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.

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Maria I Lapid, Sandeep R Pagali, Michael R Basso, Paul E Croarkin, Jennifer R Geske, John Huston, Karimul Islam, Boney Joseph, Walter W Kennebeck, Daehun Kang, Simon Kung, Allison M LeMahieu, Brian N Lundstrom, Ronald C Petersen, Mikaela M Sarran, Yunhong Shu, Ilya M Swanson, Erik K St Louis, Melissa K Wang, Yogatheesan Varatharajah, Neeraj Wagh, Kirk M Welker, Gregory A Worrell, Bradley F Boeve
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引用次数: 0

Abstract

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.

Abstract Image

Abstract Image

Abstract Image

间歇性θ波爆发刺激(iTBS)和重复经颅磁刺激(rTMS)改善轻度认知障碍(MCI)患者记忆的先导随机对照双盲试验:研究方案。
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(ADRD),这强调了有效干预的必要性。早期干预MCI是至关重要的,不仅可以缓解症状,而且可以潜在地延缓认知能力下降的进展。MCI缺乏明确的治疗方法,这促使人们探索替代的非药物治疗方法。具体来说,使用重复经颅磁刺激(rTMS)的无创脑刺激在改善MCI和AD患者的认知方面表现出了希望。目的:本研究将验证间歇性θ波爆发刺激(iTBS)技术在轻度认知损伤中应用的可行性,对研究设计进行试点测试,并收集iTBS在三个不同脑区对轻度认知损伤中工作记忆、新学习和执行功能影响的试点数据。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潜在生物标志物的可行性和实用性。方法:对20名轻度认知障碍参与者进行随机双盲对照iTBS交叉试验,随机分为10天的活动iTBS(左背外侧前额叶皮层或左外侧顶叶皮层)或对照组(顶点)。在4-6周的洗脱期后,他们转入另一个10天的替代治疗组。每位参与者将接受总共20个iTBS课程。itbs前后的评估包括神经心理测试、功能磁共振成像(fMRI)、HD-EEG和睡眠结构。讨论:这项创新研究旨在测试iTBS作为MCI认知增强策略的可行性。如果我们的研究是可行的,它可能会导致未来更大规模的试验,以进一步测试iTBS是否可以调节潜在的神经生物学,并提供治疗途径来修复轻度认知损伤的认知能力下降或最终延缓痴呆的进展。试验注册:ClinicalTrials.gov, NCT05327257。注册于2022年4月4日。
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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
期刊介绍: Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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