Mild Cognitive ImpairmentNDD2019NCT04111640
Computerized Cognitive Training in Neurodegenerative Diseases (NDD2019)
A study testing CoRe software in people with Mild Cognitive Impairment, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- CoRe software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2017to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Struttura Semplice Neuropsicologia Clinica/ Centro UVA
Pavia, 27100
Sara Bottiroli, Psychologist, 0382380290, sara.bottiroli@mondino.it
About this study
Official title: Evaluation of the Effectiveness of a Computerized Cognitive Training in the Early Stages of Neurodegenerative Diseases
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.
Read the detailed description
Serious games (SG), are digital applications specialized for purpose other than entertaining. These technology devices could help to overcome the limits of traditional paper-and-pencil approaches. These traditional interventions, even if particular familiar to older patients, involve indeed some disadvantages, such as data management and analysis particularly complex for therapists; possible learning effects related to stimuli, boredom and reduction of the patient's compliance.
Conversely, SG uses motivational cues and provides real-time feedback; task complexity and response time demands may change frequently during and across sessions, in accordance with changes in individual performance. This allows to avoid over- or under-stimulation and to train areas of relative weakness. Computer support also saves time for therapists in the preparation of exercises and allows to record all session parameters for further statistics. Talking about disadvantages, the more critical is that elderly people might have poor information technology skills with a consequent lack of familiarity with technological devices. These difficulties derive from the fact that most of the SG used have been developed for entertainment purposes (e.g., the Nintendo Wii Fit, Wii Sports, and Big Brain Academy) and for a "typical healthy user" in mind. Some practical recommendations for the usability and usefulness of SG as clinical tools in dementia-related disorders were collected, but there is still no a general consensus about how, when and for what purpose these digital games should be developed. In fact, in the contest of neurodegenerative disease, cognitive intervention to be effective must be proportionate to the degree of cognitive deterioration and consequently it is necessary to take into account the phases of the disease, the specific disease characteristics and the specific cognitive domains affected. Some studies suggested that computerized CT is efficacious at the early phases of the disease, or where MCI is present, while it may not be beneficial at the dementia stage. Though these emerging results are encouraging, some issue about the use of this computer-based solution as clinical tools remain unresolved.
In this frame, we develop a computer-based CT (CoRe software) for the training of logical-executive and working-memory functions. We aim to assess the efficacy of this computer-supported CT compared to a paper-and-pencil CoRe version. This could be useful for two main reasons: 1) understand the comparability of the two interventions; 2) explore possible extra advantages of the CoRe software with respect to the paper-and-pencil version that could make it more suitable for the clinical routine.
CoRe is an ontology-based software tool that allows several degrees of personalization and the possibility to generate different patient-tailored exercises; for a more detailed description see previous papers.
Inpatients with idiopathic PD are recruited from the Neurorehabilitation Unit of the IRCCS Mondino Foundation. The diagnosis of mild dementia or PD-MCI is formulated on the basis of a comprehensive neuropsychological evaluation (baseline cognitive assessment - T0) according to the guidelines presented in the literature. The following standardized tests assessing different domains are used:
- global cognitive function: Mini-Mental State Examination (MMSE) and Montreal Montreal Overall Cognitive Assessment (MoCA);
- memory: verbal (Verbal Span; Digit Span) and spatial (Corsi's blocktapping test - CBTT) span; verbal long-term memory (Logical Memory Test immediate and delayed recall; Rey's 15-word test immediate and delayed recall); spatial long-term memory (Rey Complex Figure delayed recall - RCF-dr);
- logical-executive functions: non-verbal reasoning; frontal functionality (Frontal Assessment Battery - FAB); semantic fluency (animals, fruits, car brands), phonological fluency (FAS);
- attention: visual selective attention (Attentive Matrices); simple speed processing and complex attention (Trail Making Test parts A - TMT A and part B - TMT B);
- visuospatial abilities: constructive apraxia Rey Complex Figure copy - RCF-copy.
The same battery is also used at the post-training assessment (T1) and at the follow-up visits six months (T2) and one year after (T3). Parallel versions are applied when available (verbal long-term memory tests), in order to avoid the learning effect. All the test scores are corrected for age, sex, and education and compared with the values available for the Italian population.
At the baseline, the cognitive reserve is assessed using Cognitive Reserve Index questionnaire (CRIq). The patients' functional status is assessed using Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) at the baseline and at the last follow-up visit after one year (T3). Moreover, mood is assessed using the Beck Depression Inventory (BDI) at the baseline and at the follow-up visits (T1, T2 and T3), while quality of life is assessed using the 36-Item Short Form Health Survey questionnaire (SF-36) at the baseline and at the follow-up visits six months (T2) and one year (T3) after training.
