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.
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
Presence of any medical or psychiatric illness that could interfere with completing assessments;
Presence of any medical condition representing a contraindication to TMS.
Parallel
RICORDO-DTx
DeviceTele@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.
Home-based unstructured cognitive stimulation
BehavioralSubjects 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.
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).
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.
Change in measure of quality of life as assessed by EQ-5D-5L
EQ-5D-5L is a measure of health status consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has three response levels (no problems, some problems, unable to/extreme problems). In addition, the questionnaire includes a visual analog scale that records the patient's perception of his or her overall health (score range: min= 0, max= 100, higher score=better outcome).
Change in measure of non-motor experiences of daily living as assessed by MDS-UPDRS scale, part I
MDS-UPDRS scale, part I (only for PD patients) is a measure of non-motor experiences of daily living consisting of a total of 13 questions (score range min= 0, max= 52, higher score= worse outcome).
Change in measure of motor abilities as assessed by MDS-UPDRS scale, part III
MDS-UPDRS scale, part III (only for PD patients) is a measure of motor abilities consisting of a total of 18 questions with 33 individual items. Each item has a 0-4 rating, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe (score range: min= 0, max= 132, higher score=worse outcome).
Change in depressive symptoms as assessed by Hamilton Depression Rating Scale (HDRS)
Hamilton Depression Rating Scale (HDRS) is a measure of severity of depressive symptoms consisting of a total of 21 items (score range min= 0, max= 64, higher score=worse outcome).
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IRCCS Centro San Giovanni di Dio Fatebenefratelli
Lead sponsor
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
