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

NCT06399978 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-05-06

No results posted yet for this study

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

Interventions

BEHAVIORAL

Brain Blossom - Gamified Differential Outcome Training

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

BEHAVIORAL

Gamified Non-Differential Outcome Training

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

Sponsors & Collaborators

  • Brain+ ApS

    collaborator UNKNOWN
  • Eurostars EUREKA

    collaborator UNKNOWN
  • Innovation Fund Denmark

    collaborator INDIV
  • University of Aarhus

    collaborator OTHER
  • Pernille Louise Kjeldsen

    lead OTHER

Principal Investigators

  • Jakob U Blicher, Professor · Aalborg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-06
Primary Completion
2024-12-31
Completion
2025-01-31

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06399978 on ClinicalTrials.gov