间歇性theta爆发刺激（iTBS）重复经颅磁刺激（rTMS）改善轻度认知障碍（MCI）记忆的一项前瞻性随机对照双盲试验：研究方案
A pilot randomized controlled double-blind trial of intermittent theta burst stimulation (iTBS) repetitive transcranial magnetic stimulation (rTMS) to improve memory in mild cognitive impairment (MCI): a study protocol.
作者信息
Lapid Maria I, Pagali Sandeep R, Basso Michael R, Croarkin Paul E, Geske Jennifer R, Huston John, Islam Karimul, Joseph Boney, Kennebeck Walter W, Kang Daehun, Kung Simon, LeMahieu Allison M, Lundstrom Brian N, Petersen Ronald C, Sarran Mikaela M, Shu Yunhong, Swanson Ilya M, Louis Erik K St, Wang Melissa K, Varatharajah Yogatheesan, Wagh Neeraj, Welker Kirk M, Worrell Gregory A, Boeve Bradley F
机构信息
Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN, USA.
Division of Community Internal Medicine, Geriatrics, and Palliative Care, Mayo Clinic, Rochester, MN, USA.
出版信息
Pilot Feasibility Stud. 2025 Apr 1;11(1):35. doi: 10.1186/s40814-025-01625-5.
BACKGROUND
Mild cognitive impairment (MCI), prevalent among older adults, often precedes Alzheimer's disease (AD) or Alzheimer's disease-related dementias (ADRD), emphasizing the need for effective interventions. Early intervention in MCI is crucial, not only to alleviate symptoms but to potentially delay the progression of cognitive decline. The lack of definitive treatments for MCI has prompted the exploration into alternative non-pharmacological therapeutic approaches. Specifically, noninvasive brain stimulation using repetitive transcranial magnetic stimulation (rTMS) has demonstrated promise in improving cognition in MCI and AD.
OBJECTIVES
Our study will test the feasibility of using intermittent theta burst stimulation (iTBS) technique of rTMS in MCI, pilot test the study design, and collect pilot data on the effect of iTBS over three different brain regions on working memory, new learning, and executive function in MCI. Exploratory objectives are to assess the feasibility and usefulness of functional magnetic resonance imaging (fMRI), high-density electroencephalography (HD-EEG), and sleep architecture as potential biomarkers in response to iTBS.
METHODS
A pilot randomized double-blind controlled cross-over trial of iTBS on 20 MCI participants randomized to 10 days of active iTBS (left dorsolateral prefrontal cortex or left lateral parietal cortex) or control (vertex). After 4-6-week washout period, they cross over to the alternative treatment arm for another 10 days. Each participant will undergo a total of 20 iTBS sessions. Pre- and post-iTBS assessments include neuropsychological tests, fMRI, HD-EEG, and sleep architecture.
DISCUSSION
This innovative study aims to test the feasibility of iTBS as a cognitive enhancement strategy in MCI. If our study is feasible, it could lead to a future larger trial to further test whether iTBS can modulate underlying neurobiology and offer a therapeutic avenue to remediate cognitive decline in MCI or ultimately delay progression to dementia.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT05327257. Registered 04 April 2022.
背景
轻度认知障碍（MCI）在老年人中普遍存在，通常先于阿尔茨海默病（AD）或阿尔茨海默病相关痴呆症（ADRD）出现，这凸显了有效干预措施的必要性。对MCI进行早期干预至关重要，不仅可以缓解症状，还可能延缓认知衰退的进展。由于缺乏针对MCI的确定性治疗方法，促使人们探索替代性的非药物治疗方法。具体而言，使用重复经颅磁刺激（rTMS）的无创脑刺激已显示出改善MCI和AD患者认知功能的潜力。
目的
我们的研究将测试rTMS的间歇性theta波爆发刺激（iTBS）技术在MCI中的可行性，对研究设计进行预试验，并收集关于iTBS作用于MCI患者三个不同脑区对工作记忆、新学习能力和执行功能影响的预试验数据。探索性目标是评估功能磁共振成像（fMRI）、高密度脑电图（HD-EEG）和睡眠结构作为iTBS反应潜在生物标志物的可行性和实用性。
方法
一项对20名MCI参与者进行的iTBS预试验随机双盲对照交叉试验，参与者被随机分为接受10天的主动iTBS（左侧背外侧前额叶皮质或左侧顶叶皮质）或对照（头顶）治疗。在4-6周的洗脱期后，他们交叉到另一治疗组再接受10天治疗。每位参与者总共将接受20次iTBS治疗。iTBS治疗前后的评估包括神经心理学测试、fMRI、HD-EEG和睡眠结构。
讨论
这项创新性研究旨在测试iTBS作为MCI认知增强策略的可行性。如果我们的研究可行，可能会促成未来更大规模的试验，以进一步测试iTBS是否能调节潜在神经生物学机制，并为改善MCI患者认知衰退或最终延缓向痴呆症进展提供治疗途径。
试验注册
ClinicalTrials.gov，NCT05327257。2022年4月4日注册。
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