Computerized Cognitive Training in Neurodegenerative Diseases (NDD2019) (NDD2019)
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|ClinicalTrials.gov Identifier: NCT04111640|
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Other: CoRe software Other: Control Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel assignment, prospective, double-blind, randomized, controlled study|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluation of the Effectiveness of a Computerized Cognitive Training in the Early Stages of Neurodegenerative Diseases|
|Actual Study Start Date :||March 15, 2017|
|Estimated Primary Completion Date :||December 15, 2020|
|Estimated Study Completion Date :||December 15, 2020|
Experimental: Experimental group
A computer-supported cognitive training for the training of logical-executive and working-memory functions (CoRe software)
Other: Control Group
Paper and pencil cognitive training (paper-and-pencil CoRe version)
Paper and pencil cognitive training (paper-and-pencil CoRe version)
Other: CoRe software
Computer-supported cognitive training (CT)
- Change in Global cognitive functioning measured by Mini-Mental State Examination (MMSE) [ Time Frame: After 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program ]It is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. The score is between 0-30. Lower score is worse cognitive functioning.
- Change in Global cognitive functioning measured by Montreal Overall Cognitive Assessment (MoCA) [ Time Frame: After 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program ]
It is a widely used screening assessment for detecting cognitive impairment. It assesses several cognitive domains:
The short-term memory recall task (5 points). Visuospatial abilities a clock-drawing task (3 points) and a three-dimensional cube copy (1 point).
Multiple aspects of executive functions are assessed using an alternation task adapted from the trail-making B task (1 point), a phonemic fluency task (1 point), and a two-item verbal abstraction task (2 points).
Attention, concentration, and working memory are evaluated using a sustained attention task ( 1 point), a serial subtraction task (3 points), and digits forward and backward (1 point each).
Language is assessed using a three-item confrontation naming task with low-familiarity animals (3 points), repetition of two syntactically complex sentences (2 points), and the aforementioned fluency task.
Finally, orientation to time and place (6 points). Low score is worse outcome.
- Change in Memory [ Time Frame: after 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program ]Verbal and spatial span; verbal long-term memory; spatial long-term memory by using scales. Higher scores are better outcomes
- Change in executive functions [ Time Frame: after 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program ]Logical-executive functions; attention; visuospatial abilities by using scales. Higher scores are better outcomes
- Change in Mood (assessed by Beck Depression Inventory - BDI) [ Time Frame: after 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program ]Contains 21 questions. The items are rated on a 4-point severity scale (0-3) and are summed to give a total score (range 0-63). A higher score denotes more severe depression.
- Change in Quality of life (assessed by Short Form-36 Health Survey - SF-36) [ Time Frame: after 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program ]Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Low score is worse quality of life.
- Change in The evolution of cognitive profile (assessed by Clinical Dementia Rating Scale - CDR) [ Time Frame: after 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program ]CDR is a widely utilized clinical tool for grading the relative severity of dementia with scores that range from 0 (no impairment) to 3 (severe impairment).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111640
|Contact: Cinzia Fattore, MD||0039 0382 firstname.lastname@example.org|
|Struttura Semplice Neuropsicologia Clinica/ Centro UVA||Recruiting|
|Pavia, Italy, 27100|
|Contact: Sara Bottiroli, Psychologist 0382380290 email@example.com|
|Principal Investigator:||Elena Sinforiani, MD||IRCCS Mondino Foundation, Pavia|