP, PACAP, VIP) in subjects with episodic CH in the active phase (eCH-act), episodic CH in the remission phase (eCH-rem), chronic CH (cCH), and healthy control subjects (HCs).",[337],"Cluster Headache",[339,340,341,342,343,344,345,346,347,144],"MicroRNA","miR-34a-5p","miR-155","miR-382-5p","Peripheral blood mononuclear cells","CGRP","PACAP","VIP","Headache","2024-07-09",{"date":350,"type":36},"2024-07-16",{"date":352,"type":36},"2023-03-01",{"date":230,"type":20},{"name":42,"class":43},{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":83,"enrollmentInfo":361,"targetDuration":4,"studyType":53,"phases":362,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":366,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":4},"100550959","effects-of-biofeedback-footwear-in-parkinsons-disease-assessment-of-functional-motor-abilities-and-locomotion-100550959","NCT06453863","Effects of Biofeedback Footwear in Parkinson's Disease: Assessment of Functional Motor Abilities and Locomotion","Inclusion Criteria:\n\n* Diagnosis of Parkinson's disease, according to the clinical diagnostic criteria of the Movement Disorders Society (Postuma RB, 2015);\n* Hoehn \\& Yahr between II and IV;\n* Stable medical therapy since at least one month before enrollment\n\nExclusion Criteria:\n\n* Concomitant diagnosis of other neurological or psychiatric disorders that may influence study assessments.;\n* MMSE score \\\u003C24;\n* Patients with DBS implant or on DuoDopa therapy;\n* Presence of relevant musculoskeletal or orthopedic pathologies;\n* Presence of relevant internal or vascular pathologies.",{"count":85,"type":20},[55],"The study aims to verify whether the use of a specific footwear providing increased plantar feedback (plantar feedback shoes) could improve gait parameters, postural control and functional performances in people with Parkinson's disease.\n\nSpecifically, the aims are:\n\n* To evaluate the acute effect of plantar feedback shoes, by comparing gait, functional and postural performances in three conditions: neutral shoes, barefoot, and plantar feedback shoes;\n* To evaluate the effect of four weeks of plantar feedback shoes, on gait, functional and postural performances.\n\nParticipants will undergo a comprehensive neurological examination, with administration of disease-specific scales (UPDRS III part 3, NFOG-q, LEDD, DASS-21). At each assessment the participants will perform an inertial gait analysis, a static posturography, and will undergo functional capacity assessments (TUG, 2MWT, 5-STST, 10- mFW).",[58,365],"Gait Disorders","NOT_YET_RECRUITING","2024-06-12",{"date":369,"type":36},"2024-06-13",{"date":371,"type":20},"2024-07-01",{"date":373,"type":20},"2025-12-01",{"name":42,"class":43},{"id":376,"slug":377,"hasResults":11,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":332,"sex":16,"minAge":333,"maxAge":383,"enrollmentInfo":384,"targetDuration":4,"studyType":53,"phases":386,"briefSummary":387,"conditions":388,"keywords":391,"overallStatus":366,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":4},"100510702","non-invasive-brain-stimulation-and-strategic-memory-training-100510702","NCT05929872","Non-invasive Brain Stimulation and Strategic Memory Training","The Efficacy of Strategic Memory Training Coupled With Non-invasive Brain Stimulation Techniques in Healthy Aging Population and Subjective Cognitive Decline Patients: a Randomized-controlled Study","StMe-tDCS","Inclusion Criteria:\n\n* MMSE ≥ 24.\n* GDS \\\u003C e uguale 11.\n* Age between 65 and 85 years.\n* Educational level ≥ 5 years.\n\nExclusion Criteria:\n\n* Pre-existing cognitive impairment (e.g. aphasia, neglect).\n* Dementia.\n* Severe disturbances in consciousness.\n* Concomitant severe psychiatric disease or other neurological conditions (e.g. depression and behavioral disorders).\n* Motor or sensory diseases that may interfere with test execution or strategic memory training.","85 Years",{"count":385,"type":20},56,[55],"Physiological aging is often associated with memory function decline. Recently, the use of transcranial direct current stimulation (tDCS), a type of non-invasive brain stimulation, has been combined with adaptive working memory training interventions in healthy older adults, providing evidence for a significant improvement in memory functions. To the best of our knowledge, no study addressed the use of strategic memory training coupled with the use of tDCS in normal aging. Strategic memory trainings allow to improve participants' performance in the practiced task and to generalize the use of memory strategies to new materials. This Randomized Controlled Trial (RCT) aims to evaluate the effectiveness of a combined intervention associating strategic memory training with the use of tDCS. Healthy older adults and participants with subjective cognitive decline will be recruited and randomly assigned to the experimental group (strategic memory training + ACTIVE tDCS) or the control group (strategic memory training + SHAM tDCS). All participants will be evaluated on transfer and practiced tasks before (T0) and after (T1) the treatment and during follow-up visits, scheduled at 1 month (T2) and 3 months (T3) after the intervention.",[389,390],"Cognitive Decline","Healthy Aging",[392,393,394,395,396],"Healthy aging","Subjective cognitive decline","Non-pharmacological treatments","Memory training","Transcranial direct current stimulation","2023-06-29",{"date":399,"type":36},"2023-07-03",{"date":401,"type":20},"2023-07-30",{"date":403,"type":20},"2026-12-30",{"name":42,"class":43},""]