Personalized Computerized Training Program for Cognitive Dysfunction After COVID-19

NCT ID: NCT05571852

Last Updated: 2022-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-02-28

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).

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.

Conditions

Post-Acute COVID-19; Long COVID

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CogniFit's CCT Post COVID-19

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Antonio de Nebrija

OTHER

Sponsor Role: lead

Responsible Party

Jon Andoni Duñabeitia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jon Andoni Duñabeitia

Role: PRINCIPAL_INVESTIGATOR

Universidad Nebrija

Locations

Universidad Nebrija

Madrid, , Spain

Countries

Spain

References

Dunabeitia JA, Mera F, Baro O, Jadad-Garcia T, Jadad AR. Personalized Computerized Training for Cognitive Dysfunction after COVID-19: A Before-and-After Feasibility Pilot Study. Int J Environ Res Public Health. 2023 Feb 10;20(4):3100. doi: 10.3390/ijerph20043100.

Reference Type: DERIVED

PMID: 36833793 (View on PubMed)

Other Identifiers

UANebrija

Identifier Type: -

Identifier Source: org_study_id