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Personalized Computerized Training Program for Cognitive Dysfunction After COVID-19

Primary Purpose

Post-Acute COVID-19, Long COVID

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
CogniFit's CCT Post COVID-19
Sponsored by
Universidad Antonio de Nebrija
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Acute COVID-19 focused on measuring Long COVID, Computerized Cognitive Training, Post-Acute Sequeale of COVID-19, Cognitive Dysfunction, Brain Fog

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidad Nebrija

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Computerized Cognitive Training

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Intensity of the training
Number of minutes dedicated to the CCT

Full Information

First Posted
October 3, 2022
Last Updated
October 5, 2022
Sponsor
Universidad Antonio de Nebrija
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1. Study Identification

Unique Protocol Identification Number
NCT05571852
Brief Title
Personalized Computerized Training Program for Cognitive Dysfunction After COVID-19
Official Title
Before-and-after Study on the Impact of a Home-based Personalized Computerized Training Program on Cognitive Dysfunction Associated With Long COVID
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Antonio de Nebrija

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Acute COVID-19, Long COVID
Keywords
Long COVID, Computerized Cognitive Training, Post-Acute Sequeale of COVID-19, Cognitive Dysfunction, Brain Fog

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computerized Cognitive Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CogniFit's CCT Post COVID-19
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive Gains
Description
The difference in scores between the initial and final assessments as evaluated by the Cognitive Assessment Battery (CAB)™ PRO
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Intensity of the training
Description
Number of minutes dedicated to the CCT
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Andoni Duñabeitia
Organizational Affiliation
Universidad Nebrija
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Nebrija
City
Madrid
Country
Spain

12. IPD Sharing Statement

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Personalized Computerized Training Program for Cognitive Dysfunction After COVID-19

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