LoBue Christian, Chiang Hsueh-Sheng, Salter Amber, McClintock Shawn, Nguyen Trung P, Logan Rebecca, Smernoff Eric, Pandya Seema, Hart John
Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA; Department of Neurological Surgery, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Department of Neurology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
J Prev Alzheimers Dis. 2025 Feb;12(2):100023. doi: 10.1016/j.tjpad.2024.100023. Epub 2025 Jan 1.
Recent disease-modifying treatments for Alzheimer's disease show promise to slow cognitive decline, but show no efficacy towards reducing symptoms already manifested.
To investigate the efficacy of a novel noninvasive brain stimulation technique in modulating cognitive functioning in Alzheimer's dementia (AD).
Pilot, randomized, double-blind, parallel, sham-controlled study SETTING: Clinical research site at UT Southwestern Medical Center PARTICIPANTS: Twenty-five participants with clinical diagnoses of AD were enrolled from cognition specialty clinics.
Treatment consisted of high definition transcranial direct current stimulation (HD-tDCS) delivered for 20 min over the medial prefrontal cortex. Ten sessions of sham, 1 mA, or 2 mA stimulation were received.
Cognitive outcomes were measured at baseline, after the last HD-tDCS session, and 8-weeks post-treatment. The primary outcome was change in total learning and delayed recall on the Rey Auditory Verbal Learning Test (RAVLT) immediately post-treatment and at 8-weeks. Secondary outcomes included measures of language, processing speed, and executive functioning. A multi-stage approach was used to examine cognitive outcomes, which included evaluation of effect sizes, statistical effects, and rate of clinically meaningful responses.
In this pilot trial, no statistically significant differences on cognitive outcomes were found between sham and active HD-tDCS immediately post-treatment (p's > 0.05). However, moderate-to-large effect sizes were identified for enhanced RAVLT total learning (Cohen's d = 0.69-0.93) and phonemic fluency (d = 1.08-1.49) for both active HD-tDCS conditions compared to sham, with rates of clinically relevant improvement between 25 and 33%. Meaningful enhancement persisted to 8 weeks only for the 1 mA condition.
Multiple sessions of HD-tDCS over the medial prefrontal cortex appears to have potential to produce meaningful cognitive enhancements in a proportion of patients having AD with improvements maintained for at least 8 weeks in some.
ClinicalTrials.gov (NCT05270408). Registered December 30, 2021.
近期用于治疗阿尔茨海默病的疾病修饰疗法有望减缓认知衰退，但对减轻已出现的症状无效。
研究一种新型非侵入性脑刺激技术对调节阿尔茨海默病痴呆（AD）患者认知功能的疗效。
试点、随机、双盲、平行、假对照研究
德克萨斯大学西南医学中心临床研究站点
从认知专科诊所招募了25名临床诊断为AD的参与者。
治疗包括在内侧前额叶皮质进行20分钟的高清经颅直流电刺激（HD-tDCS）。接受了10次假刺激、1毫安或2毫安的刺激。
在基线、最后一次HD-tDCS治疗后以及治疗后8周测量认知结果。主要结果是治疗后立即和8周时雷伊听觉词语学习测验（RAVLT）的总学习和延迟回忆的变化。次要结果包括语言、处理速度和执行功能的测量。采用多阶段方法检查认知结果，包括效应大小评估、统计效应评估和临床有意义反应率评估。
在这项试点试验中，治疗后立即进行假刺激和活性HD-tDCS之间在认知结果上未发现统计学显著差异（p值>0.05）。然而，与假刺激相比，两种活性HD-tDCS条件下RAVLT总学习（科恩d值=0.69-0.93）和音素流畅性（d值=1.08-1.49）均有中等到较大的效应大小，临床相关改善率在25%至33%之间。只有1毫安条件下的有意义增强持续到8周。
在内侧前额叶皮质进行多次HD-tDCS似乎有可能在一部分AD患者中产生有意义的认知增强，部分患者的改善可维持至少8周。
ClinicalTrials.gov（NCT05270408）。2021年12月30日注册。
