Corona Virus InfectionPACS-CogNCT05338749
Computer Cognitive Training for Post-acute COVID-19 Syndrome
A study testing Cognitive Training in people with Corona Virus Infection and Cognitive Dysfunction, run by Nova Southeastern University at 1 site in United States.
Trial summary
This study will assess the acceptability, feasibility, and impact of game-based computer-delivered cognitive training on cognitive function in persons with cognitive symptoms that persist after recovery from acute coronavirus-19 (COVID) infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corona Virus Infection, Cognitive Dysfunction
- What is being tested?
- Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2022to 30 Nov 2023
- 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
- Persons with a history of COVID-19 infection confirmed through screening of symptom pattern or testing and report of mental symptoms (difficulties in attention, memory, or executive functions such as coordinating two activities at once) more than 30 days after resolution of the initial acute infection.
Who cannot join
- Cognitive or psychiatric conditions of a severity that precludes the person's ability to give informed consent for their participation or to attend and cooperate with assessment and training, as judged by the investigators.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Collaborative Research, Nova Southeastern University
Fort Lauderdale, Florida, 33314
About this study
Official title: An Open-label Trial of Computer-delivered Cognitive Training in Persons With Post-acute COVID-19 Syndrome
This study will assess the acceptability, feasibility, and impact of game-based computer-delivered cognitive training on cognitive function in persons with cognitive symptoms that persist after recovery from acute coronavirus-19 (COVID) infection.
Read the detailed description
Over the course of the past several years, it has become apparent that a number of individuals have residual symptoms after COVID-19 infection after they have recovered from the acute phase of the illness (Al-Aly, Xie, \& Bowe, 2021; Davis et al., 2021; Greenhalgh, Knight, A'Court, Buxton, \& Husain, 2020; Hewitt et al., 2021). The constellation of symptoms experienced by these individuals has been termed "post-acute COVID syndrome" or PACS (Nalbandian et al., 2021). A key part of helping affected individuals is supporting their efforts at self-management of these symptoms (National Institute for Health and Care Excellence, 2020; Wade, 2020). Although a diverse number of physical and psychological symptoms have been seen as sequelae of COVID (Davis et al., 2021), among the most troubling for patients have been difficulties in attention, concentration, working memory, and long-term memory, commonly referred to as "brain fog" (Graham et al., 2021; Hampshire et al., 2021; Hewitt et al., 2021). In the proposed study, we will complete a pilot study of game-based cognitive training in persons with symptoms of long COVID using a protocol that was useful and acceptable to participants in a previous study (Ownby \& Kim, 2021). We will explore participants' views on the cognitive training intervention, its effects on their perceived cognitive functioning, and assess the intervention's impact on participants' processing speed. We will also explore their preferences for type of cognitive training activity and the impact of information about memory functioning.
- Conditions
- Corona Virus Infection, Cognitive Dysfunction
- Being tested
- Cognitive Training
- Medical subject headings
- Coronavirus Infections, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
Gamified cognitive training intervention to improve mental speed and attention.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | Participants in this condition will received game-based cognitive training. Receives: Behavioral: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technology Acceptance Model Questionnaire, Usefulness subscale
User self-report of their perception that an application serves a function that may be helpful The score is the average of several items rated by the user from 0 to 6, so that the final score itself can range from 0 to 6. Higher scores indicate that the user found the intervention more useful. Higher scores are better.
Measured: Three weeks
Secondary outcomes (2)
Cognitive Failures Questionnaire
A standard self-report measure of problems in memory, attention, and self-regulated behavior. This measures includes self-report ratings on 25 items, with ratings ranging from 0 to 4. The total score can thus range from 0 to 100, with higher scores indicating that the person experiences more problems with thinking and remembering.
Measured: Three weeks
Trail Making Test, Part B
This is a measure of how rapidly a person can remember alternating sequences of numbers and letters while connecting them on a paper with a pencil. The score is time in seconds to complete the task, with the provision that if a person cannot finish the task within three minutes, the task is discontinued and the person is assigned a score of 180 (for 3 minutes times 60 seconds). Lower scores indicate better performance.
