Computerized Cognitive Training in Neurodegenerative Diseases (NDD2019)

NCT04111640 | Unknown

• 1 other identifier: NDD2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

neurodegenerative diseas; non-pharmacological treatments; cognitive training

Outcome Measures

Primary Outcomes (2)

• Change in Global cognitive functioning measured by Mini-Mental State Examination (MMSE)

  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.

  After 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program

• Change in Global cognitive functioning measured by Montreal Overall Cognitive Assessment (MoCA)

  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.

  After 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program

Secondary Outcomes (5)

• Change in Memory

  after 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program

• Change in executive functions

  after 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program

• Change in Mood (assessed by Beck Depression Inventory - BDI)

  after 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program

• Change in Quality of life (assessed by Short Form-36 Health Survey - SF-36)

  after 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program

• Change in The evolution of cognitive profile (assessed by Clinical Dementia Rating Scale - CDR)

  after 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program

Study Arms (2)

Experimental group

EXPERIMENTAL

A computer-supported cognitive training for the training of logical-executive and working-memory functions (CoRe software)

Other: Control Group

Control Group

OTHER

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

Other: CoRe software

Interventions

CoRe software OTHER

Computer-supported cognitive training (CT)

Control Group

Control Group OTHER

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

Experimental group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead

Study Sites (1)

Struttura Semplice Neuropsicologia Clinica/ Centro UVA

Pavia, 27100, Italy

RECRUITING

Related Publications (10)

• Mayeux R, Stern Y. Epidemiology of Alzheimer disease. Cold Spring Harb Perspect Med. 2012 Aug 1;2(8):a006239. doi: 10.1101/cshperspect.a006239.

  PMID: 22908189 BACKGROUND

• Belleville S. Cognitive training for persons with mild cognitive impairment. Int Psychogeriatr. 2008 Feb;20(1):57-66. doi: 10.1017/S104161020700631X. Epub 2007 Oct 25.

  PMID: 17958927 BACKGROUND

• Jean L, Bergeron ME, Thivierge S, Simard M. Cognitive intervention programs for individuals with mild cognitive impairment: systematic review of the literature. Am J Geriatr Psychiatry. 2010 Apr;18(4):281-96. doi: 10.1097/JGP.0b013e3181c37ce9.

  PMID: 20220584 BACKGROUND

• Robert PH, Konig A, Amieva H, Andrieu S, Bremond F, Bullock R, Ceccaldi M, Dubois B, Gauthier S, Kenigsberg PA, Nave S, Orgogozo JM, Piano J, Benoit M, Touchon J, Vellas B, Yesavage J, Manera V. Recommendations for the use of Serious Games in people with Alzheimer's Disease, related disorders and frailty. Front Aging Neurosci. 2014 Mar 24;6:54. doi: 10.3389/fnagi.2014.00054. eCollection 2014.

  PMID: 24715864 BACKGROUND

• Walton CC, Naismith SL, Lampit A, Mowszowski L, Lewis SJ. Cognitive Training in Parkinson's Disease. Neurorehabil Neural Repair. 2017 Mar;31(3):207-216. doi: 10.1177/1545968316680489. Epub 2016 Dec 13.

  PMID: 27899737 BACKGROUND

• Coyle H, Traynor V, Solowij N. Computerized and virtual reality cognitive training for individuals at high risk of cognitive decline: systematic review of the literature. Am J Geriatr Psychiatry. 2015 Apr;23(4):335-359. doi: 10.1016/j.jagp.2014.04.009. Epub 2014 May 14.

  PMID: 24998488 BACKGROUND

• Bernini S, Alloni A, Panzarasa S, Picascia M, Quaglini S, Tassorelli C, Sinforiani E. A computer-based cognitive training in Mild Cognitive Impairment in Parkinson's Disease. NeuroRehabilitation. 2019;44(4):555-567. doi: 10.3233/NRE-192714.

  PMID: 31256092 BACKGROUND

• Alloni A, Quaglini S, Panzarasa S, Sinforiani E, Bernini S. Evaluation of an ontology-based system for computerized cognitive rehabilitation. Int J Med Inform. 2018 Jul;115:64-72. doi: 10.1016/j.ijmedinf.2018.04.005. Epub 2018 Apr 21.

  PMID: 29779721 BACKGROUND

• Alloni A, Sinforiani E, Zucchella C, Sandrini G, Bernini S, Cattani B, Pardell DT, Quaglini S, Pistarini C. Computer-based cognitive rehabilitation: the CoRe system. Disabil Rehabil. 2017 Feb;39(4):407-417. doi: 10.3109/09638288.2015.1096969. Epub 2015 Oct 27.

  PMID: 26505323 BACKGROUND

• Bernini S, Panzarasa S, Barbieri M, Sinforiani E, Quaglini S, Tassorelli C, Bottiroli S. A double-blind randomized controlled trial of the efficacy of cognitive training delivered using two different methods in mild cognitive impairment in Parkinson's disease: preliminary report of benefits associated with the use of a computerized tool. Aging Clin Exp Res. 2021 Jun;33(6):1567-1575. doi: 10.1007/s40520-020-01665-2. Epub 2020 Sep 8.

  PMID: 32895890 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Elena Sinforiani, MD

  IRCCS Mondino Foundation, Pavia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cinzia Fattore, MD

CONTACT

0039 0382 380385; cinzia.fattore@mondino.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment, prospective, double-blind, randomized, controlled study

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: October 1, 2019
• Study Start: March 15, 2017
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)