Ignite Creation Date:
2024-05-11 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399978
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-03-20
Brief Title:
The Feasibility and Effect of Digital Cognitive Training in Mild Cognitive Impairment
Sponsor:
Pernille Louise Kjeldsen
Organization:
Aalborg University Hospital
Study Overview
Official Title:
The Feasibility and Effect of Cognitive Training on Objective and Subjective Cognitive Functioning in Patients With Mild Cognitive Impairment A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to assess the feasibility and effect of digital cognitive training based on the principles of Differential Outcome Training DOT in patients with Mild Cognitive Impairment In DOT training each stimulus-response pair to be learnt is followed by a unique reinforcer as opposed to non-DOT NDOT training where the stimulus-response pairs are all followed by a random reinforcer DOT training is believed to boost learning more than NDOT training through associations
The main questions the study aims to answer are
Whether at-home tablet-based digital cognitive training is feasible in elderly patients with Mild Cognitive Impairment
Whether regularly digital cognitive DOT training has a positive effect on patients cognitive functioning and quality of life
Whether any potential effects that the cognitive DOT training may have on the patients cognitive functioning are transferable to the patients daily life
Participation in the study includes
A pre-training session at the site with the primary project coordinator where the patient will complete a number of self-report questionnaires about their health cognition and quality of life as well as a neuropsychological assessment
Training with the digital cognitive DOT training program at home for 20 min per day 3-4 times a week for 6-8 weeks
A post-training session at the site with the primary project coordinator after the 6-8 weeks have passed where the patient will complete a usability questionnaire about the training programme some of the same self-report questionnaires about their health cognition and quality of life as well as some of the neuropsychological assessments
A 1-month follow-up session where the patients will complete some of the same self-report questionnaires again about their cognition and quality of life plus a questionnaire aimed the transferability of any positive cognitive effects of the training
The main questions the study aims to answer are
Whether at-home tablet-based digital cognitive training is feasible in elderly patients with Mild Cognitive Impairment
Whether regularly digital cognitive DOT training has a positive effect on patients cognitive functioning and quality of life
Whether any potential effects that the cognitive DOT training may have on the patients cognitive functioning are transferable to the patients daily life
Participation in the study includes
A pre-training session at the site with the primary project coordinator where the patient will complete a number of self-report questionnaires about their health cognition and quality of life as well as a neuropsychological assessment
Training with the digital cognitive DOT training program at home for 20 min per day 3-4 times a week for 6-8 weeks
A post-training session at the site with the primary project coordinator after the 6-8 weeks have passed where the patient will complete a usability questionnaire about the training programme some of the same self-report questionnaires about their health cognition and quality of life as well as some of the neuropsychological assessments
A 1-month follow-up session where the patients will complete some of the same self-report questionnaires again about their cognition and quality of life plus a questionnaire aimed the transferability of any positive cognitive effects of the training
Detailed Description:
Alzheimers disease AD is the most common form of dementia a debilitating neurodegenerative disease with cognitive impairments especially impairments in memory at its core AD is progressive with cognitive symptoms gradually worsening as AD brain pathology builds over time The clinical construct of Mild Cognitive Impairment MCI represents an intermediate stage between healthy ageing and early dementia with cognitive impairment that is worse than what is seen in healthy ageing but not enough to interfere with daily living Although not all MCI cases lead to dementia the majority of cases eventually progress
The amnestic subtype of MCI which is especially characterised by the presence of memory impairments is the most likely to progress to AD dementia In line with the evolution of brain neurodegeneration in AD typically beginning in memory-related medial-temporal limbic areas which specifically contribute to forming and accessing spatial contextual short-term memories spatial memory deficits are especially common in amnestic MCI AD patients and even amnestic MCI patients perform worse on visuospatial short-term memory tasks compared to healthy participants and individuals with other neurodegenerative disorders Memory functions are essential for daily living and memory impairments have been shown to be a major determinant of health outcomes and well-being in age-related disorders
At the time an MCI diagnosis is made the pathological burden is often so high that it is almost impossible to stop or reverse the cognitive impairment Presently there is no cure for AD or any other type of dementia and available pharmacological treatments have only very limited effects on cognitive symptoms A major research priority should therefore be to develop non-pharmacological approaches which are cost-effective and potentially feasible for large-scale implementation to preserve and promote cognitive function and improve quality of life early on in MCI
Previous studies have shown beneficial effects of cognitive training in MCI and AD patients using a novel training procedure that has been proposed to active and relay on memory processes and brain structures that are less affected in MCI and AD - The Differential Outcome Training DOT DOT training is based on the principle that each stimulus-response association to be learned is followed by a unique reinforcer relative to a condition where reinforcers are presented randomly non-differential outcomes training NDOT DOT training has been shown to result in enhanced learning including faster acquisition better overall retention and higher retention accuracy in both animals and humans Nonetheless the effects of a prolonged DOT training on visuospatial short-term memory performance and possible transfer of any benefits to other memory tasks and cognitive domains as well as its impact on quality of life in patients with MCI requires further research
