Personalized Computerized Training Program for Cognitive Dysfunction After COVID-19

Long COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05571852
• Other study ID #: UANebrija
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: October 2022
• Source: Universidad Antonio de Nebrija
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• COVID-19
• Long COVID

Intervention

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.

Locations

Country	Name	City	State
Spain	Universidad Nebrija	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Antonio de Nebrija

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Gains	The difference in scores between the initial and final assessments as evaluated by the Cognitive Assessment Battery (CAB)™ PRO	8 weeks
Secondary	Intensity of the training	Number of minutes dedicated to the CCT	8 weeks