Intermittent theta burst stimulation vs. high-frequency repetitive transcranial magnetic stimulation for post-stroke cognitive impairment: Protocol of a pilot randomized controlled double-blind trial

Abstract

IntroductionIntermittent theta burst stimulation (iTBS), a novel mode of transcranial magnetic stimulation (TMS), has curative effects on patients with post-stroke cognitive impairment (PSCI). However, whether iTBS will be more applicable in clinical use than conventional high-frequency repetitive transcranial magnetic stimulation (rTMS) is unknown. Our study aims to compare the difference in effect between iTBS and rTMS in treating PSCI based on a randomized controlled trial, as well as to determine its safety and tolerability, and to further explore the underlying neural mechanism.MethodsThe study protocol is designed as a single-center, double-blind, randomized controlled trial. Forty patients with PSCI will be randomly assigned to two different TMS groups, one with iTBS and the other with 5 Hz rTMS. Neuropsychological evaluation, activities of daily living, and resting electroencephalography will be conducted before treatment, immediately post-treatment, and 1 month after iTBS/rTMS stimulation. The primary outcome is the change in the Montreal Cognitive Assessment Beijing Version (MoCA-BJ) score from baseline to the end of the intervention (D11). The secondary outcomes comprise changes in resting electroencephalogram (EEG) indexes from baseline to the end of the intervention (D11) as well as the Auditory Verbal Learning Test, the symbol digit modality test, the Digital Span Test findings, and the MoCA-BJ scores from baseline to endpoint (W6).DiscussionIn this study, the effects of iTBS and rTMS will be evaluated using cognitive function scales in patients with PSCI as well as data from resting EEG, which allows for an in-depth exploration of underlying neural oscillations. In the future, these results may contribute to the application of iTBS for cognitive rehabilitation of patients with PSCI.

Rapid improvements and subsequent effects in major depressive disorder patients with somatic pain using rTMS combined with sertraline

“…Previous evidence has shown that routine high-frequency rTMS promotes neurogenesis in the human motor cortex more effectively than in rat models 32 . iTBS has also been shown to have a significant role in reducing cognitive dysfunction after stroke 33 . These findings further confirm the role of iTBS in improving cognitive function and the role of rTMS in enhancing cognitive function in MDD, and may explain why the treatment effect and ERP changes were more significant in the CT group than the DT group in the present study.…”

Catgut embedding in acupoints combined with repetitive transcranial magnetic stimulation for the treatment of postmenopausal osteoporosis: study protocol for a randomized clinical trial

“…Test power 1-β = 0.95. Using G*Power3.1.9.7 software and single factor analysis of variance in the F test ( 27 , 28 ), the required sample size of n = 87 cases was calculated, and the shedding rate was set at 10%. The total sample size was 96 cases, and the required sample size for each group was 32 cases.…”

Applications of Functional Near-Infrared Spectroscopy (fNIRS) Neuroimaging During Rehabilitation Following Stroke: A Review

“…No consensus currently exists regarding the superiority of either conventional rTMS or iTBS for treating patients with PSCI. Therefore, we aimed to examine the variations between iTBS and rTMS in PSCI patients [ 70 ], using fNIRS to study the neural activity changes induced by each intervention. In doing so, we aimed to establish a theoretical foundation for clinical application.…”