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远程传递环境丰富干预创伤性脑损伤:一项随机对照试验的研究方案。

Remotely delivered environmental enrichment intervention for traumatic brain injury: Study protocol for a randomised controlled trial.

机构信息

Department of Psychology, University of Toronto, Toronto, Ontario, Canada

Rotman Research Institute at Baycrest, Toronto, Ontario, Canada.

出版信息

BMJ Open. 2021 Feb 11;11(2):e039767. doi: 10.1136/bmjopen-2020-039767.

DOI:10.1136/bmjopen-2020-039767
PMID:33574141
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7880099/
Abstract

INTRODUCTION

Individuals with moderate-severe traumatic brain injury (m-sTBI) experience progressive brain and behavioural declines in the chronic stages of injury. Longitudinal studies found that a majority of patients with m-sTBI exhibit significant hippocampal atrophy from 5 to 12 months post-injury, associated with decreased cognitive environmental enrichment (EE). Encouragingly, engaging in EE has been shown to lead to neural improvements, suggesting it is a promising avenue for offsetting hippocampal neurodegeneration in m-sTBI. Allocentric spatial navigation (ie, flexible, bird's eye view approach), is a good candidate for EE in m-sTBI because it is associated with hippocampal activation and reduced ageing-related volume loss. Efficacy of EE requires intensive daily training, prohibitive within most current health delivery systems. The present protocol is a novel, remotely delivered and self-administered intervention designed to harness principles from EE and allocentric spatial navigation to offset hippocampal atrophy and potentially improve hippocampal functions such as navigation and memory for patients with m-sTBI.

METHODS AND ANALYSIS

Eighty-four participants with chronic m-sTBI are being recruited from an urban rehabilitation hospital and randomised into a 16-week intervention (5 hours/week; total: 80 hours) of either targeted spatial navigation or an active control group. The spatial navigation group engages in structured exploration of different cities using Google Street View that includes daily navigation challenges. The active control group watches and answers subjective questions about educational videos. Following a brief orientation, participants remotely self-administer the intervention on their home computer. In addition to feasibility and compliance measures, clinical and experimental cognitive measures as well as MRI scan data are collected pre-intervention and post-intervention to determine behavioural and neural efficacy.

ETHICS AND DISSEMINATION

Ethics approval has been obtained from ethics boards at the University Health Network and University of Toronto. Findings will be presented at academic conferences and submitted to peer-reviewed journals.

TRIAL REGISTRATION NUMBER

Version 3, ClinicalTrials.gov Registry (NCT04331392).

摘要

简介

患有中重度创伤性脑损伤(m-sTBI)的个体在损伤后的慢性阶段会出现进行性的大脑和行为衰退。纵向研究发现,大多数 m-sTBI 患者在受伤后 5 至 12 个月会出现明显的海马体萎缩,与认知环境丰富度(EE)降低有关。令人鼓舞的是,参与 EE 已被证明可以促进神经改善,这表明它是抵消 m-sTBI 中海马体神经退行性变的有前途的途径。非定域空间导航(即灵活的、鸟瞰式方法)是 m-sTBI 中 EE 的一个很好的候选方法,因为它与海马体激活和减少与年龄相关的体积损失有关。EE 的疗效需要密集的日常训练,但在大多数当前的医疗保健系统中都是不可行的。本方案是一种新颖的、远程提供和自我管理的干预措施,旨在利用 EE 和非定域空间导航的原则来抵消海马体萎缩,并可能改善 m-sTBI 患者的海马体功能,如导航和记忆。

方法和分析

正在从一家城市康复医院招募 84 名患有慢性 m-sTBI 的参与者,并将他们随机分为 16 周的干预组(每周 5 小时;共 80 小时),干预组接受有针对性的空间导航或积极对照组。空间导航组使用 Google 街景探索不同城市,并包括日常导航挑战。积极对照组观看并回答关于教育视频的主观问题。在短暂的介绍后,参与者在家用电脑上远程自我管理干预。除了可行性和依从性测量外,还在干预前和干预后收集临床和实验认知测量以及 MRI 扫描数据,以确定行为和神经疗效。

伦理和传播

该研究已获得多伦多大学健康网络和多伦多大学伦理委员会的批准。研究结果将在学术会议上进行汇报,并提交给同行评议的期刊。

试验注册号

第 3 版,ClinicalTrials.gov 注册表(NCT04331392)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1493/7880099/1e1e57f98ee9/bmjopen-2020-039767f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1493/7880099/1e1e57f98ee9/bmjopen-2020-039767f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1493/7880099/1e1e57f98ee9/bmjopen-2020-039767f01.jpg

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