Efficacy and safety of high-dose and personalized TBS on post-stroke cognitive impairment: A randomized controlled trial

IF 7.6 1区医学 Q1 CLINICAL NEUROLOGY Brain Stimulation Pub Date : 2025-02-18 DOI:10.1016/j.brs.2025.02.009

Jianxun Ren , Wenlong Su , Ying Zhou , Kaiyue Han , Ruiqi Pan , Xinyu Duan , Jiajie Liu , Haitao Lu , Ping Zhang , Wei Zhang , Jian Sun , Mengying Ding , Yafei Zhu , Wuxiang Xie , Jianting Huang , Hao Zhang , Hesheng Liu

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Abstract

Background

Cognitive impairments are prevalent among stroke patients, impacting independent living. While intermittent theta burst stimulation (iTBS) shows potential for rehabilitation, the efficacy of the commonly-used doses remains unsatisfactory.

Objective

To investigate the efficacy, dose-dependent effect, and safety of high-dose iTBS targeting the individualized frontoparietal cognitive network (FCN) for post-stroke cognitive recovery.

Methods

In a randomized, sham-controlled, three-arm trial, patients with post-stroke cognitive impairment (PSCI) received 15 days of high-dose (3600 pulses/day), standard low-dose (1200 pulses/day) as an active control, or sham iTBS targeting the individualized FCN, alongside cognitive training. Primary outcome measured changes in global cognition via the Montreal Cognitive Assessment (MoCA). Secondary measures included MoCA response rates and score changes in the Wechsler Memory Scale, Wechsler Adult Intelligence Scale, and Mini-Mental State Examination.

Results

Of forty-five randomized participants, forty-one (8 women; mean [SD] age, 58.63 [8.64] years) were analyzed. Personalized targeting improved focality by 33.0 % over the standard F3 target in E-field analysis. Both high-dose and standard low-dose groups showed significant improvements in MoCA. Importantly, the high-dose group demonstrated superior cognitive recovery over both the active control group (estimated difference = 2.50, p = 0.0339, 95 % CI = 0.15–4.84) and the sham control group (estimated difference = 4.29, p = 0.0001, 95 % CI = 1.99–6.60), indicating a superior effect of high-dose stimulation for cognitive recovery. Similar high-dose and dose-dependent effects were observed in other secondary outcomes, suggesting consistent effects on the memory, intelligence, and mental state. No serious adverse events occurred.

Conclusions

This study highlights the efficacy and safety of high-dose iTBS targeting the individualized FCN for post-stroke cognitive recovery.

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来源期刊

Brain Stimulation 医学-临床神经学

CiteScore

13.10

自引率

9.10%

发文量

256

审稿时长

72 days

期刊介绍： Brain Stimulation publishes on the entire field of brain stimulation, including noninvasive and invasive techniques and technologies that alter brain function through the use of electrical, magnetic, radiowave, or focally targeted pharmacologic stimulation. Brain Stimulation aims to be the premier journal for publication of original research in the field of neuromodulation. The journal includes: a) Original articles; b) Short Communications; c) Invited and original reviews; d) Technology and methodological perspectives (reviews of new devices, description of new methods, etc.); and e) Letters to the Editor. Special issues of the journal will be considered based on scientific merit.