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轻度认知障碍患者的处理速度(SoP)训练加α-经颅交流电刺激:一项双盲、平行、安慰剂对照试验研究方案

Speed of Processing (SoP) Training Plus α-tACS in People With Mild Cognitive Impairment: A Double Blind, Parallel, Placebo Controlled Trial Study Protocol.

作者信息

Leite Jorge, Gonçalves Óscar F, Carvalho Sandra

机构信息

Portucalense Institute for Human Development-INPP, Portucalense University, Porto, Portugal.

Portuguese Network for the Psychological Neuroscience, Portugal.

出版信息

Front Aging Neurosci. 2022 Jul 14;14:880510. doi: 10.3389/fnagi.2022.880510. eCollection 2022.

Abstract

Several cognitive training programs, alone or in combination with non-invasive brain stimulation have been tested in order to ameliorate age-related cognitive impairments, such as the ones found in Mild Cognitive Impairment (MCI). However, the effects of Cognitive Training (CT)-combined or not-with several forms of non-invasive brain stimulation have been modest at most. We aim to assess if Speed of Processing (SoP) training combined with alpha transcranial alternating current stimulation (α-tACS) is able to increase speed of processing as assessed by the Useful Field of View (UFOV), when comparing to SoP training or active α-tACS alone. Moreover, we want to assess if those changes in speed of processing transfer to other cognitive domains, such as memory, language and executive functioning by using the NIH EXAMINER. We also want to test the mechanisms underlying these interventions, namely brain connectivity and coherence as assessed by electroencephalography (EEG). To that purpose, our proposal is to enroll 327 elders diagnosed with MCI in a double-blinded, parallel randomized clinical trial assessing the effects of combining SoP with alpha endogenous tACS (either active or sham) in people with MCI. Participants will perform an intervention that will last for 15 sessions. For the first 3 weeks, participants will receive nine sessions of the intervention, and then will receive two sessions per week (i.e., booster) for the following 3 weeks. They will then be assessed at 1, 3, and 6 months after the intervention has ended. This will allow us to detect the immediate, and long-term effects of the interventions, as well as to probe the mechanisms underlying its effects. Clinicaltrials.gov, Identifier: NCT05198726.

摘要

为了改善与年龄相关的认知障碍,如轻度认知障碍(MCI)中发现的认知障碍,已经对几种认知训练方案单独或与非侵入性脑刺激相结合进行了测试。然而,认知训练(CT)与几种形式的非侵入性脑刺激相结合或不结合的效果至多是适度的。我们的目的是评估与单独的处理速度(SoP)训练或主动α经颅交流电刺激(α-tACS)相比,处理速度训练与α经颅交流电刺激相结合是否能够提高有用视野(UFOV)评估的处理速度。此外,我们想通过使用美国国立卫生研究院检查仪(NIH EXAMINER)评估这些处理速度的变化是否会转移到其他认知领域,如记忆、语言和执行功能。我们还想测试这些干预措施的潜在机制,即通过脑电图(EEG)评估的脑连接性和相干性。为此,我们的提议是招募327名被诊断为MCI的老年人参加一项双盲、平行随机临床试验,评估在MCI患者中将SoP与α内源性tACS(主动或假刺激)相结合的效果。参与者将进行为期15节的干预。在最初的3周内,参与者将接受9节干预课程,然后在接下来的3周内每周接受2节(即强化)课程。在干预结束后的1、3和6个月对他们进行评估。这将使我们能够检测干预措施的即时和长期效果,以及探究其效果的潜在机制。Clinicaltrials.gov标识符:NCT05198726。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de15/9344129/11873f671cb8/fnagi-14-880510-g0001.jpg

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