Smart Digital Solutions for EARLY Treatment of COGNitive Disability (EARLY-COGN^3): A Study Protocol
<b>Background:</b> Healthy cognitive functioning is a primary component of well-being, independence, and successful aging. Cognitive deficits can arise from various conditions, such as brain injury, mental illness, and neurological disorders. Rehabilitation is a highly specialized servic...
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2025-02-01
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| author | Maria Cotelli Francesca Baglio Elena Gobbi Elena Campana Ilaria Pagnoni Giovanna Cannarella Alessandro Del Torto Federica Rossetto Angela Comanducci Gennaro Tartarisco Rocco Salvatore Calabrò Simona Campisi Raffaela Maione Claudia Saraceno Elisa Dognini Sonia Bellini Marta Bortoletto Giuliano Binetti Roberta Ghidoni Rosa Manenti |
| author_facet | Maria Cotelli Francesca Baglio Elena Gobbi Elena Campana Ilaria Pagnoni Giovanna Cannarella Alessandro Del Torto Federica Rossetto Angela Comanducci Gennaro Tartarisco Rocco Salvatore Calabrò Simona Campisi Raffaela Maione Claudia Saraceno Elisa Dognini Sonia Bellini Marta Bortoletto Giuliano Binetti Roberta Ghidoni Rosa Manenti |
| author_sort | Maria Cotelli |
| collection | DOAJ |
| description | <b>Background:</b> Healthy cognitive functioning is a primary component of well-being, independence, and successful aging. Cognitive deficits can arise from various conditions, such as brain injury, mental illness, and neurological disorders. Rehabilitation is a highly specialized service limited to patients who have access to institutional settings. In response to this unmet need, telehealth solutions are ideal for triggering the migration of care from clinics to patients’ homes. <b>Objectives:</b> The aim of EARLY-COGN^3 will be threefold: (1) to test the efficacy of a digital health at-home intervention (tele@cognitive protocol) as compared to an unstructured cognitive at-home rehabilitation in a cohort of patients with Chronic Neurological Diseases (CNDs); (2) to investigate its effects on the biomolecular and neurophysiological marker hypothesizing that people with CNDs enrolled in this telerehabilitation program will develop changes in biological markers and cortical and subcortical patterns of connectivity; (3) to analyze potential cognitive, neurobiological, and neurophysiological predictors of response to the tele@cognitive treatment. <b>Method:</b> In this single-blind, randomized, and controlled pilot study, we will assess the short- and long-term efficacy of cognitive telerehabilitation protocol (tele@cognitive) as compared to an unstructured cognitive at-home rehabilitation (Active Control Group—ACG) in a cohort of 60 people with Mild Cognitive Impairment (MCI), Subjective Cognitive Complaints (SCCs), or Parkinson’s Disease (PD). All participants will undergo a clinical, functional, neurocognitive, and quality of life assessment at the baseline (T0), post-treatment (5 weeks, T1), and at the 3-month (T2) follow-up. Neurophysiological markers and biomolecular data will be collected at T0 and T1. <b>Conclusions:</b> EARLY-COGN^3 project could lead to a complete paradigm shift from the traditional therapeutic approach, forcing a reassessment on how CNDs could take advantage of a digital solution. (clinicaltrials.gov database, ID: NCT06657274) |
| format | Article |
| id | doaj-art-83001ea05d314b1ea34a69b9405f53a2 |
| institution | OA Journals |
| issn | 2076-3425 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | MDPI AG |
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| series | Brain Sciences |
| spelling | doaj-art-83001ea05d314b1ea34a69b9405f53a22025-08-20T02:11:01ZengMDPI AGBrain Sciences2076-34252025-02-0115323910.3390/brainsci15030239Smart Digital Solutions for EARLY Treatment of COGNitive Disability (EARLY-COGN^3): A Study ProtocolMaria Cotelli0Francesca Baglio1Elena Gobbi2Elena Campana3Ilaria Pagnoni4Giovanna Cannarella5Alessandro Del Torto6Federica Rossetto7Angela Comanducci8Gennaro Tartarisco9Rocco Salvatore Calabrò10Simona Campisi11Raffaela Maione12Claudia Saraceno13Elisa Dognini14Sonia Bellini15Marta Bortoletto16Giuliano Binetti17Roberta Ghidoni18Rosa Manenti19Neuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via Pilastroni, 4, 25125 Brescia, ItalyIRCCS Fondazione Don Carlo Gnocchi—ONLUS, Via Alfonso Capecelatro, 66, 20148 Milan, ItalyNeuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via Pilastroni, 4, 25125 Brescia, ItalyNeuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via Pilastroni, 4, 25125 Brescia, ItalyNeuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via Pilastroni, 4, 25125 Brescia, ItalyNeuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via Pilastroni, 4, 25125 Brescia, ItalyNeuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via Pilastroni, 4, 25125 Brescia, ItalyIRCCS Fondazione Don Carlo Gnocchi—ONLUS, Via Alfonso Capecelatro, 66, 20148 Milan, ItalyIRCCS Fondazione Don Carlo Gnocchi—ONLUS, Via Alfonso Capecelatro, 