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Effect of central combined with peripheral intermittent theta burst stimulation on motor function in patients with hereditary spastic paraplegia: study protocol for a randomised controlled trial

Por: He · J.-P. · Yan · X.-Y. · Wang · Z.-Y. · Liu · X.-H. · Jiang · J.-Y. · Xiao · B. · Zhu · J.-P. · Zhang · N.-N. · Han · Q. · Zhan · L.-Q. · Qiu · X. · Lin · X. · Ni · J. · Lin · X.-H.
Introduction

Hereditary spastic paraplegia (HSP) is a rare neurodegenerative disorder characterised by spasticity and weakness in both lower limbs due to axonal degeneration of the corticospinal tract. Motor dysfunction is a key clinical feature of HSP, severely impacting patients’ ability to work and perform daily activities. Intermittent theta burst stimulation (iTBS), a specific form of transcranial magnetic stimulation, can induce excitatory effects by modulating stimulation duration and interval. Recently, the central-peripheral-central closed-loop rehabilitation model has gained significant attention, and its core concept is to integrate central and peripheral interventions. The objective of this study is to evaluate the effect of central combined with peripheral iTBS on motor function in adults with HSP.

Methods and analysis

In this randomised controlled trial, 40 patients admitted to the First Affiliated Hospital of Fujian Medical University will be randomly assigned (1:1 ratio) to either active iTBS or sham iTBS groups. iTBS will be administered to the bilateral primary motor cortex and common peroneal nerve, delivering a total of 4800 pulses, five times a week for 2 weeks. Throughout the iTBS treatment period, participants will also engage in conventional rehabilitation training for 30 min, five times a week for 2 weeks. The primary outcome measure will be assessed using the 10 Metre Walk Test at baseline, postintervention and 4 weeks after the intervention ends. Secondary outcomes will include the Spastic Paraplegia Rating Scale, the Modified Ashworth Scale, the Medical Research Council scale, the Berg Balance Scale, Pro-Kin balance centre of pressure parameters, the Timed Up and Go Test, RealGait gait parameters and neuro-electrophysiological indicators. Additionally, any adverse events will be recorded.

Ethics and dissemination

This study was approved by the Ethics Committee of the First Affiliated Hospital of Fujian Medical University (Approval No.: MRCTA, ECFAH of FMU (2024)862). All participants will be required to provide written informed consent. The results of the study will be submitted for publication in peer-reviewed journals.

Trial registration number

ChiCTR2500097169.

Safety and effectiveness of the Chocolate balloon catheter in the treatment of peripheral artery disease with percutaneous transluminal angioplasty: a multicentre, prospective, observational study protocol

Por: Ye · Z.-Q. · Liu · H. · Fang · X. · Meng · X.-H.
Background

Peripheral artery disease (PAD) represents a significant global health burden. Percutaneous transluminal angioplasty (PTA) is the most commonly employed endovascular intervention; however, its long-term efficacy is often compromised by restenosis and flow-limiting dissection. The Chocolate balloon catheter, characterised by a nitinol-constrained design that enables controlled, segmental vessel dilation, has demonstrated potential in minimising vascular trauma and enhancing patency. Nevertheless, there remains a lack of robust multicentre evidence evaluating its safety and effectiveness in real-world Chinese PAD populations. This protocol outlines a prospective, multicentre, single-arm observational study aiming to assess the 12 month primary patency and complication rates following Chocolate balloon PTA in Chinese patients with femoropopliteal or infrapopliteal lesions.

Methods and analysis

This prospective, multicentre, single-arm observational study will be conducted across eight medical centres in China. Eligible patients with symptomatic PAD (Rutherford classification 2–5) and de novo or restenotic lesions in the femoropopliteal or infrapopliteal arteries, for whom the use of a Chocolate balloon catheter is indicated as per standard care, will be enrolled. All participants will undergo percutaneous transluminal angioplasty using the Chocolate balloon catheter and will be followed up for 12 months. The primary outcome is the primary patency rate of the target lesion at 12 months, defined as the absence of restenosis (diameter stenosis

Ethics and dissemination

The study protocol was approved by the Clinical Trial Ethics Committee of Hangzhou First People’s Hospital (Approval No. IIT-20220606-0082-01). The findings will be disseminated in peer-reviewed publications.

Trial registration number

NCT06933992.

Effect of acupoint stimulation after caesarean section: a protocol for systematic review with meta-analysis and trial sequential analysis

Por: Xiong · F.-j. · Zhao · W. · Jia · S.-j. · Song · K. · Lei · X.-h. · Jia · W.-n. · Chen · L.-m. · Nie · H.-m.
Introduction

Although caesarean sections (CSs) are essential for the management of obstructed labour and other obstetric complications, postoperative pain, delayed recovery and complication risks continue to be significant challenges in perioperative management. Improvements in traditional medications and surgical techniques have helped, yet issues, including medication side effects and extended recovery times, persist. Therefore, it is particularly important to seek non-pharmacological interventions, such as acupoint stimulation, to optimise the perioperative management of CS. The aim of this systematic review protocol is to synthesise the available evidence and assess the effect of acupoint stimulation in the perioperative period of CS.

Methods and analysis

We plan to search PubMed, Web of Science, EMBASE, Scopus, the Cochrane Library and China National Knowledge Infrastructure, from their inception to August 2025. Primary outcome indicators will include pain, time to first defecation, time to first bowel movement and time to return of bowel sounds. Secondary outcome indicators will include postoperative complications, such as nausea and vomiting, bloating, anxiety and depression, as well as length of hospital stay and morphine consumption. Subgroup analyses, meta-regression and sensitivity analyses will be used to investigate the potential sources of heterogeneity and to test the stability of the results. Trial sequential analysis will be introduced to enhance the reliability of the evidence.

Ethics and dissemination

No ethical approval is required as this study synthesises the existing published data. Results will be disseminated through peer-reviewed publications and conference presentations. Any protocol amendments will be documented in PROSPERO and detailed in the final publication.

PROSPERO registration number

CRD42024558572.

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