The Feasibility and Effect of Digital Cognitive Training in Mild Cognitive Impairment

NCT06399978 | Not Yet Recruiting

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

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.

Conditions

Mild Cognitive Impairment

Keywords

Mild cognitive impairment; Alzheimer's disease; Cognitive functioning; Quality of life; Digital cognitive training; Gamified cognitive training

Outcome Measures

Primary Outcomes (6)

• Usability of the digital cognitive training program assessed with a self-report questionnaire

  Participants are asked to fill out a self-report questionnaire made specifically for this study. The questionnaire includes 10 questions about the participants' experience with the digital cognitive training post-training, including whether the programme ran smoothly, was easy to use, was engaging, and was fun, and whether the participants would be interested in playing it or similar game again in the future.

  Post-training (6-8 weeks)

• Memory task performance assessed with a Differential Outcome Task (DOT task)

  Participants are asked to complete a computerised face recognition DOT task. Participants are presented with different faces and asked which ones they have seen previously. The responses are each followed by an outcome. There are two versions of the task: a DOT version where each correctly identified face is associated with a certain outcome, and a NDOT version, in which the outcomes appear randomly.

  Post-training (6-8 weeks)

• Visuo-spatial memory task performance assessed with a gamified visuo-spatial memory task (Starry Night)

  Participants are asked to complete the 20-min gamified visuo-spatial memory task, Starry Night. Participants are presented with complex patterns somewhere on a screen for a few seconds at a time. After a short pause, different complex patterns appear on the screen, of which one was the pattern the participant just saw. The participant needs to both choose the correct pattern and then place it on the spot on the screen where it previously appeared.

  Post-training (6-8 weeks)

• Subjective cognitive functioning assessed by the 20-Item Short-Form Change in Cognition Scale (CCI-S-20)

  Participants are asked to fill out the 20-Item Short-Form Change in Cognition Scale (CCI-S-20). This version of the questionnaire contains 20 questions about memory functions in daily life. Participants indicate on a 5-point rating scale if they think their own memory functions are the same as they have always been or if they have become worse, and if so, to which degree. Participants' ratings can be between 0 ('no change in that memory function') to 4 ('severe change in that memory function'). A higher score indicates worse cognition.

  Post-training (6-8 weeks)

• Quality of life assessed with the Quality of Life Ladder (QoL Ladder)

  The Quality of Life Ladder is a commonly used, simple task. Participants are asked to rate their quality of life on a scale from 1 to 8, where 1 is the worst and 8 is the best possible quality of life they could realistically have.

  Post-training (6-8 weeks)

• Depressive symptoms assessed with the 15-Item Geriatric Depression Scale (GDS-15)

  Participants are asked to fill out the 15-Item Geriatric Depression scale (GDS-15). The GDS is a very commonly used measure for depressive symptoms in elderly individuals. The participants are presented with 15 yes- or no-questions. Their responses for each question are coded as either 0 or 1, where 0 indicates that depressive symptoms are not present, while a score of 1 indicates the presence of a depressive symptom. Participants can score between 0 and 15, where a higher score indicates worse mood. A cut-off score of 5 is used, insofar that participants with a score more than five likely have depression.

  Post-training (6-8 weeks)

Secondary Outcomes (3)

• Longterm visuo-spatial memory performance assessed with Starry Night

  1-month follow-up

• Quality of life assessed with the QoL Ladder

  1-month follow-up

• Depressive symptoms assessed with the GDS-15

  1-month follow-up

Study Arms (2)

Gamified DOT

EXPERIMENTAL

Participants perform digital cognitive training with a program based on the Differential Outcomes Training (DOT) principle, in which each stimulus-response association to be learnt is followed by a unique reinforcer/outcome, in order to boost associative learning.

Behavioral: Brain Blossom - Gamified Differential Outcome Training

Gamified non-DOT

ACTIVE COMPARATOR

Participants perform digital cognitive training with a non-Differential Outcomes Training (NDOT) programme, in which each stimulus-response association to be learnt is followed by a random reinforcer/outcome.

Behavioral: Gamified Non-Differential Outcome Training

Interventions

Brain Blossom - Gamified Differential Outcome Training BEHAVIORAL

Digital cognitive training with a gamified DOT task for 20 minutes per day 3-4 times a week for 6-8 weeks.

Also known as: DOT

Gamified DOT

Gamified Non-Differential Outcome Training BEHAVIORAL

Digital cognitive training with a gamified NDOT task for 20 minutes per day 3-4 times a week for 6-8 weeks.

Also known as: NDOT

Gamified non-DOT

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age: 65-80
• MCI diagnosis made by a specialist in a Dementia Clinic:
• Meeting the diagnostic criteria for a diagnosis of MCI
• Abnormal memory function compared to age and education as assessed with a neuropsychological assessment prior to enrolment in the study
• Generally preserved Activities of Daily Living (ADL)
• Not demented
• MCI diagnosis should be made no more than 6 months before enrolment in the study

You may not qualify if:

• Significant systemic disease or unstable medical or psychiatric disorder
• Past history of stroke, brain damage, head trauma, or concussion, which significantly affects level of functioning
• Past history of significant alcohol or drug abuse
• Significantly impaired vision or hearing
• Colour blindness
• Danish as a second language
• Participation in any other clinical studies during project participation

Sponsors & Collaborators

• Pernille Louise Kjeldsen: lead
• Brain+ ApS: collaborator
• Eurostars EUREKA: collaborator
• Innovation Fund Denmark: collaborator
• University of Aarhus: collaborator

Study Sites (1)

Dept. of Neurology, Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Jakob U Blicher, Professor

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pernille L Kjeldsen, MSc, PhD

CONTACT

004520648033; pernille.kjeldsen@rn.dk

Study Design

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

Model Details: In this study, 40 MCI participants will be randomly assigned to either an intervention group (digital cognitive training with a gamified DOT programme, N=20) or an active control group (digital cognitive training with a gamified non-DOT programme, N=20).

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: May 6, 2024
• Study Start: May 6, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)