66, 20148 Milan, ItalyNational Research Council of Italy, Institute for Biomedical Research and Innovation, C/O via Leanza, Istituto Marino, Mortelle, 98164 Messina, ItalyIRCCS Centro Neurolesi “Bonino Pulejo”, Salita Villa Contino, 21, 98124 Messina, ItalyNational Research Council of Italy, Institute for Biomedical Research and Innovation, C/O via Leanza, Istituto Marino, Mortelle, 98164 Messina, ItalyIRCCS Centro Neurolesi “Bonino Pulejo”, Salita Villa Contino, 21, 98124 Messina, ItalyMolecular Markers Laboratory, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via Pilastroni, 4, 25125 Brescia, ItalyNeurophysiology Laboratory, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via Pilastroni, 4, 25125 Brescia, ItalyMolecular Markers Laboratory, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via Pilastroni, 4, 25125 Brescia, ItalyNeurophysiology Laboratory, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via Pilastroni, 4, 25125 Brescia, ItalyMAC-Memory Clinic and Molecular Markers Laboratory, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via Pilastroni, 4, 25125 Brescia, ItalyMolecular Markers Laboratory, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via Pilastroni, 4, 25125 Brescia, ItalyNeuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via Pilastroni, 4, 25125 Brescia, Italy<b>Background:</b> Healthy cognitive functioning is a primary component of well-being, independence, and successful aging. Cognitive deficits can arise from various conditions, such as brain injury, mental illness, and neurological disorders. Rehabilitation is a highly specialized service limited to patients who have access to institutional settings. In response to this unmet need, telehealth solutions are ideal for triggering the migration of care from clinics to patients’ homes. <b>Objectives:</b> The aim of EARLY-COGN^3 will be threefold: (1) to test the efficacy of a digital health at-home intervention (tele@cognitive protocol) as compared to an unstructured cognitive at-home rehabilitation in a cohort of patients with Chronic Neurological Diseases (CNDs); (2) to investigate its effects on the biomolecular and neurophysiological marker hypothesizing that people with CNDs enrolled in this telerehabilitation program will develop changes in biological markers and cortical and subcortical patterns of connectivity; (3) to analyze potential cognitive, neurobiological, and neurophysiological predictors of response to the tele@cognitive treatment. <b>Method:</b> In this single-blind, randomized, and controlled pilot study, we will assess the short- and long-term efficacy of cognitive telerehabilitation protocol (tele@cognitive) as compared to an unstructured cognitive at-home rehabilitation (Active Control Group—ACG) in a cohort of 60 people with Mild Cognitive Impairment (MCI), Subjective Cognitive Complaints (SCCs), or Parkinson’s Disease (PD). All participants will undergo a clinical, functional, neurocognitive, and quality of life assessment at the baseline (T0), post-treatment (5 weeks, T1), and at the 3-month (T2) follow-up. Neurophysiological markers and biomolecular data will be collected at T0 and T1. <b>Conclusions:</b> EARLY-COGN^3 project could lead to a complete paradigm shift from the traditional therapeutic approach, forcing a reassessment on how CNDs could take advantage of a digital solution. (clinicaltrials.gov database, ID: NCT06657274)https://www.mdpi.com/2076-3425/15/3/239digital healthcognitive trainingnon-pharmacological interventionneurocognitive disorders |
| spellingShingle | Maria Cotelli Francesca Baglio Elena Gobbi Elena Campana Ilaria Pagnoni Giovanna Cannarella Alessandro Del Torto Federica Rossetto Angela Comanducci Gennaro Tartarisco Rocco Salvatore Calabrò Simona Campisi Raffaela Maione Claudia Saraceno Elisa Dognini Sonia Bellini Marta Bortoletto Giuliano Binetti Roberta Ghidoni Rosa Manenti Smart Digital Solutions for EARLY Treatment of COGNitive Disability (EARLY-COGN^3): A Study Protocol Brain Sciences digital health cognitive training non-pharmacological intervention neurocognitive disorders |
| title | Smart Digital Solutions for EARLY Treatment of COGNitive Disability (EARLY-COGN^3): A Study Protocol |
| title_full | Smart Digital Solutions for EARLY Treatment of COGNitive Disability (EARLY-COGN^3): A Study Protocol |
| title_fullStr | Smart Digital Solutions for EARLY Treatment of COGNitive Disability (EARLY-COGN^3): A Study Protocol |
| title_full_unstemmed | Smart Digital Solutions for EARLY Treatment of COGNitive Disability (EARLY-COGN^3): A Study Protocol |
| title_short | Smart Digital Solutions for EARLY Treatment of COGNitive Disability (EARLY-COGN^3): A Study Protocol |
| title_sort | smart digital solutions for early treatment of cognitive disability early cogn 3 a study protocol |
| topic | digital health cognitive training non-pharmacological intervention neurocognitive disorders |
| url | https://www.mdpi.com/2076-3425/15/3/239 |
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