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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.

Natural history, clinical outcomes and predictors of disease course in paediatric IgA vasculitis: protocol for a multicentre prospective cohort study in Guangxi Zhuang Autonomous Region, China

Por: Jiang · H.-H. · Meng · X.-Y. · Liang · Q. · Li · R.-J. · Tang · Q. · Huang · L. · Yun · X. · Shan · Q.-W. · Chen · X.-Q.
Introduction IgA vasculitis (IgAV, formerly Henoch-Schönlein purpura) is a systemic small-vessel vasculitis. The aetiology of IgAV is multifactorial, involving environmental triggers in genetically susceptible individuals. Evolving socioeconomic and environmental factors may be altering the contemporary aetiological and precipitant spectrum of IgAV. Prospective observational studies are therefore crucial for elucidating disease management, prognostic factors and long-term outcomes. Although numerous studies exist on paediatric IgAV, prospective cohort data remain limited. This multicentre prospective observational study aims to characterise the natural history, aetiological/precipitant spectrum, incidence and outcomes of gastrointestinal and renal involvement, factors influencing therapeutic efficacy and the predictive value of biomarkers for disease activity.

Methods and analysis

We will recruit 478 paediatric patients with newly diagnosed IgAV across multiple centres. Participants will undergo prospective longitudinal assessment at disease onset and at 1, 3, 6 and 12 months postdiagnosis. Standardised evaluations will include clinical manifestations, physical examinations, laboratory parameters and patient-reported outcomes. The data will be analysed statistically with SPSS software (V.27.0), adopting a significance threshold of p

Ethics and dissemination

This study has been approved by the Medical Ethics Committee of the First Affiliated Hospital of Guangxi Medical University (2024-K0480), the Ethics Committee of the First People’s Hospital of Yulin (YLSY-IRB-SR-2025060), the Medical Research Ethics Committee of the Liuzhou Workers’ Hospital (KY2024356) and the Ethics Committee of the Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region (No. (2025–1)003) and written informed consent was obtained from all the parents or guardians of the patients involved. It will be disseminated by publication of peer-reviewed manuscripts and presentation in abstract form at national and international scientific meetings.

Trial registration number

ChiCTR2500099716.

Acupuncture for preventing chemotherapy-induced peripheral neuropathy: study protocol for a randomised controlled trial

Por: Li · B.-Y. · Liu · C.-Z. · Zhou · H. · Wei · X.-Y. · Jia · J.-Y. · Wang · J. · Guo · X.-Y. · Liang · W. · Tu · J.-F. · Wang · L.-Q. · Shi · G. · Yang · J.-W. · Yang · N.-N.
Introduction

Chemotherapy-induced peripheral neuropathy (CIPN) is the most prevalent non-haematological, dose-limiting adverse event associated with platinum derivatives and taxanes. Currently, no effective prophylactic interventions for CIPN have been established. However, several studies have shown that acupuncture may alleviate symptoms of peripheral neuropathy, proposing it as a potentially effective strategy for CIPN prevention. This pilot trial will help determine the feasibility and efficacy of acupuncture for preventing CIPN. The results will provide valuable insights for designing a larger clinical trial and conducting power calculations.

Methods and analysis

This is a randomised sham-controlled trial. A cohort of 60 patients scheduled to receive chemotherapy will be enrolled and randomly assigned to either the electroacupuncture group or the sham acupuncture group. Eligible patients will receive nine treatment sessions administered over the course of three chemotherapy cycles. The primary outcome is the change in CIPN-related quality of life (QOL) measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) CIPN20 from baseline to the end of cycle three. Secondary outcomes include: neurotoxicity symptoms assessed by the Numeric Rating Scale, incidence of CIPN, chemotherapy status, insomnia symptoms measured by the Insomnia Severity Index, depression symptoms evaluated using the Beck Depression Inventory-II, anxiety symptoms assessed with the Generalised Anxiety Disorder-7 and fatigue symptoms measured by the Brief Fatigue Inventory. Adverse events will be meticulously recorded.

Ethics and dissemination

The study protocol (V.1.0, 29 July 2024) has been approved by the First Affiliated Hospital of Zhengzhou University (2024-KY-0853–001). All patients will provide oral informed consent and written informed consent before participating in this study. Trial results will be disseminated in peer-reviewed publications.

Trial registration number

ITMCTR2024000390 (International Traditional Medicine Clinical Trial Registry, http://itmctr.ccebtcm.org.cn/zh-CN/Home/ProjectView?pid=16387992-8971-4218-9cd0-b623af91f9f3), registered on 3 September 2024.

