QEEG-NEUROFEEDBACK FOR COGNITIVE REHABILITATION IN LONG COVID-19 SURVIVORS WITH BRAIN FOG: A Sham-controlled, Double-blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from Baseline in the Mean of Psychological Battery of Attention 2 (BPA-2), Digit Span Test (DST), and Five Digit Test (FDT) at 5 weeks
研究概览
简要总结
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 the investigation of QEEG-neurofeedback training (QEEG-NFT) efficacy for neurocognitive rehabilitation in COVID survivors with brain fog. 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 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 verify the efficacy of EEGq-NFT to rehabilitate cognition, more specifically attention, working memory and speed processing, in adults with cognitive impairment related to post-COVID-19 syndrome. A total of 40 participants were be randomly assigned to an EEGq neurofeedback training group (n = 13), an active control group called SHAM EEGq-neurofeedback (n = 13), and a waiting list control group (n = 14). The theta/beta ratio reduction protocol at frontal and central areas were used, with a total of 13 sessions. The Psychological Battery of Attention 2 (BPA-2), Digit Span Test (DST) and Five Digit Test (FDT) were employed to measure attention, working memory and speed processing levels. Statistical analyses were performed using JASP and R softwares with statistical significance set at p < 0.05 for a 95% confidence interval. The research followed all ethical standards for studies involving human subjects and was submitted for review and approval at the Research Ethics Committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria were: 1) Present a history of positive diagnosis of COVID, 2) Present post-COVID-19 syndrome, as defined by the United Kingdom's National Institute for Health and Care Excellence (NICE), 3) Present a score equal or lower than 26 on the Montreal Cognitive Assessment (MoCA), 4) Be over 18 years old and under 60 years old, 5) Not use psychoactive substances, such as methylphenidate, benzodiazepines and hypnotics, 6) Not have a history of neurological and/or psychiatric diseases prior to or subsequent COVID-19, 7) Authorize participation in the study through the informed consent form. The
排除标准
- •were: 1) Present physical or cognitive repercussions resulting from other diagnoses prior to or subsequent to COVID-19, 2) Discontinue participation in the study, 3) Present a history of attention and memory impairment prior to the diagnosis of COVID-19.
研究组 & 干预措施
wait list control group
SHAM qEEG-neurofeedback
干预措施: SHAM qEEG-neurofeedback (Behavioral)
qEEG-neurofeedback
The participants were 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 were 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. The Psychological Battery of Attention 2 (BPA-2), Digit Span Test (DST) and Five Digit Test (FDT) were employed to measure attention and working memory levels. The Montreal Cognitive Assessment (Moca) were used for neurological and cognitive assessment.
干预措施: qEEG-neurofeedback (Behavioral)
结局指标
主要结局
Change from Baseline in the Mean of Psychological Battery of Attention 2 (BPA-2), Digit Span Test (DST), and Five Digit Test (FDT) at 5 weeks
时间窗: From baseline to the end of treatment at 5 weeks. Finally, at follow-up 30 days post treatment.
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).
Change from Baseline in the Mean of Psychological Battery of Attention 2 (BPA-2), Digit Span Test, and Five Digit Test at 5 weeks
时间窗: From baseline to the end of treatment at 5 weeks. Finally, at follow-up 30 days post treatment.
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).
次要结局
未报告次要终点
研究者
Jade Carvalho Da Silva
Principal Investigator
Santos Dumont Institute