Post-Acute COVID-19NCT05571852
Personalized Computerized Training Program for Cognitive Dysfunction After COVID-19
A study testing CogniFit's CCT Post COVID-19 in people with Post-Acute COVID-19 and Long COVID, run by Universidad Antonio de Nebrija at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Acute COVID-19, Long COVID
- What is being tested?
- CogniFit's CCT Post COVID-19
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Completion of less than 10 training sessions.
- Not completing the final evaluation after the 8-week training period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Being tested
- CogniFit's CCT Post COVID-19
- Keywords
- Long COVID, Computerized Cognitive Training, Post-Acute Sequeale of COVID-19, Cognitive Dysfunction, Brain Fog
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Cognitive Dysfunction, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CogniFit's CCT Post COVID-19Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Computerized Cognitive Training | Experimental | 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. Receives: Device: CogniFit's CCT Post COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Gains
The difference in scores between the initial and final assessments as evaluated by the Cognitive Assessment Battery (CAB)™ PRO
Measured: 8 weeks
Secondary outcomes (1)
Intensity of the training
Number of minutes dedicated to the CCT
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 Dec 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Acute COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Antonio de Nebrija
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon Andoni Duñabeitia, Universidad Antonio de Nebrija
- Investigators
- Jon Andoni Duñabeitia, Principal investigator, Universidad Nebrija
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571852
- Sponsor's protocol ID
- UANebrija
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36833793
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Before-and-after Study on the Impact of a Home-based Personalized Computerized Training Program on Cognitive Dysfunction Associated With Long COVID
- ClinicalTrials.gov ID
- NCT05571852
- Acronym / sponsor ID
- UANebrija
- Conditions
- Post-Acute COVID-19, Long COVID
- Keywords
- Long COVID, Computerized Cognitive Training, Post-Acute Sequeale of COVID-19, Cognitive Dysfunction, Brain Fog
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Universidad Antonio de NebrijaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computerized Cognitive Training | Experimental | Device: CogniFit's CCT Post COVID-19Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Completion of less than 10 training sessions.
- Not completing the final evaluation after the 8-week training period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CogniFit's CCT Post COVID-19The 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. | Device | Computerized Cognitive Training |
Primary outcome
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
1 secondary outcome
Intensity of the training
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Derived from this study: PubMed 36833793Dunabeitia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Andoni Duñabeitia principal investigator
Universidad Nebrija
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CogniFit's CCT Post COVID-19 in people with Post-Acute COVID-19 and Long COVID, run by Universidad Antonio de Nebrija at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Gains (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05571852, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.