protocolSection identificationModule nctId: NCT06278818, orgStudyIdInfo id: MNESYS-PE0000006, briefTitle: Effects of Telerehabilitation on Brain Network Connectivity, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-07, primaryCompletionDateStruct date: 2024-06-07, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University of Pavia, class: OTHER, collaborators name: University of Parma, collaborators name: University of Bologna, collaborators name: University of Rome Tor Vergata, descriptionModule briefSummary: The current project aims at assessing the impact of various cognitive telerehabilitation approaches on patients with Mild Cognitive Impairment (MCI) associated with neurodegenerative diseases, namely Alzheimer's disease (AD) and Parkinson's disease (PD). The study focuses on non-pharmacological interventions to maintain patients' residual functionality, limit disease progression, and improve quality of life for both patients and their caregivers.This longitudinal and multicenter study applies innovative cognitive telerehabilitation (TR) methods and evaluates their impact on functional parameters obtained with high-density electroencephalogram (HD-EEG) and resting-state functional magnetic resonance imaging (rsFMRI). The goal is to identify neurophysiological correlates of the effects of three different cognitive TR in individuals with MCI due to neurodegenerative conditions.The study aims to:* Identify correlations between improvement in cognitive performance and functional brain data.* Use acquired knowledge to develop neurologically guided TR approaches for broader use.The research will include patients diagnosed with MCI associated with neurodegenerative diseases. Primary outcome measures include changes in resting-state brain connectivity assessed through HD-EEG and rsFMRI. Secondary outcomes involve the assessment of changes in neuropsychological measures, caregiver burden, immediately after rehabilitation and after longitudinal follow-up.The study is designed to last 30 months, with follow-up assessments at three time points. The primary outcomes will be evaluated using rsFMRI and HD-EEG instrumental acquisitions, the secondary outcomes will be evaluated using clinical assessments and neuropsychological tests., conditionsModule conditions: Mild Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The neurophysiologist and neuroradiologist will be blinded to the type of rehabilitation treatment (experimental group vs. control)., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Telerehabilitation, interventions name: Control Condition, outcomesModule primaryOutcomes measure: Changes in resting-state brain networks functional connectivity after NBTC treatment, primaryOutcomes measure: Changes in resting-state EEG coherence after NBTC treatment, primaryOutcomes measure: Changes in resting-state EEG coherence after HomeCore treatment, primaryOutcomes measure: Changes in resting-state brain networks functional connectivity after SMRT treatment, secondaryOutcomes measure: Changes in neuropsychological and caregiver burden measures after TR, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Mondino Foundation, status: RECRUITING, city: Pavia, zip: 27100, country: Italy, contacts name: Cristina Tassorelli, MD, role: CONTACT, phone: 0382380419, phoneExt: 0039, email: cristina.tassorelli@unipv.it, contacts name: Silvia Paola P Caminiti, PhD, role: CONTACT, phone: 0382380419, phoneExt: 0039, email: silviapaola.caminiti@unipv.it, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False