Clinical trial NCT07005921: Attention, Memory and Quality of Life in Post-COVID-19 Adults
Official title: Attention, Memory, Self-reflection and Insight, and Quality of Life in Post-COVID-19 Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-Acute COVID-19 Syndrome
Long COVID
Brain Fog
Keywords: Attention
Memory
Self-awareness
COVID-19
COVID-19 syndrome
long COVID
post-COVID-19
Quality of life
Brain Fog
Lead sponsor: Santos Dumont Institute
Sponsor class: OTHER
Collaborators: name: Santos Dumont Institute
First posted: 2025-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The pandemic has highlighted social, economic, educational, and political issues that have affected the health and quality of life of millions of Brazilians. Currently, attention and memory impairment remains predominant among the cognitive symptoms of Coronavirus observed in adults. The persistance of the reffered impairment after 12 weeks of COVID-19 is known as cognitive impairment in post-COVID-19 syndrome. Despite studies indicating the negative effects of COVID-19 on attention and memory, there is a gap in the literature regarding its effects on self-reflection and insight. Previous studies highlight the role of self-awareness as an essential cognitive process that aids the criation of a resolution for the social consequences of the ongoing pandemic. Thus, understanding the relationship between self-reflection, insight, memory, and quality of life in adults that presented COVID-19 could reveal how memory loss might affect the ability to evaluate and understand one's own behaviors and quality of life. Moreover, this study could provide a background for future interventions to enhance attention, memory, self-reflection, and insight in this population. In this context, quantitative electroencephalogram neurofeedback training (EEGq-NFT) is a promising non-invasive intervention designed to improve cognition, such as attention and working memory. By modifying electrophysiological patterns in the cerebral cortex. Considering the information presented, the question is what is the relationship between cognitive failures, self-reflection and insight, and quality of life in adults who had COVID-19, and what is the efficacy of EEGq-NFT training in rehabilitating attention and working memory in adults with cognitive impairment due to post-COVID-19 syndrome. This study aims to examine the relationship between cognitive failures, self-reflection, insight, and quality of life in adults post-COVID-19, as well as to assess the efficacy of EEGq-NFT in improving attention and working memory in adults with cognitive impairment due to post-COVID-19 syndrome. Method 1 will employ a survey with cross-sectional design and quantitative data analysis. A total of 385 adults will be recruted. Data will be collected through online forms. Cognitive Failures Questionnaire, Self-Reflection and Insight Scale and WHOQOL-bref scale will be used. In Method 2, a quasi-experimental with quantitative data analysis will be employed. A total of 60 participants will be randomly assigned to an EEGq neurofeedback training group (n = 20), an active control group called SHAM EEGq-neurofeedback (n = 20), and a waiting list control group (n = 20). The theta/beta ratio reduction protocol at Cz will be used, with 10 sessions of 30 minutes each. The Psychological Battery of Attention 2 (BPA-2) and Digit Span Test will be employed to measure attention and working memory levels. Statistical analyses will be performed using IBM SPSS version 25 with statistical significance set at p \< 0.05 for a 95% confidence interval. The research follows all ethical standards for studies involving human subjects and was submitted for review and approval at the Research Ethics Committee. A understanding of memory levels, self-reflection, insight, and quality of life in adults post- COVID-19 is expected as a result of the present study. Additionally, this study expects that EEGq-NFT will be effective in reducing the theta/beta ratio, as well as improving attention and working memory in adults with cognitive impairment in post-COVID-19 syndrome.


Eligibility criteria: The inclusion criteria - 1) Be over 18 years old and under 60 years old, 2) Authorize participation in the study through the informed consent form.

The exclusion criteria - 1) Be under 18 years old and over 60 years old; 2) Discontinue participation in the study, 3) Use psychoactive substances that affect attention and memory, 4) Present physical or cognitive repercussions resulting from other diagnoses prior to or subsequent to COVID-19, 5) Present a history of attention and memory impairment prior to the diagnosis of COVID-19.

Primary outcomes:
measure: Change from Baseline in the Mean of Psychological Battery of Attention 2 (BPA-2), Digit Span Test, and Five Digit Test at 5 weeks
timeFrame: From baseline to the end of treatment at 5 weeks. Finally, at follow-up 30 days post treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Macaíba
country: Brazil
facility: Santos Dumont Institute
state: RN
Study officials:
References: