Clinical trial NCT05338749: Computer Cognitive Training for Post-acute COVID-19 Syndrome
Official title: An Open-label Trial of Computer-delivered Cognitive Training in Persons With Post-acute COVID-19 Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corona Virus Infection
Cognitive Dysfunction
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Technology Acceptance Model Questionnaire, Usefulness subscale
timeFrame: Three weeks
Secondary outcomes:
measure: Cognitive Failures Questionnaire
timeFrame: Three weeks
measure: Trail Making Test, Part B
timeFrame: Three weeks
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Center for Collaborative Research, Nova Southeastern University
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: Raymond L Ownby, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.