通过基于神经可塑性的计算机化运动改善老年人的神经健康：一项随机对照试验方案

Improving Neurological Health in Aging Via Neuroplasticity-Based Computerized Exercise: Protocol for a Randomized Controlled Trial.

作者信息

Attarha Mouna, de Figueiredo Pelegrino Ana Carolina, Toussaint Paule-Joanne, Grant Sarah-Jane, Van Vleet Thomas, de Villers-Sidani Etienne

机构信息

Posit Science Corporation, San Francisco, CA, United States.

Department of Neurology and Neurosurgery, Montreal Neurological Institute-Hospital, McGill University, Montreal, QC, Canada.

出版信息

JMIR Res Protoc. 2024 Aug 8;13:e59705. doi: 10.2196/59705.

DOI:10.2196/59705

PMID:39116435

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11342015/

Abstract

BACKGROUND

Our current understanding of how computerized brain training drives cognitive and functional benefits remains incomplete. This paper describes the protocol for Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise (INHANCE), a randomized controlled trial in healthy older adults designed to evaluate whether brain training improves cholinergic signaling.

OBJECTIVE

INHANCE evaluates whether 2 computerized training programs alter acetylcholine binding using the vesicular acetylcholine transporter ligand [18F] fluoroethoxybenzovesamicol ([18F] FEOBV) and positron emission tomography (PET).

METHODS

In this phase IIb, prospective, double-blind, parallel-arm, active-controlled randomized trial, a minimum of 92 community-dwelling healthy adults aged 65 years and older are randomly assigned to a brain training program designed using the principles of neuroplasticity (BrainHQ by Posit Science) or to an active control program of computer games designed for entertainment (eg, Solitaire). Both programs consist of 30-minute sessions, 7 times per week for 10 weeks (35 total hours), completed remotely at home using either loaned or personal devices. The primary outcome is the change in FEOBV binding in the anterior cingulate cortex, assessed at baseline and posttest. Exploratory cognitive and behavioral outcomes sensitive to acetylcholine are evaluated before, immediately after, and 3 months following the intervention to assess the maintenance of observed effects.

RESULTS

The trial was funded in September 2019. The study received approval from the Western Institutional Review Board in October 2020 with Research Ethics Board of McGill University Health Centre and Health Canada approvals in June 2021. The trial is currently ongoing. The first participant was enrolled in July 2021, enrollment closed when 93 participants were randomized in December 2023, and the trial will conclude in June 2024. The study team will be unblinded to conduct analyses after the final participant exits the study. We expect to publish the results in the fourth quarter of 2024.

CONCLUSIONS

There remains a critical need to identify effective and scalable nonpharmaceutical interventions to enhance cognition in older adults. This trial contributes to our understanding of brain training by providing a potential neurochemical explanation of cognitive benefit.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04149457; https://clinicaltrials.gov/ct2/show/NCT04149457.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59705.

摘要

背景

我们目前对计算机化大脑训练如何带来认知和功能益处的理解仍不完整。本文描述了通过基于神经可塑性的计算机化锻炼改善老年人神经健康（INHANCE）的试验方案，这是一项针对健康老年人的随机对照试验，旨在评估大脑训练是否能改善胆碱能信号传导。

目的

INHANCE试验旨在评估两个计算机化训练项目是否会使用囊泡乙酰胆碱转运体配体[18F]氟乙氧基苯并维司米可（[18F]FEOBV）和正电子发射断层扫描（PET）来改变乙酰胆碱结合。

方法

在这项IIb期前瞻性、双盲、平行组、活性对照随机试验中，至少92名年龄在65岁及以上的社区居住健康成年人被随机分配到一个使用神经可塑性原理设计的大脑训练项目（Posit Science公司的BrainHQ）或一个为娱乐设计的电脑游戏活性对照项目（如纸牌游戏）。两个项目均由30分钟的课程组成，每周7次，共10周（总计35小时），使用借用或个人设备在家远程完成。主要结局是在前扣带回皮质中FEOBV结合的变化，在基线和测试后进行评估。对乙酰胆碱敏感的探索性认知和行为结局在干预前、干预后立即以及干预后3个月进行评估，以评估观察到的效果的维持情况。

结果

该试验于2019年9月获得资助。该研究于2020年10月获得西部机构审查委员会的批准，并于2021年6月获得麦吉尔大学健康中心研究伦理委员会和加拿大卫生部的批准。该试验目前正在进行中。第一名参与者于2021年7月入组，当93名参与者在2023年12月被随机分组时入组结束，试验将于2024年6月结束。在最后一名参与者退出研究后，研究团队将解除盲态进行分析。我们预计在2024年第四季度公布结果。