Personalized Computerized Training Program for Cognitive Dysfunction After COVID-19

Sponsor
Universidad Antonio de Nebrija (Other)
Overall Status
Completed
CT.gov ID
NCT05571852
Collaborator
(none)
73
1
1
2.9
25

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Device: CogniFit's CCT Post COVID-19
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
73 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Before-and-after Study on the Impact of a Home-based Personalized Computerized Training Program on Cognitive Dysfunction Associated With Long COVID
Actual Study Start Date :
Dec 1, 2021
Actual Primary Completion Date :
Feb 28, 2022
Actual Study Completion Date :
Feb 28, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Cognitive Gains [8 weeks]

    The difference in scores between the initial and final assessments as evaluated by the Cognitive Assessment Battery (CAB)™ PRO

Secondary Outcome Measures

  1. Intensity of the training [8 weeks]

    Number of minutes dedicated to the CCT

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidad Nebrija Madrid Spain

Sponsors and Collaborators

  • Universidad Antonio de Nebrija

Investigators

  • Principal Investigator: Jon Andoni Duñabeitia, Universidad Nebrija

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jon Andoni Duñabeitia, Principal Investigator, Universidad Antonio de Nebrija
ClinicalTrials.gov Identifier:
NCT05571852
Other Study ID Numbers:
  • UANebrija
First Posted:
Oct 7, 2022
Last Update Posted:
Oct 7, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jon Andoni Duñabeitia, Principal Investigator, Universidad Antonio de Nebrija
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 7, 2022