The Feasibility and Effect of Digital Cognitive Training in Mild Cognitive Impairment - Trial NCT06399978
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Study Focus
Brain Blossom - Gamified Differential Outcome Training
Interventional
behavioral
Sponsor & Location
Pernille Louise Kjeldsen
Aalborg University Hospital
Timeline & Enrollment
N/A
May 06, 2024
Jan 31, 2025
Primary Outcome
Usability of the digital cognitive training program assessed with a self-report questionnaire,Memory task performance assessed with a Differential Outcome Task (DOT task),Visuo-spatial memory task performance assessed with a gamified visuo-spatial memory task (Starry Night),Subjective cognitive functioning assessed by the 20-Item Short-Form Change in Cognition Scale (CCI-S-20),Quality of life assessed with the Quality of Life Ladder (QoL Ladder),Depressive symptoms assessed with the 15-Item Geriatric Depression Scale (GDS-15)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06399978
Non-Device Trial