Personalized Computerized Training Program for Cognitive Dysfunction After COVID-19

October 5, 2022 updated by: Jon Andoni Duñabeitia, Universidad Antonio de Nebrija

Before-and-after Study on the Impact of a Home-based Personalized Computerized Training Program on Cognitive Dysfunction Associated With Long COVID

This before-and-after study aims to evaluate the usefulness and efficacy of a personalized computerized cognitive training (CCT) to improve cognitive function among people with post-acute sequelae of COVID-19 (PASC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Through an online platform created for the study, adults who self-reported cognitive impairment more than 3 months after receiving a COVID-19 diagnosis will be enlisted and their cognitive status will be assessed using a commercially available test. After determining their level of general cognitive dysfunction, those who qualify and meet the inclusion criteria will be invited to use a customized computerized cognitive training (CCT) program at home and to complete as many daily training sessions as they would want over the course of eight weeks. The sessions will consist of gamified cognitively demanding exercises that target five cognitive skills: attention, coordination, memory, perception, and reasoning. Participants will also complete the general cognitive function assessment at the end of the intervention period, and the differences between the cognitive scores obtained before and after this period will be used as the main outcome measure. Additional analysis will be performed to better characterize the impact of the CCT by exploring the role of the age of the participants, their self-perceive health at baseline, the intensity of the training and the time from initial COVID-19 infection.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Universidad Nebrija

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults (older than 18 years old).
  • History of infection with COVID-19 at least 3 months prior to expression of interest.
  • Presence of self-perceived cognitive dysfunction associated with PACS (concentration problems or brain fog).

Exclusion Criteria:

  • Completion of less than 10 training sessions.
  • Not completing the final evaluation after the 8-week training period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Computerized Cognitive Training
Participants will be asked to complete short sessions of around 10 minutes each consisting of a variety of games designed to train the five cognitive skills (attention, memory, coordination, reasoning and perception). Each training session include two games selected among a pool of 12 different games. Participants will be asked to complete a training lasting for 8 weeks in which they could access the training platform as frequently as they wanted.
Device: CogniFit's CCT Post COVID-19
The computerized cognitive training (CCT) program is tailored to each person's specific cognitive strengths and weaknesses detected in the Cognitive Assessment Battery (CAB)™ PRO (CogniFit Inc., San Francisco, US; https://www.cognifit.com/cab) by a patented Individualized Training System™ (ITS) software.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Gains
Time Frame: 8 weeks
The difference in scores between the initial and final assessments as evaluated by the Cognitive Assessment Battery (CAB)™ PRO
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of the training
Time Frame: 8 weeks
Number of minutes dedicated to the CCT
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Antonio de Nebrija

Investigators

  • Principal Investigator: Jon Andoni Duñabeitia, Universidad Nebrija

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

October 3, 2022

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 5, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UANebrija

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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