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start26 Apr 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
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 Corona Virus InfectionStudies 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
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raymond L Ownby, MD, PhD, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338749
- Sponsor's protocol ID
- 20211020
- Acronym
- PACS-Cog
- Status last verified
- Mar 2024
- First submitted
- 14 Apr 2022
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing plan
Publications
Ownby RL, Kim J. Computer-Delivered Cognitive Training and Transcranial Direct Current Stimulation in Patients With HIV-Associated Neurocognitive Disorder: A Randomized Trial. Front Aging Neurosci. 2021 Nov 15;13:766311. doi: 10.3389/fnagi.2021.766311. eCollection 2021.
PubMed 34867291
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Trial of Computer-delivered Cognitive Training in Persons With Post-acute COVID-19 Syndrome
- ClinicalTrials.gov ID
- NCT05338749
- Acronym / sponsor ID
- PACS-Cog / 20211020
- Conditions
- Corona Virus Infection, Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 21 Apr 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 study will assess the acceptability, feasibility, and impact of game-based computer-delivered cognitive training on cognitive function in persons with cognitive symptoms that persist after recovery from acute coronavirus-19 (COVID) infection.
Detailed description
Over the course of the past several years, it has become apparent that a number of individuals have residual symptoms after COVID-19 infection after they have recovered from the acute phase of the illness (Al-Aly, Xie, \& Bowe, 2021; Davis et al., 2021; Greenhalgh, Knight, A'Court, Buxton, \& Husain, 2020; Hewitt et al., 2021). The constellation of symptoms experienced by these individuals has been termed "post-acute COVID syndrome" or PACS (Nalbandian et al., 2021). A key part of helping affected individuals is supporting their efforts at self-management of these symptoms (National Institute for Health and Care Excellence, 2020; Wade, 2020). Although a diverse number of physical and psychological symptoms have been seen as sequelae of COVID (Davis et al., 2021), among the most troubling for patients have been difficulties in attention, concentration, working memory, and long-term memory, commonly referred to as "brain fog" (Graham et al., 2021; Hampshire et al., 2021; Hewitt et al., 2021). In the proposed study, we will complete a pilot study of game-based cognitive training in persons with symptoms of long COVID using a protocol that was useful and acceptable to participants in a previous study (Ownby \& Kim, 2021). We will explore participants' views on the cognitive training intervention, its effects on their perceived cognitive functioning, and assess the intervention's impact on participants' processing speed. We will also explore their preferences for type of cognitive training activity and the impact of information about memory functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: Cognitive TrainingParticipants in this condition will received game-based cognitive training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persons with a history of COVID-19 infection confirmed through screening of symptom pattern or testing and report of mental symptoms (difficulties in attention, memory, or executive functions such as coordinating two activities at once) more than 30 days after resolution of the initial acute infection.
Key exclusion criteria (1 listed)
- Cognitive or psychiatric conditions of a severity that precludes the person's ability to give informed consent for their participation or to attend and cooperate with assessment and training, as judged by the investigators.
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 |
|---|---|---|
| Cognitive TrainingGamified cognitive training intervention to improve mental speed and attention. | Behavioural | Cognitive Training |
Primary outcome
Technology Acceptance Model Questionnaire, Usefulness subscale
Time frame: Three weeks
User self-report of their perception that an application serves a function that may be helpful The score is the average of several items rated by the user from 0 to 6, so that the final score itself can range from 0 to 6. Higher scores indicate that the user found the intervention more useful. Higher scores are better.
2 secondary outcomes
Cognitive Failures Questionnaire
Time frame: Three weeks
Trail Making Test, Part B
Time frame: Three 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 29 Mar 2024.
- Background: PubMed 34867291Ownby RL, Kim J. Computer-Delivered Cognitive Training and Transcranial Direct Current Stimulation in Patients With HIV-Associated Neurocognitive Disorder: A Randomized Trial. Front Aging Neurosci. 2021 Nov 15;13:766311. doi: 10.3389/fnagi.2021.766311. eCollection 2021.
- Individual participant dataSharing planned: Yes. Data sharing plan
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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.
Raymond L Ownby, MD, PhD principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training in people with Corona Virus Infection and Cognitive Dysfunction, run by Nova Southeastern University at 1 site in United States.
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 1 inclusion and 1 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 29 Mar 2024. 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 United States. 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?
Technology Acceptance Model Questionnaire, Usefulness subscale (time frame: Three 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 NCT05338749, 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 29 Mar 2024.