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神经系统疾病和损伤患者的远程神经心理学评估——一项横断面病例对照验证研究的研究方案

Remote neuropsychological assessment of patients with neurological disorders and injuries-a study protocol for a cross-sectional case-control validation study.

作者信息

Berginström Nils, Andersson Linus

机构信息

Department of Community Medicine and Rehabilitation, Rehabilitation Medicine, Umeå University, Umeå, Sweden

Department of Psychology, Umeå University, Umeå, Sweden.

出版信息

BMJ Open. 2024 Apr 22;14(4):e080628. doi: 10.1136/bmjopen-2023-080628.

Abstract

INTRODUCTION

There are great potential benefits of being able to conduct neuropsychological assessments remotely, especially for hard-to-reach or less mobile patient groups. Such tools need to be equivalent to standard tests done in the clinic and also easy to use in a variety of clinical populations.

METHODS AND ANALYSIS

This study protocol describes a cross-sectional study aimed at validating the newly developed digitalized neuropsychological test battery Mindmore Remote in patients with neurological disorders and injuries. Diagnoses comprise traumatic brain injury, stroke, Parkinson's disease, multiple sclerosis, brain tumour and epilepsy. 50 patients in each patient group will be included. In addition, 50 healthy controls will be recruited. All participants will undergo both testing with Mindmore Remote at home and traditional neuropsychological assessment face-to-face in a randomised order. The primary outcome is the association between tests from the Mindmore Remote battery and their equivalent traditional neuropsychological tests. Further, bias between methods and differences between groups will also be investigated.

ETHICS AND DISSEMINATION

The study protocol has been approved by the Swedish Ethical Review Authority (2022-06230-01) and adheres to the declaration of Helsinki. All participants will be given oral and written information about the study and sign informed consent forms before entering the study. All participants are informed that they can terminate their participation in the study at any given time, without giving any explanation, and participating in the study or not will not affect their care at the clinic. Neither authors nor personnel involved in the research project are affiliated with Mindmore AB. The results from the study will be published in peer-reviewed scientific journals and presented at national and international conferences on the topic.

TRIAL REGISTRATION NUMBER

NCT05819008.

摘要

引言

能够远程进行神经心理学评估有诸多潜在益处,特别是对于难以接触到或行动不便的患者群体。此类工具需要等同于在诊所进行的标准测试,并且易于在各种临床人群中使用。

方法与分析

本研究方案描述了一项横断面研究,旨在验证新开发的数字化神经心理测试组合Mindmore Remote在患有神经系统疾病和损伤的患者中的有效性。诊断包括创伤性脑损伤、中风、帕金森病、多发性硬化症、脑肿瘤和癫痫。每个患者组将纳入50名患者。此外,将招募50名健康对照者。所有参与者将以随机顺序在家中接受Mindmore Remote测试以及在面对面进行传统神经心理学评估。主要结局是Mindmore Remote测试组合中的测试与其等效的传统神经心理学测试之间的关联。此外,还将研究方法之间的偏差以及组间差异。

伦理与传播

该研究方案已获得瑞典伦理审查局批准(2022 - 06230 - 01),并遵循赫尔辛基宣言。所有参与者在进入研究前将获得关于该研究的口头和书面信息,并签署知情同意书。所有参与者被告知他们可以在任何时候终止参与研究,无需给出任何解释,参与研究与否均不会影响他们在诊所的治疗。研究项目的作者和人员均与Mindmore AB无关联。研究结果将发表在同行评审的科学期刊上,并在关于该主题的国内和国际会议上展示。

试验注册号

NCT05819008。

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