Transcranial direct current stimulation (tDCS) for neurological disability among subacute stroke survivors to improve multiple domains in health-related quality of life: Randomized controlled trial protocol

IF 2.7 4区医学 Q2 CLINICAL NEUROLOGY Neurophysiologie Clinique/Clinical Neurophysiology Pub Date : 2024-04-24 DOI:10.1016/j.neucli.2024.102976

Vandana Esht , Mohammed M Alshehri , Karthick Balasubramanian , Ramya R Sanjeevi , Mohammed A Shaphe , Ahmed Alhowimel , Aqeel M Alenazi , Bader A Alqahtani , Norah Alhwoaimel

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Abstract

Objectives

The primary goal of the current proposal is to fill the gaps in the literature by studying the effectiveness of transcranial direct current stimulation (tDCS) on lifestyle parameters, and physical, behavioral, and cognitive functions among stroke survivors, and understanding the factors that mediate the effects of various domains related to Health-related Quality of life (HRQoL) improvements.

Methods

Anticipated 64 volunteer subacute stroke survivors (>7 days to 3 months post stroke) aged 40–75 years with National Institutes of Health stroke scale (NIHSS) score of >10 and Mini-Mental State Examination (MMSE) score between 18 and 23 will be randomly assigned at a ratio of 1:1 to receive either: (1) 20 sessions of anodal tDCS or (2) sham tDCS in addition to conventional rehabilitation. Battery driven tDCS will be applied at 2 mA intensity to the dorsolateral prefrontal cortex and primary motor cortex for 20 minutes. The primary endpoints of study will be 36-Item Short Form Survey (SF-36) post intervention at 4 weeks. The secondary outcomes will include Stroke Specific Quality of Life Scale (SS_QOL), Montreal cognitive assessment (MCA), Beck Anxiety Inventory (BAI), Fugl-Meyer Assessment (FMA), 10 m walk test and Modified Barthel Activities of daily living (ADL) Index. At 0.05 level of significance, data normality, within group and between group actual differences will be analyzed with a moderate scope software.

Discussion

Our knowledge of this technique and its use is expanding daily as tDCS motor recovery studies—mostly single-center studies—in either single session or many sessions have been completed and shown positive results. The field is prepared for a multi-center, carefully planned, sham-controlled, double-blinded tDCS study to comprehensively examine its feasibility and effectiveness in enhancing outcomes in stroke population.

Conclusion

The function of Transcranial Direct Current Stimulation in aiding stroke recuperation will be ascertained.

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经颅直流电刺激（tDCS）治疗亚急性中风幸存者的神经残疾，以改善多个领域的健康相关生活质量：随机对照试验方案

目的本提案的主要目的是通过研究经颅直流电刺激（tDCS）对中风幸存者的生活方式参数以及身体、行为和认知功能的影响，了解与健康相关生活质量（HRQoL）改善有关的各个领域的中介效应因素，从而填补文献空白。方法将按 1:1 的比例随机分配 64 名年龄在 40-75 岁之间、美国国立卫生研究院中风量表（NIHSS）评分为 10 分、迷你精神状态检查（MMSE）评分在 18 分到 23 分之间的亚急性中风幸存者（中风后 7 天到 3 个月）接受：（1）20 次阳极 tDCS 或（2）常规康复治疗之外的假 tDCS。电池驱动的 tDCS 将以 2 mA 的强度作用于背外侧前额叶皮层和初级运动皮层，持续 20 分钟。研究的主要终点是干预后 4 周的 36 项简表调查（SF-36）。次要结果包括脑卒中生活质量量表（SS_QOL）、蒙特利尔认知评估（MCA）、贝克焦虑量表（BAI）、福格尔-迈耶评估（FMA）、10 米步行测试和改良巴特尔日常生活活动指数（ADL）。在 0.05 的显著性水平下，将使用中等范围的软件分析数据的正态性、组内和组间的实际差异。讨论随着 tDCS 运动恢复研究（大多数是单中心研究）的完成，我们对这项技术及其应用的了解与日俱增。该领域正准备开展一项多中心、精心策划、假对照、双盲的 tDCS 研究，以全面检查其在改善中风患者预后方面的可行性和有效性。

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来源期刊

Neurophysiologie Clinique/Clinical Neurophysiology 医学-临床神经学

CiteScore

5.20

自引率

3.30%

发文量

审稿时长

60 days

期刊介绍： Neurophysiologie Clinique / Clinical Neurophysiology (NCCN) is the official organ of the French Society of Clinical Neurophysiology (SNCLF). This journal is published 6 times a year, and is aimed at an international readership, with articles written in English. These can take the form of original research papers, comprehensive review articles, viewpoints, short communications, technical notes, editorials or letters to the Editor. The theme is the neurophysiological investigation of central or peripheral nervous system or muscle in healthy humans or patients. The journal focuses on key areas of clinical neurophysiology: electro- or magneto-encephalography, evoked potentials of all modalities, electroneuromyography, sleep, pain, posture, balance, motor control, autonomic nervous system, cognition, invasive and non-invasive neuromodulation, signal processing, bio-engineering, functional imaging.