This study is a prospective, double-blind Randomized Controlled Trial. All the patients recruited undergo baseline cognitive assessment (T0). Patients who meet the inclusion and exclusion criteria are enrolled and randomly assigned to the experimental group (CoRe software) or control group (paper-and-pencil CoRe version). CT program consists of 12 individual sessions (3 sessions/week) each lasting 45 minutes of computer-based or paper-and-pencil logical-executive and working-memory tasks.
All the patients are evaluated at the end of the 3-weeks training (T1), to detect the training effect, and six month (T2) and one year (T3) after the end of CT to assess the persistence of the training-related improvement and also to evaluate the impact of CT on the evolution of cognitive decline.
- Conditions
- Mild Cognitive Impairment
- Being tested
- CoRe software, Control Group
- Keywords
- neurodegenerative diseas, non-pharmacological treatments, cognitive training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoRe softwareOther
Computer-supported cognitive training (CT)
Control GroupOther
Paper and pencil cognitive training (paper-and-pencil CoRe version)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | A computer-supported cognitive training for the training of logical-executive and working-memory functions (CoRe software) Receives: Other: Control Group |
| Control Group | Other | Paper and pencil cognitive training (paper-and-pencil CoRe version) Receives: Other: CoRe software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Verbal and spatial span; verbal long-term memory; spatial long-term memory by using scales. Higher scores are better outcomes
Measured: after 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program
Change in executive functions
Logical-executive functions; attention; visuospatial abilities by using scales. Higher scores are better outcomes
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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).
Measured: after 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start15 Mar 2017
- Primary completion15 Dec 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment, prospective, double-blind, randomized, controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Sinforiani, MD, Principal investigator, IRCCS Mondino Foundation, Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111640
- Sponsor's protocol ID
- NDD2019
- Acronym
- NDD2019
- Status last verified
- Sep 2019
- First submitted
- 12 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mayeux R, Stern Y. Epidemiology of Alzheimer disease. Cold Spring Harb Perspect Med. 2012 Aug 1;2(8):a006239. doi: 10.1101/cshperspect.a006239.
PubMed 22908189Belleville 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.
PubMed 17958927Jean 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.
PubMed 20220584Robert 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.
PubMed 24715864Walton 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.
PubMed 27899737Coyle 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.
PubMed 24998488Bernini 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.
PubMed 31256092Alloni 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.
PubMed 29779721Alloni 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.
PubMed 26505323Bernini 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.
PubMed 32895890
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Computerized Cognitive Training in the Early Stages of Neurodegenerative Diseases
- ClinicalTrials.gov ID
- NCT04111640
- Acronym / sponsor ID
- NDD2019 / NDD2019
- Conditions
- Mild Cognitive Impairment
- Keywords
- neurodegenerative diseas, non-pharmacological treatments, cognitive training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Serious games (SG), are digital applications specialized for purpose other than entertaining. These technology devices could help to overcome the limits of traditional paper-and-pencil approaches. These traditional interventions, even if particular familiar to older patients, involve indeed some disadvantages, such as data management and analysis particularly complex for therapists; possible learning effects related to stimuli, boredom and reduction of the patient's compliance.
Conversely, SG uses motivational cues and provides real-time feedback; task complexity and response time demands may change frequently during and across sessions, in accordance with changes in individual performance. This allows to avoid over- or under-stimulation and to train areas of relative weakness. Computer support also saves time for therapists in the preparation of exercises and allows to record all session parameters for further statistics. Talking about disadvantages, the more critical is that elderly people might have poor information technology skills with a consequent lack of familiarity with technological devices. These difficulties derive from the fact that most of the SG used have been developed for entertainment purposes (e.g., the Nintendo Wii Fit, Wii Sports, and Big Brain Academy) and for a "typical healthy user" in mind. Some practical recommendations for the usability and usefulness of SG as clinical tools in dementia-related disorders were collected, but there is still no a general consensus about how, when and for what purpose these digital games should be developed. In fact, in the contest of neurodegenerative disease, cognitive intervention to be effective must be proportionate to the degree of cognitive deterioration and consequently it is necessary to take into account the phases of the disease, the specific disease characteristics and the specific cognitive domains affected. Some studies suggested that computerized CT is efficacious at the early phases of the disease, or where MCI is present, while it may not be beneficial at the dementia stage. Though these emerging results are encouraging, some issue about the use of this computer-based solution as clinical tools remain unresolved.