Clinical efficacy of meridian differentiation acupuncture in the treatment of intractable insomnia based on objective data: a protocol for a multicentre, single-blind, randomised controlled trial

Por: Chu · W. · Gao · L. · Li · Y. · Gao · X.-Y. · Guo · X. · Zhang · B.-Y. · Lin · N. · Li · B. · Dong · L.
Introduction

Insomnia, a prevalent sleep disorder, significantly impacts individuals' physical and mental well-being. Despite conventional treatments, some patients experience persistent insomnia. Acupuncture, a safe complementary therapy, has been demonstrated to be effective in treating insomnia. Meridian differentiation can enhance acupuncture efficacy by enabling individualised diagnosis. Previous clinical research has indicated that meridian differentiation acupuncture (MA), based on objective data, can notably enhance sleep quality in patients with intractable insomnia. However, small sample sizes and a lack of objective measures necessitate further investigation. Therefore, we plan to conduct a large-scale, multicentre clinical trial to validate its efficacy.

Methods

We propose a multicentre, single-blind, randomised, sham acupuncture (SA)-controlled trial involving 489 participants with intractable insomnia. Patients will be randomly assigned to three groups at a 1:1:1 ratio: the MA group, the conventional acupuncture group and the SA group. We will assess Pittsburgh Sleep Quality Index scores, actigraphy, sleep diary, Insomnia Traditional Chinese Medicine Symptom Scale scores, Hamilton Rating Scale for Anxiety scores and meridian imbalance values at baseline, after 2 weeks and 4 weeks of treatment, and at two follow-up periods (8 weeks and 12 weeks postbaseline). The intention-to-treat principle will be applied to analyse the data, observe differences between meridian differentiation acupuncture, CA and SA in improving outcomes related to intractable insomnia.

Ethics and dissemination

The study protocol has been approved by the Ethics Committee of the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine (2024HL-002) and the ethics committees of other participating institutions. Each participant must provide their written informed consent form before enrolling in this study, and consent can be withdrawn at any stage. On completion of the study, the results will be published in a journal or made available by contacting the corresponding author via email.

Trial registration number

This study protocol was registered in the Chinese Clinical Trial Registry on 22 April 2024 (ChiCTR2400083323).

Relationship between sleep characteristics and aortic aneurysm/dissection: a two-sample Mendelian randomisation study

Por: Zeng · Y.-F. · Wei · X.-Y. · Wang · Q.-G. · Qi · Z. · Li · J. · Cheng · Q. · Zeng · W. · Dong · A.
Objective

The causal relationship between sleep characteristics and aortic aneurysm and dissection (AAD) is little known.

Methods

In this two-sample Mendelian randomisation (MR) study, we selected seven sleep-related traits (sleep duration, getting up in the morning, chronotype, nap during day, insomnia, snoring, and narcolepsy) from published genome-wide association study (GWAS)-related genetic variants as instrumental variables. Causality was assessed by two-sample MR analysis using inverse-variance weighting (IVW), MR-Egger regression, weighted median, weighted mode and simple model. Horizontal pleiotropy was tested using MR-Egger regression and MR-polytropic residuals and outliers, and heterogeneity was calculated by Cochran’s Q test.

Results

There was no evidence of causality among sleep duration (IVW: OR=0.759, 95% CI: 0.489 to 1.177, p=0.218), getting up in the morning (IVW: OR=1.148, 95% CI: 0.768 to 1.716, p=0.502), chronotype (IVW: OR=0.960, 95% CI: 0.796 to 1.158, p=0.670), nap during day (IVW: OR=1.248, 95% CI: 0.771 to 2.020, p=0.367), sleeplessness/insomnia (IVW: OR=1.280, 95% CI: 0.678 to 2.414, p=0.447), snoring (IVW: OR=0.963, 95% CI: 0.770 to 1.203, p=0.738), narcolepsy (IVW: OR=1.025, 95% CI: 0.367 to 2.863, p=0.962) and aortic aneurysm. Moreover, there was no evidence to suggest a causal relationship among sleep traits and abdominal aneurysm, thoracic aneurysm and aortic dissection. Sensitivity analyses, including leave-one-out, horizontal pleiotropy and heterogeneity tests, indicated that our results were robust and reliable.

Conclusions

Overall, our study found no genetic evidence of a causal relationship between sleep characteristics and AAD. Large-scale randomised controlled trial experiments are also needed to further verify the causal relationship between sleep and AAD.

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