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

NCT ID: NCT07005921

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-10

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post-Acute COVID-19 Syndrome Long COVID Brain Fog

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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qEEG-neurofeedback

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.

Group Type EXPERIMENTAL

qEEG-neurofeedback

Intervention Type 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).

SHAM qEEG-neurofeedback

Group Type SHAM_COMPARATOR

SHAM qEEG-neurofeedback

Intervention Type 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).

wait list control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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qEEG-neurofeedback

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).

Intervention Type BEHAVIORAL

SHAM qEEG-neurofeedback

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).

Intervention Type BEHAVIORAL

Other Intervention Names

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Experimental Group Group 1 SHAM Group 2

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Santos Dumont Institute

OTHER

Sponsor Role collaborator

Jade Carvalho Da Silva

OTHER

Sponsor Role lead

Responsible Party

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Jade Carvalho Da Silva

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Santos Dumont Institute

Macaíba, Rio Grande do Norte, Brazil

Site Status

Countries

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Brazil

Central Contacts

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JADE DA SILVA, Master's degree

Role: CONTACT

+55(27)99613-0197

Facility Contacts

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Denis Delisle Rodriguez Rodriguez, Phd

Role: primary

+55(27)99969-3552

Other Identifiers

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7.593.695

Identifier Type: -

Identifier Source: org_study_id

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