In this frame, we develop a computer-based CT (CoRe software) for the training of logical-executive and working-memory functions. We aim to assess the efficacy of this computer-supported CT compared to a paper-and-pencil CoRe version. This could be useful for two main reasons: 1) understand the comparability of the two interventions; 2) explore possible extra advantages of the CoRe software with respect to the paper-and-pencil version that could make it more suitable for the clinical routine.
CoRe is an ontology-based software tool that allows several degrees of personalization and the possibility to generate different patient-tailored exercises; for a more detailed description see previous papers.
Inpatients with idiopathic PD are recruited from the Neurorehabilitation Unit of the IRCCS Mondino Foundation. The diagnosis of mild dementia or PD-MCI is formulated on the basis of a comprehensive neuropsychological evaluation (baseline cognitive assessment - T0) according to the guidelines presented in the literature. The following standardized tests assessing different domains are used:
- global cognitive function: Mini-Mental State Examination (MMSE) and Montreal Montreal Overall Cognitive Assessment (MoCA);
- memory: verbal (Verbal Span; Digit Span) and spatial (Corsi's blocktapping test - CBTT) span; verbal long-term memory (Logical Memory Test immediate and delayed recall; Rey's 15-word test immediate and delayed recall); spatial long-term memory (Rey Complex Figure delayed recall - RCF-dr);
- logical-executive functions: non-verbal reasoning; frontal functionality (Frontal Assessment Battery - FAB); semantic fluency (animals, fruits, car brands), phonological fluency (FAS);
- attention: visual selective attention (Attentive Matrices); simple speed processing and complex attention (Trail Making Test parts A - TMT A and part B - TMT B);
- visuospatial abilities: constructive apraxia Rey Complex Figure copy - RCF-copy.
The same battery is also used at the post-training assessment (T1) and at the follow-up visits six months (T2) and one year after (T3). Parallel versions are applied when available (verbal long-term memory tests), in order to avoid the learning effect. All the test scores are corrected for age, sex, and education and compared with the values available for the Italian population.
At the baseline, the cognitive reserve is assessed using Cognitive Reserve Index questionnaire (CRIq). The patients' functional status is assessed using Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) at the baseline and at the last follow-up visit after one year (T3). Moreover, mood is assessed using the Beck Depression Inventory (BDI) at the baseline and at the follow-up visits (T1, T2 and T3), while quality of life is assessed using the 36-Item Short Form Health Survey questionnaire (SF-36) at the baseline and at the follow-up visits six months (T2) and one year (T3) after training.
This study is a prospective, double-blind Randomized Controlled Trial. All the patients recruited undergo baseline cognitive assessment (T0). Patients who meet the inclusion and exclusion criteria are enrolled and randomly assigned to the experimental group (CoRe software) or control group (paper-and-pencil CoRe version). CT program consists of 12 individual sessions (3 sessions/week) each lasting 45 minutes of computer-based or paper-and-pencil logical-executive and working-memory tasks.
All the patients are evaluated at the end of the 3-weeks training (T1), to detect the training effect, and six month (T2) and one year (T3) after the end of CT to assess the persistence of the training-related improvement and also to evaluate the impact of CT on the evolution of cognitive decline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel assignment, prospective, double-blind, randomized, controlled study
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Control GroupA computer-supported cognitive training for the training of logical-executive and working-memory functions (CoRe software) |
| Control Group | Other | Other: CoRe softwarePaper and pencil cognitive training (paper-and-pencil CoRe version) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoRe softwareComputer-supported cognitive training (CT) | Other | Control Group |
| Control GroupPaper and pencil cognitive training (paper-and-pencil CoRe version) | Other | Experimental group |
Primary outcome
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.
5 secondary outcomes
Change in Memory
Time frame: after 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Background: PubMed 22908189Mayeux R, Stern Y. Epidemiology of Alzheimer disease. Cold Spring Harb Perspect Med. 2012 Aug 1;2(8):a006239. doi: 10.1101/cshperspect.a006239.
- Background: PubMed 17958927Belleville 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.
- Background: PubMed 20220584Jean 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.
- Background: PubMed 24715864Robert 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.
- Background: PubMed 27899737Walton 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.
- Background: PubMed 24998488Coyle 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.
- Background: PubMed 31256092Bernini 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.
- Background: PubMed 29779721Alloni 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.
- Background: PubMed 26505323Alloni 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.
- Derived from this study: PubMed 32895890Bernini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Sinforiani, MD principal investigator
IRCCS Mondino Foundation, Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoRe software in people with Mild Cognitive Impairment, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cinzia Fattore, MD (0039 0382 380385, cinzia.fattore@mondino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04111640, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.