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Computerized Cognitive Training in Neurodegenerative Diseases (NDD2019) (NDD2019)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111640
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
IRCCS National Neurological Institute "C. Mondino" Foundation

Brief 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.


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Other: CoRe software Other: Control Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment, prospective, double-blind, randomized, controlled study
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)

Control Group
Paper and pencil cognitive training (paper-and-pencil CoRe version)
Other: CoRe software
Computer-supported cognitive training (CT)




Primary Outcome Measures :
  1. 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.

  2. 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.



Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of idiopathic PD according to UKPDBB criteria (Hughes, Daniel, Kilford, & Lees, 1992) and Hoehn&Yahr scale≤4 (Hoehn & Yahr, 1967);
  • presence of PD-MCI single-domain (executive) or PD-MCI multiple-domain with executive involvement (Litvan et al., 2012);
  • age between 50 and 85 years;
  • education level ≥5 years.

Exclusion Criteria:

  • pre-existing cognitive impairment (e.g. aphasia,neglect);
  • severe disturbances in consciousness;
  • severe sensory or motor disturbances that do not allow the patient to control the trunk or to maintain the sitting position; in particular patients with disturbing resting and/or action tremor (corresponding to score 2-4 in the specific items of Unified Parkinson's Disease Rating Scale (UPDRS III) (Fahn,1987) were excluded;
  • concomitant severe psychiatric or neurological conditions;
  • patients with Deep Brain Stimulation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111640


Contacts
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Contact: Cinzia Fattore, MD 0039 0382 380385 cinzia.fattore@mondino.it

Locations
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Italy
Struttura Semplice Neuropsicologia Clinica/ Centro UVA Recruiting
Pavia, Italy, 27100
Contact: Sara Bottiroli, Psychologist    0382380290    sara.bottiroli@mondino.it   
Sponsors and Collaborators
IRCCS National Neurological Institute "C. Mondino" Foundation
Investigators
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Principal Investigator: Elena Sinforiani, MD IRCCS Mondino Foundation, Pavia
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: IRCCS National Neurological Institute "C. Mondino" Foundation
ClinicalTrials.gov Identifier: NCT04111640    
Other Study ID Numbers: NDD2019
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IRCCS National Neurological Institute "C. Mondino" Foundation:
neurodegenerative diseas
non-pharmacological treatments
cognitive training
Additional relevant MeSH terms:
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Neurodegenerative Diseases
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Nervous System Diseases