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.
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.
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.
ChiCTR2500097169.
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.
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.
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.
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.