This study aims to establish the feasibility and effectiveness of a recently developed digital gamified type of cognitive training in individuals with MCI The study aims to address this by using a recently developed gamified version of the DOT task This gamified DOT task integrates the DOT procedure within a gardening task Participants are introduced to a botanic garden that they have to keep up which includes cleaning up obtaining seeds planting plants and putting up decorations They can obtain seeds plants and money by performing a visuospatial short-term memory DOT task which they can then use for the garden
The purpose of this study is threefold 1 to assess if digital gamified cognitive training at home is feasible in elderly patients with MCI 2 to explore the effectiveness of the gamified version of the DOT task on MCI patients cognitive functioning and quality of life and 3 to explore any possible transfer benefits of the DOT training to other cognitive tasks and to individuals self-report measures of quality of life
For this study 40 MCI patients aged 65-80 will be recruited from the local Dementia Clinic The patients will be randomly assigned to an intervention group gamified DOT group N20 and an active control group gamified NDOT N20 The patients will meet with the project coordinator for a pre-training session to assess their cognitive functioning and wellbeing prior to the cognitive training after which they will complete 6-8 weeks of training at home and will upon completion of the training come back in for a post-training session to assess whether the patients found the cognitive training feasible and whether the training has had an effect on the patients cognitive functioning and wellbeing
The study follows the Helsinki Declaration and will not begin before the necessary ethical and other approvals have been obtained Laws and guidelines regarding handling personal data GDPR rules will also be followed with regards to all parts of the study
The amnestic subtype of MCI which is especially characterised by the presence of memory impairments is the most likely to progress to AD dementia In line with the evolution of brain neurodegeneration in AD typically beginning in memory-related medial-temporal limbic areas which specifically contribute to forming and accessing spatial contextual short-term memories spatial memory deficits are especially common in amnestic MCI AD patients and even amnestic MCI patients perform worse on visuospatial short-term memory tasks compared to healthy participants and individuals with other neurodegenerative disorders Memory functions are essential for daily living and memory impairments have been shown to be a major determinant of health outcomes and well-being in age-related disorders
At the time an MCI diagnosis is made the pathological burden is often so high that it is almost impossible to stop or reverse the cognitive impairment Presently there is no cure for AD or any other type of dementia and available pharmacological treatments have only very limited effects on cognitive symptoms A major research priority should therefore be to develop non-pharmacological approaches which are cost-effective and potentially feasible for large-scale implementation to preserve and promote cognitive function and improve quality of life early on in MCI
Previous studies have shown beneficial effects of cognitive training in MCI and AD patients using a novel training procedure that has been proposed to active and relay on memory processes and brain structures that are less affected in MCI and AD - The Differential Outcome Training DOT DOT training is based on the principle that each stimulus-response association to be learned is followed by a unique reinforcer relative to a condition where reinforcers are presented randomly non-differential outcomes training NDOT DOT training has been shown to result in enhanced learning including faster acquisition better overall retention and higher retention accuracy in both animals and humans Nonetheless the effects of a prolonged DOT training on visuospatial short-term memory performance and possible transfer of any benefits to other memory tasks and cognitive domains as well as its impact on quality of life in patients with MCI requires further research
This study aims to establish the feasibility and effectiveness of a recently developed digital gamified type of cognitive training in individuals with MCI The study aims to address this by using a recently developed gamified version of the DOT task This gamified DOT task integrates the DOT procedure within a gardening task Participants are introduced to a botanic garden that they have to keep up which includes cleaning up obtaining seeds planting plants and putting up decorations They can obtain seeds plants and money by performing a visuospatial short-term memory DOT task which they can then use for the garden
The purpose of this study is threefold 1 to assess if digital gamified cognitive training at home is feasible in elderly patients with MCI 2 to explore the effectiveness of the gamified version of the DOT task on MCI patients cognitive functioning and quality of life and 3 to explore any possible transfer benefits of the DOT training to other cognitive tasks and to individuals self-report measures of quality of life
For this study 40 MCI patients aged 65-80 will be recruited from the local Dementia Clinic The patients will be randomly assigned to an intervention group gamified DOT group N20 and an active control group gamified NDOT N20 The patients will meet with the project coordinator for a pre-training session to assess their cognitive functioning and wellbeing prior to the cognitive training after which they will complete 6-8 weeks of training at home and will upon completion of the training come back in for a post-training session to assess whether the patients found the cognitive training feasible and whether the training has had an effect on the patients cognitive functioning and wellbeing
The study follows the Helsinki Declaration and will not begin before the necessary ethical and other approvals have been obtained Laws and guidelines regarding handling personal data GDPR rules will also be followed with regards to all parts of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None