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 | Recruiting

• 1 other identifier: EARLY-COGN^3 - PNRR-MCNT2-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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/or 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.

Conditions

Mild Cognitive Impairment (MCI); Subjective Cognitive Complaints (SCCs); Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Change in global cognition as assessed by Montreal Cognitive Assessment (MoCA)

  Montreal Cognitive Assessment (MoCA) is a screening test for global cognitive functioning. It includes tasks involving several cognitive domains: visuospatial, executive function, naming, selective and sustained attention, language, abstraction, memory and orientation (score range min= 0, max= 30, higher score=better outcome).

  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)

  Free and Cued Selective Reminding Test (FCSRT) is a measure of long-term episodic verbal memory. It provides five scores: Immediate Free Recall (IFR, spontaneous recall across three trials; score range min= 0, max= 36), Immediate Total Recall (ITR, total recall across three trials; score range min= 0, max= 36), Delayed Free Recall (DFR, score range min= 0, max= 12), Delayed Total Recall (DTR, score range min= 0, max= 12). Higher scores indicate better performance. Finally, the Index of Sensitivity to Cueing (ISC, score range min= 0, max= 1) reflects the difference between the number of items recalled spontaneously and the number of items recalled with the help of cues. A higher ISC indicates a greater sensitivity to cues.

  Baseline up to 5 weeks and 3 months

Secondary Outcomes (22)

• Change in measure of quality of life as assessed by EQ-5D-5L

  Baseline up to 5 weeks and 3 months

• Change in measure of non-motor experiences of daily living as assessed by MDS-UPDRS scale, part I

  Baseline up to 5 weeks and 3 months

• Change in measure of motor abilities as assessed by MDS-UPDRS scale, part III

  Baseline up to 5 weeks and 3 months

• Change in depressive symptoms as assessed by Hamilton Depression Rating Scale (HDRS)

  Baseline up to 5 weeks and 3 months

• Change in anxiety symptoms as assessed by State-Trait Anxiety Inventory (STAI-Y)

  Baseline up to 5 weeks and 3 months

Study Arms (2)

tele@cognitive treatment

EXPERIMENTAL

The tele@cognitive treatment group will receive a total of 5 weeks (3 sessions/week, 45 minutes/session) of home-based cognitive rehabilitation activities delivered through a digital telerehabilitation platform.

Device: RICORDO-DTx

Active Control Group (ACG)

ACTIVE COMPARATOR

The Active Control Group (ACG), will receive at-home unstructured cognitive stimulation for 5 weeks (3 sessions/week, 45 minutes/session).

Behavioral: Home-based unstructured cognitive stimulation

Interventions

RICORDO-DTx DEVICE

Tele@cognitive treatment group will receive a total of 5 weeks (3 sessions/week, 45 minutes/session) 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. Each 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.

tele@cognitive treatment

Home-based unstructured cognitive stimulation BEHAVIORAL

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/week, 45 minutes/session). They will receive, from the therapist, an instructions booklet and a participant diary.

Active Control Group (ACG)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Presence of any medical or psychiatric illness that could interfere with completing assessments;
• Presence of any medical condition representing a contraindication to TMS.

Sponsors & Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli: lead
• European Union - NextGenerationEU - PNRR M6C2 - Mission M6 - Component C2 - Investment 2.1 - Valorizzazione e potenziamento della ricerca biomedica del SSN: collaborator
• IRCCS Fondazione Don Carlo Gnocchi, Milano: collaborator
• National Research Council (CNR) - Institute for Biomedical Research and Innovation (IRIB), Messina: collaborator
• IRCCS Centro Neurolesi Bonino Pulejo, Messina: collaborator

Study Sites (3)

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

Brescia, IT, 25125, Italy

RECRUITING

IRCCS Centro Neurolesi Bonino Pulejo

Messina, IT, 98124, Italy

RECRUITING

Fondazione Don Carlo Gnocchi - ONLUS, Milan

Milan, IT, 20148, Italy

RECRUITING

Related Publications (1)

• Cotelli M, Baglio F, Gobbi E, Campana E, Pagnoni I, Cannarella G, Del Torto A, Rossetto F, Comanducci A, Tartarisco G, Calabro RS, Campisi S, Maione R, Saraceno C, Dognini E, Bellini S, Bortoletto M, Binetti G, Ghidoni R, Manenti R. Smart Digital Solutions for EARLY Treatment of COGNitive Disability (EARLY-COGN;3): A Study Protocol. Brain Sci. 2025 Feb 24;15(3):239. doi: 10.3390/brainsci15030239.

  PMID: 40149761 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Parkinson Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Maria Cotelli, PhD

CONTACT

+390303501457; mcotelli@fatebenefratelli.eu

Rosa Manenti, PhD

CONTACT

+390303501457; rmanenti@fatebenefratelli.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

IT (3)