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Investigating the efficacy of electroacupuncture for postoperative ileus in patients with colorectal cancer: study protocol for a multicentre clinical trial with neuroimaging assessment

Por: Wang · Z.-Y. · Liu · C.-Z. · Pei · W. · Zhang · T.-Z. · Zhang · J. · Fan · W.-W. · Wei · X.-Y. · Tu · J.-F. · Wang · L. · Wang · X. · Yang · N.-N.
Introduction

Postoperative ileus (POI) is a prevalent complication following abdominal surgeries, significantly compromising patients’ quality of life and imposing a socioeconomic burden. Electroacupuncture (EA), a widely used therapeutic approach in China, has shown promise as an effective intervention for POI. However, the neural mechanism underlying its therapeutic effects remains unclear. Thus, this study aims to evaluate the efficacy of EA treatment for POI and investigate its central mechanism by functional MRI (fMRI).

Methods and analysis

This randomised controlled clinical trial will be conducted across three hospitals in China. A total of 50 eligible patients with colorectal cancer scheduled for elective laparoscopic surgery will be randomly assigned to either the EA or sham electroacupuncture (SA) group in a 1:1 ratio. All patients will undergo 5 sessions of 30 min EA or SA over 5 consecutive days post-surgery (once daily). Resting-state fMRI (rs-fMRI) scans will be performed at baseline and the end of treatment to examine brain functional changes related to EA treatment. The primary outcome is the time to first defecation. Secondary outcomes include the time to first flatus, ambulation, tolerability of semiliquid and solid food; length of postoperative hospital stay; severity of postoperative pain, abdominal distension and nausea; frequency of postoperative nausea and vomiting episodes; rate of readmission. Postoperative complications will be monitored and documented throughout the trial duration. Credibility and expectancy evaluation, along with blinding assessment, will be conducted after the first treatment session. Pearson/Spearman correlation analysis will be performed to determine the relationship between clinical variables and rs-fMRI metrics.

Ethics and dissemination

This protocol has been approved by the ethics committees of Beijing University of Chinese Medicine (number 2024BZYLL0113), Cancer Hospital Chinese Academy of Medical Sciences (number 24/323-4603), Beijing Friendship Hospital Affiliated to Capital Medical University (number 2024-P2-081-01) and Beijing Chaoyang Huanxing Cancer Hospital (number 2024-011-02). Participants will sign the paper-based informed consent form before enrolment. The results will be disseminated through peer-reviewed publications.

Trial registration number

ITMCTR2024000504.

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.

Anti-inflammatory therapy for recurrent in-stent restenosis (AI-ISR): study protocol for a prospective, randomised, open-label, multicentre clinical trial

Por: Yu · M. · Jiang · Y. · Song · Z. · Wei · Z.-Y. · Tan · F. · Liu · X. · Zhang · X. · Zhu · F. · Shi · Y. · Huang · J. · Yang · W.-X. · Qian · H.-Y.
Introduction

Recurrent in-stent restenosis (RISR) remains a major therapeutic challenge in patients undergoing percutaneous coronary intervention (PCI), with a high incidence of repeat revascularisation and increased mortality. Immune-mediated inflammation has been implicated in the pathogenesis of RISR. This trial aims to evaluate the clinical efficacy and safety of two anti-inflammatory strategies—low-dose colchicine and prednisone—on reducing ISR recurrence and cardiovascular events.

Methods and analysis

This is a multicentre, prospective, randomised, open-label controlled trial enrolling 252 patients with RISR. Following successful PCI, patients are randomly assigned (1:1:1) to receive: (1) standard medical therapy (control group); (2) colchicine 0.5 mg/day (colchicine group) or (3) prednisone 0.5 mg/kg/day, tapered monthly to 5–10 mg/day over 12 months (prednisone group). All groups receive background standard therapy per guidelines. The primary endpoint is angiographically confirmed ISR of the target lesion at 12 months post PCI. Secondary endpoints include the incidence of major adverse cardiovascular and cerebrovascular events (cardiovascular death, myocardial infarction, stroke and target vessel revascularisation), target lesion revascularisation and revascularisation of non-target coronary lesions within 12 months.

Ethics and dissemination

This trial has received ethical approval from the Ethics Committee of Fuwai Hospital (Chinese Academy of Medical Sciences and Peking Union Medical College), which acts as the central institutional review board. All participants will provide written informed consent. Study results will be disseminated via peer-reviewed journals and conference presentations.

Trial registration number

ClinicalTrials.gov, NCT06090890. Registered 15 October 2023, https://clinicaltrials.gov/study/NCT06090890.

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