Computerized Cognitive Training in Neurodegenerative Diseases (NDD2019)

NCT04111640 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-10-01

No results posted yet for this study

Summary

The prevalence of neurodegenerative diseases is expected to increase over the next years, in parallel to the aging of the world population. Therefore, research efforts need to be devoted to evaluate intervention strategies that delay the onset of cognitive decline. Given the paucity of pharmacological interventions, strategies for non-pharmacological enhancement, such as cognitive training, are receiving increasing attention. Moreover, the advances in the development of Information \& Communication Technologies (ICT) has recently prompted the possibility to develop computer-based solution, also called Serious Game (SG), for the training of one or more cognitive functions. This approach could help overcome the limits of traditional paper-and-pencil cognitive intervention techniques. However, the clinical, ethical, economic and research impact of the use of these computer-based solutions in these target populations is still under discussion. In order to acquire more academic and professional credibility and acceptance, researchers need to collect more data to test and evolve usability and usefulness of SG as clinical tools targeting people with dementia-related disorders.

The general aim of this research is to evaluate the effects of a computer-supported Cognitive Training (CT) compared to a paper-and-pencil CT, in the early stage of neurodegenerative diseases. Patients with Mild Cognitive Impairment (MCI) are enrolled and randomly assigned to the experimental group (CoRe software) or control group (paper-and-pencil CoRe version). All patients are evaluated before (T0) and after (T1) treatment with an exhaustive neuropsychological assessment. Furthermore, follow-up visits are scheduled 6 months (T2) and 12 months (T3) after the end of the treatment.

Conditions

Interventions

OTHER

CoRe software

Computer-supported cognitive training (CT)

OTHER

Control Group

Paper and pencil cognitive training (paper-and-pencil CoRe version)

Sponsors & Collaborators

  • IRCCS National Neurological Institute "C. Mondino" Foundation

    lead OTHER

Principal Investigators

  • Elena Sinforiani, MD · IRCCS Mondino Foundation, Pavia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-15
Primary Completion
2020-12-15
Completion
2020-12-15

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04111640 on ClinicalTrials.gov