PDF(Pubmed)
Abstract：
UNASSIGNED: Currently, the impact of drug therapies on neurodegenerative conditions is limited. Therefore, there is a strong clinical interest in non-pharmacological interventions aimed at preserving functionality, delaying disease progression, reducing disability, and improving quality of life for both patients and their caregivers. This longitudinal multicenter Randomized Controlled Trial (RCT) applies three innovative cognitive telerehabilitation (TR) methods to evaluate their impact on brain functional connectivity reconfigurations and on the overall level of cognitive and everyday functions.
UNASSIGNED: We will include 110 participants with mild cognitive impairment (MCI). Fifty-five participants will be randomly assigned to the intervention group who will receive cognitive TR via three approaches, namely: (a) Network-based Cognitive Training (NBCT), (b) Home-based Cognitive Rehabilitation (HomeCoRe), or (c) Semantic Memory Rehabilitation Training (SMRT). The control group (n = 55) will receive an unstructured home-based cognitive stimulation. The rehabilitative program will last either 4 (NBTC) or 6 weeks (HomeCoRe and SMRT), and the control condition will be adapted to each TR intervention. The effects of TR will be tested in terms of Δ connectivity change, obtained from high-density electroencephalogram (HD-EEG) or functional magnetic resonance imaging at rest (rs-fMRI), acquired before (T0) and after (T1) the intervention. All participants will undergo a comprehensive neuropsychological assessment at four time-points: baseline (T0), within 2 weeks (T1), and after 6 (T2) and 12 months (T3) from the end of TR.
UNASSIGNED: The results of this RCT will identify a potential association between improvement in performance induced by individual cognitive TR approaches and modulation of resting-state brain connectivity. The knowledge gained with this study might foster the development of novel TR approaches underpinned by established neural mechanisms to be validated and implemented in clinical practice.Clinical trial registration: [https://classic.clinicaltrials.gov/ct2/show/NCT06278818], identifier [NCT06278818].
UNASSIGNED: We will include 110 participants with mild cognitive impairment (MCI). Fifty-five participants will be randomly assigned to the intervention group who will receive cognitive TR via three approaches, namely: (a) Network-based Cognitive Training (NBCT), (b) Home-based Cognitive Rehabilitation (HomeCoRe), or (c) Semantic Memory Rehabilitation Training (SMRT). The control group (n = 55) will receive an unstructured home-based cognitive stimulation. The rehabilitative program will last either 4 (NBTC) or 6 weeks (HomeCoRe and SMRT), and the control condition will be adapted to each TR intervention. The effects of TR will be tested in terms of Δ connectivity change, obtained from high-density electroencephalogram (HD-EEG) or functional magnetic resonance imaging at rest (rs-fMRI), acquired before (T0) and after (T1) the intervention. All participants will undergo a comprehensive neuropsychological assessment at four time-points: baseline (T0), within 2 weeks (T1), and after 6 (T2) and 12 months (T3) from the end of TR.
UNASSIGNED: The results of this RCT will identify a potential association between improvement in performance induced by individual cognitive TR approaches and modulation of resting-state brain connectivity. The knowledge gained with this study might foster the development of novel TR approaches underpinned by established neural mechanisms to be validated and implemented in clinical practice.Clinical trial registration: [https://classic.clinicaltrials.gov/ct2/show/NCT06278818], identifier [NCT06278818].
摘要：
■目前，药物治疗对神经退行性疾病的影响是有限的.因此,临床上对旨在保持功能的非药物干预有强烈的兴趣，延缓疾病进展，减少残疾,改善患者及其护理人员的生活质量。这项纵向多中心随机对照试验（RCT）应用了三种创新的认知远程康复（TR）方法，以评估其对大脑功能连接重新配置以及认知和日常功能总体水平的影响。
■我们将包括110名患有轻度认知障碍（MCI）的参与者。55名参与者将被随机分配到干预组，他们将通过三种方法接受认知TR，即：(A)基于网络的认知训练(NBCT)，(b)家庭认知康复(HomeCoRe)，或(c)语义记忆康复训练(SMRT)。对照组（n=55）将接受非结构化的基于家庭的认知刺激。康复计划将持续4周（NBTC）或6周（HomeCoRe和SMRT），和控制条件将适应每个TR干预。TR的影响将根据Δ连通性变化进行测试，从高密度脑电图（HD-EEG）或静息功能磁共振成像（rs-fMRI）获得，在干预前(T0)和干预后(T1)获得。所有参与者将在四个时间点接受全面的神经心理学评估：基线（T0），2周内（T1），以及从TR结束后6个月(T2)和12个月(T3)。
■此RCT的结果将确定由个体认知TR方法引起的性能改善与静息状态脑连通性调节之间的潜在关联。通过这项研究获得的知识可能会促进以已建立的神经机制为基础的新型TR方法的发展，以在临床实践中进行验证和实施。临床试验注册：[https://经典。clinicaltrials.gov/ct2/show/NCT06278818],标识符[NCT06278818]。
■我们将包括110名患有轻度认知障碍（MCI）的参与者。55名参与者将被随机分配到干预组，他们将通过三种方法接受认知TR，即：(A)基于网络的认知训练(NBCT)，(b)家庭认知康复(HomeCoRe)，或(c)语义记忆康复训练(SMRT)。对照组（n=55）将接受非结构化的基于家庭的认知刺激。康复计划将持续4周（NBTC）或6周（HomeCoRe和SMRT），和控制条件将适应每个TR干预。TR的影响将根据Δ连通性变化进行测试，从高密度脑电图（HD-EEG）或静息功能磁共振成像（rs-fMRI）获得，在干预前(T0)和干预后(T1)获得。所有参与者将在四个时间点接受全面的神经心理学评估：基线（T0），2周内（T1），以及从TR结束后6个月(T2)和12个月(T3)。
■此RCT的结果将确定由个体认知TR方法引起的性能改善与静息状态脑连通性调节之间的潜在关联。通过这项研究获得的知识可能会促进以已建立的神经机制为基础的新型TR方法的发展，以在临床实践中进行验证和实施。临床试验注册：[https://经典。clinicaltrials.gov/ct2/show/NCT06278818],标识符[NCT06278818]。
