Attention, Memory and Quality of Life in Post-COVID-19 Adults

NCT07005921 | Not Yet Recruiting

• 1 other identifier: 7.593.695
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the Mean of Psychological Battery of Attention 2 (BPA-2), Digit Span Test, and Five Digit Test at 5 weeks

  Psychological Battery for Attention Assessment 2 (BPA-2) evaluates overall attention capacity, which is a somatory of specific types of attention, namely, concentrated attention (CA), divided attention (DA) and alternating attention (AA). Digit Span Test (DST) assesses auditory memory and working memory (in direct and reverse order). It consists on sequences of digits, which increase in length, ranging from two to nine items in sequence that must be repeated. The Five Digit Test measures Executive Functions. It involves routines of reading and number counting, with four tasks: reading digits from 1 to 5; counting quantities from 1 to 5; the ability to ignore an automatic processing routine (digit reading) in favor of a controlled one (digit counting) in incongruent stimuli; and the ability to alternate between reading and counting processes. Participants will achieve a response if they score a performance status of to 3 on a classification ranging from 1 (inferior) to 5 (superior).

  From baseline to the end of treatment at 5 weeks. Finally, at follow-up 30 days post treatment.

Study Arms (3)

qEEG-neurofeedback

EXPERIMENTAL

The participants will be submitted to a qEEG-neurofeedback intervention in order to verifify its feasibility to enhance cognition. The theta/beta ratio reduction protocol at electrodes Fp1, Fp2, Fz, F3, F4, Cz, C3, C4 will be performed, with 10 sessions of qEEG-neurofeedback training, 2 sessions for pre and post test, and 1 session for follow-up after 30 days of intervention. Each session will last approximately 1 hour. The Psychological Battery of Attention 2 (BPA-2) and Digit Span Test will be employed to measure attention and working memory levels. The Montreal Cognitive Assessment (Moca) will be used for neurological and cognitive assessment.

Behavioral: qEEG-neurofeedback

SHAM qEEG-neurofeedback

SHAM COMPARATOR

Behavioral: SHAM qEEG-neurofeedback

wait list control group

NO INTERVENTION

Interventions

qEEG-neurofeedback BEHAVIORAL

The participants will be submitted to a qEEG-neurofeedback intervention in order to verifify its feasibility to enhance cognition. The theta/beta ratio reduction protocol at electrodes Fp1, Fp2, Fz, F3, F4, Cz, C3, C4 will be performed, with 10 sessions of qEEG-neurofeedback training, 2 sessions for pre and post test, and 1 session for follow-up after 30 days of intervention. Each session will last approximately 1 hour. The Psychological Battery of Attention 2 (BPA-2) and Digit Span Test will be employed to measure attention and working memory levels. The Montreal Cognitive Assessment (Moca) will be used for neurological and cognitive assessment. Participants will receive feedback based on their theta/beta ratio in the frontal and central cortical areas (electrodes Fp1, Fp2, Fz, F3, F4, Cz, C3, C4).

Also known as: Experimental Group, Group 1

qEEG-neurofeedback

SHAM qEEG-neurofeedback BEHAVIORAL

The participant will be submitted to an inactive qEEG-neurofeedback that appears to be the same as a functional procedure or device. Participants will not receive feedback based on their theta/beta ratio in the frontal and central cortical areas (electrodes Fp1, Fp2, Fz, F3, F4, Cz, C3, C4).

Also known as: SHAM, Group 2

SHAM qEEG-neurofeedback

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Jade Carvalho Da Silva: lead
• Santos Dumont Institute: collaborator

Study Sites (1)

Santos Dumont Institute

Macaíba, Rio Grande do Norte, 59.288-899, Brazil

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Mental Fatigue; COVID-19

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatigue; Signs and Symptoms; Behavioral Symptoms; Behavior

Central Study Contacts

JADE DA SILVA, Master's degree

CONTACT

+55(27)99613-0197; jadecarvalhos@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 5, 2025
• Study Start: June 10, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

BR (1)