[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566599":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":41,"responsibleParty":90,"collaborators":92,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":26,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"IRCCS Centro San Giovanni di Dio Fatebenefratelli","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"tele@cognitive treatment","EXPERIMENTAL","The tele@cognitive treatment group will receive a total of 5 weeks (3 sessions\u002Fweek, 45 minutes\u002Fsession) of home-based cognitive rehabilitation activities delivered through a digital telerehabilitation platform.",[13],"Device: RICORDO-DTx",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Control Group (ACG)","ACTIVE_COMPARATOR","The Active Control Group (ACG), will receive at-home unstructured cognitive stimulation for 5 weeks (3 sessions\u002Fweek, 45 minutes\u002Fsession).",[19],"Behavioral: Home-based unstructured cognitive stimulation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","RICORDO-DTx","Tele@cognitive treatment group will receive a total of 5 weeks (3 sessions\u002Fweek, 45 minutes\u002Fsession) of home-based cognitive rehabilitation activities with an innovative digital solution for remote rehabilitation of cognitive difficulties according to digital therapeutics delivery model. Subjects assigned to the tele@cognitive group can access the app RICORDO-DTx through a tablet showing the prescribed rehabilitation activities to be performed.\n\nEach cognitive exercise is structured into five levels of difficulty that adaptively increase (algorithm on both subject's performance and perceived difficulty). All data about patient progress and adherence will be collected with this digital solution and will be available to evaluate and monitor the results of rehabilitation.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BEHAVIORAL","Home-based unstructured cognitive stimulation","Subjects assigned to the home-based unstructured cognitive stimulation will be requested to work on detailed activities for the same duration of the tele@cognitive intervention (3 sessions\u002Fweek, 45 minutes\u002Fsession). They will receive, from the therapist, an instructions booklet and a participant diary.",[15],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Maria Cotelli, PhD","CONTACT","+390303501457","mcotelli@fatebenefratelli.eu",{"name":39,"role":35,"phone":36,"phoneExt":26,"email":40},"Rosa Manenti, PhD","rmanenti@fatebenefratelli.eu",[42,60,75],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":46,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli","RECRUITING","Brescia","IT","25125","Italy",{"type":50,"coordinates":51},"Point",[52,53],10.21472,45.53558,{"lat":53,"lon":52},[56,57,58],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},{"name":39,"role":35,"phone":36,"phoneExt":26,"email":40},{"name":34,"role":59,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":61,"status":44,"city":62,"state":46,"zip":63,"country":48,"countryCode":46,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"IRCCS Centro Neurolesi Bonino Pulejo","Messina","98124",{"type":50,"coordinates":65},[66,67],15.55256,38.19394,{"lat":67,"lon":66},[70,74],{"name":71,"role":35,"phone":72,"phoneExt":26,"email":73},"Rocco S Calabrò, MD","+3909060128123","roccos.calabro@irccsme.it",{"name":71,"role":59,"phone":26,"phoneExt":26,"email":26},{"facility":76,"status":44,"city":77,"state":46,"zip":78,"country":48,"countryCode":46,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Fondazione Don Carlo Gnocchi - ONLUS, Milan","Milan","20148",{"type":50,"coordinates":80},[81,82],9.18951,45.46427,{"lat":82,"lon":81},[85,89],{"name":86,"role":35,"phone":87,"phoneExt":26,"email":88},"Francesca Baglio, MD","+390240308069","fbaglio@dongnocchi.it",{"name":86,"role":59,"phone":26,"phoneExt":26,"email":26},{"type":91,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[93,96,98,100],{"name":94,"class":95},"European Union - NextGenerationEU - PNRR M6C2 - Mission M6 - Component C2 - Investment 2.1 - Valorizzazione e potenziamento della ricerca biomedica del SSN","UNKNOWN",{"name":97,"class":95},"IRCCS Fondazione Don Carlo Gnocchi, Milano",{"name":99,"class":95},"National Research Council (CNR) - Institute for Biomedical Research and Innovation (IRIB), Messina",{"name":101,"class":95},"IRCCS Centro Neurolesi Bonino Pulejo, Messina","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",false,"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.","ALL","18 Years","85 Years",{"count":113,"type":114},60,"ESTIMATED","INTERVENTIONAL",[117],"NA","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.",[120,121,122],"Mild Cognitive Impairment (MCI)","Subjective Cognitive Complaints (SCCs)","Parkinson Disease","2025-04-30",{"date":125,"type":126},"2025-05-02","ACTUAL",{"date":128,"type":126},"2024-12-09",{"date":130,"type":114},"2026-08-30",{"name":5,"class":6},3]