Home-Based Tele-tDCS in Amyotrophic Lateral Sclerosis: Feasibility, Safety, and Preliminary Efficacy

IF 3.9 2区医学 Q1 CLINICAL NEUROLOGY Annals of Clinical and Translational Neurology Pub Date : 2025-03-24 DOI:10.1002/acn3.70038

Sangeetha Madhavan, Shravni Deshmukh, Mark Cummings, Aditi Doshi, Kourosh Rezania, Sally Freels, Gina Sawa

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Abstract

Objective

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease with limited treatment options. Transcranial direct current stimulation (tDCS) shows promise as a neuromodulatory intervention in various neurological disorders, but its application in ALS, particularly in a remote, home-based format, remains underexplored. This study investigates the feasibility, safety, and preliminary efficacy of remotely supervised tele-tDCS in ALS patients.

Methods

This double-blinded pilot study included 14 spinal-onset ALS participants randomized into two groups: the intervention group received 72 tele-tDCS sessions over 24 weeks, and the delayed-start group received 36 sham sessions followed by 36 tele-tDCS sessions. Stimulation was delivered at 2 mA for 20 min 3 times a week. Primary outcomes included feasibility, safety, and disease progression measured by the ALS Functional Rating Scale-Revised (ALSFRS-R). Adherence and adverse effects were monitored throughout.

Results

Ten participants completed the study, with an overall compliance rate of 98.3%. No serious adverse events were reported, and mild side effects, like itching and tingling, were consistent with tDCS literature. The intervention group demonstrated a significantly slower decline in ALSFRS-R scores than the delayed-start group. At 24 weeks, the intervention group had a mean ALSFRS-R change of −1.7, compared to −13.6 in the delayed-start group (p = 0.0018). Additionally, the change in ALSFRS-R between pre- and mid-intervention significantly differed between groups (p = 0.0071).

Interpretation

Tele-tDCS was feasible, safe, and well-tolerated in individuals with ALS. Preliminary efficacy results suggest that tele-tDCS may slow disease progression, underscoring the potential of tele-tDCS as a promising home-based neuromodulatory intervention in ALS management.

Trial Registration: Clinical trial registration: NCT04866771

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家庭远程tdcs治疗肌萎缩性侧索硬化症：可行性、安全性和初步疗效。

目的：肌萎缩性侧索硬化症（ALS）是一种进行性神经退行性疾病，治疗方案有限。经颅直流电刺激（tDCS）作为一种神经调节干预在各种神经系统疾病中显示出前景，但其在ALS中的应用，特别是在远程，基于家庭的形式，仍未得到充分探索。本研究探讨了远程监控远程tdcs在ALS患者中的可行性、安全性和初步疗效。方法：这项双盲先导研究包括14名脊髓性ALS患者，随机分为两组：干预组在24周内接受72次远程tdcs治疗，延迟启动组接受36次假治疗，随后接受36次远程tdcs治疗。每周3次，每次2毫安，持续20分钟。主要结局包括可行性、安全性和ALS功能评定量表-修订版（ALSFRS-R）测量的疾病进展。全程监测依从性和不良反应。结果：10名参与者完成了研究，总体依从率为98.3%。没有严重不良事件的报道，轻微的副作用，如瘙痒和刺痛，与tDCS文献一致。干预组ALSFRS-R评分下降明显慢于延迟启动组。在24周时，干预组的平均ALSFRS-R变化为-1.7，而延迟启动组为-13.6 （p = 0.0018）。此外，ALSFRS-R在干预前和干预中期的变化在组间有显著差异（p = 0.0071）。结论：远程tdcs在ALS患者中是可行、安全且耐受性良好的。初步疗效结果表明，远程tdcs可能减缓疾病进展，强调远程tdcs作为一种有前途的家庭神经调节干预治疗ALS的潜力。临床试验注册：NCT04866771。

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来源期刊

Annals of Clinical and Translational Neurology Medicine-Neurology (clinical)

CiteScore

9.10

自引率

1.90%

发文量

218

审稿时长

8 weeks

期刊介绍： Annals of Clinical and Translational Neurology is a peer-reviewed journal for rapid dissemination of high-quality research related to all areas of neurology. The journal publishes original research and scholarly reviews focused on the mechanisms and treatments of diseases of the nervous system; high-impact topics in neurologic education; and other topics of interest to the clinical neuroscience community.