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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

NCT06657274 · IRCCS Centro San Giovanni di Dio Fatebenefratelli
In plain English

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About this study
60 subjects with MCI, SCC, PD will be recruited from IRCCS Istituto Centro San Giovanni di Dio, Fatebenefratelli, Brescia, Fondazione Don Carlo Gnocchi - ONLUS, Milan and IRCCS Centro Neurolesi Bonino Pulejo, Messina. Patients will include both male and female subjects affected by CND: PD (Hoehn \& Yahr\<3), MCI (with CDR scale≤0.5, MMSE ≥24) and SCC (Subjective Cognitive Complaints). All patients will undergo treatment sessions of 45 minutes, 3 days a week for 5 weeks: * 30 subjects will be assigned to the tele@cognitive group that will receive home-based cognitive telerehabilitation activities with an innovative digital solution for remote rehabilitation of cognitive difficulties according to the digital therapy delivery model; * 30 subjects will be assigned to the Active Control Group (ACG) that will receive home-based unstructured cognitive stimulation. The two groups will be matched for sex, age, education and performance in the MoCA test. All study participants will be administered a multidimensional assessment by an experienced neuropsychologist at baseline (T0), at post-treatment assessment (T1, 5 weeks from T0) and at 3-month follow-up (T2). In addition, participation in the research involves blood sampling and application of Transcranial Magnetic Stimulation (TMS) before (T0) and after (T1) treatment.
Eligibility criteria
Inclusion Criteria: * Diagnosis of PD (Hoehn \& Yahr\<3); MCI (with CDR scale≤0.5, MMSE ≥24), and SCC (Subjective Cognitive Complaints); * Montreal Cognitive Assessment (MoCA) corrected score ≥17.36 * Education ≥ 5 years * Age eligible for the study: 18≤age≤85 * Native Italian speakers * Absence of marked hearing/visual impairment * All of the subjects will have normal or corrected-to-normal vision. * Agreement to participate by signing the informed consent form * Availability of a caregiver/study partner able to support the participant * No rehabilitation program in place at the time of enrolment or in the last 3 months before enrolment * Stable drug treatment (last 3 months), if any Exclusion Criteria: * Presence of any medical or psychiatric illness that could interfere with completing assessments; * Presence of any medical condition representing a contraindication to TMS.
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-12-09
Estimated completion: 2026-08-30
Last updated: 2025-05-02
Interventions
Device: RICORDO-DTxBehavioral: Home-based unstructured cognitive stimulation
Primary outcomes
  • Change in global cognition as assessed by Montreal Cognitive Assessment (MoCA) (Baseline up to 5 weeks and 3 months)
  • Change in long-term episodic verbal memory as assessed by Free and Cued Selective Reminding Test (FCSRT) (Baseline up to 5 weeks and 3 months)
Sponsor
IRCCS Centro San Giovanni di Dio Fatebenefratelli · other
With: European Union - NextGenerationEU - PNRR M6C2 - Mission M6 - Component C2 - Investment 2.1 - Valorizzazione e potenziamento della ricerca biomedica del SSN, IRCCS Fondazione Don Carlo Gnocchi, Milano, National Research Council (CNR) - Institute for Biomedical Research and Innovation (IRIB), Messina, IRCCS Centro Neurolesi Bonino Pulejo, Messina
Contacts & investigators
ContactMaria Cotelli, PhD · contact · mcotelli@fatebenefratelli.eu · +390303501457
ContactRosa Manenti, PhD · contact · rmanenti@fatebenefratelli.eu · +390303501457
All locations (3)
IRCCS Istituto Centro San Giovanni di Dio FatebenefratelliRecruiting
Brescia, IT, Italy
IRCCS Centro Neurolesi Bonino PulejoRecruiting
Messina, IT, Italy
Fondazione Don Carlo Gnocchi - ONLUS, MilanRecruiting
Milan, IT, Italy
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 · TrialPath