Trials最新文献

Background: Peripheral nerve injuries (PNI) commonly result in multiple dysfunctions in clinical practice. Repetitive peripheral magnetic stimulation (rPMS) and repetitive transcranial magnetic stimulation (rTMS) are non-invasive interventions for neuromodulation. Their benefits have been reported respectively in PNI rehabilitation, but little is known about their combined effect. Combined central-peripheral interventions were found to have better improvements than central- or peripheral-only intervention in numerous studies. Hence, we conducted a randomized controlled trial to assess the effect of rPMS combined with rTMS on postoperative median nerve injury (PMNI) and explore its mechanism.

Methods: In this prospective, single-center, randomized clinical trial, we will enroll 60 participants with PMNI and randomize them into four groups (conventional intervention group, rPMS + sham rTMS group, sham rPMS + rTMS group, and rPMS + rTMS group) at a 1:1:1:1 ratio. All participants will undergo interventions for 12 weeks and be assessed at 0, 6, and 12 weeks during the treatment. Measurements will include grip strength, side pinch, Semmes-Weinstein monofilament test (SW), two-point discrimination test (2PD), Purdue pegboard test (PPT), motor conduction velocity test (MCV), and sensory conduction velocity test (SCV). Moreover, functional near-infrared spectroscopy (fNIRS) will be used to explore brain mechanisms. Statistical analysis will be performed using SPSS software with the significance level set at p < 0.05.

Discussion: The results of this study will develop innovative magnetic stimulation techniques for the rehabilitation of PMNI.

Trial registration: This study prospective protocol was approved by the Medical Ethics Committee of Shanghai Jing'an District Central Hospital (ethical approval number 202437, study protocol version 1.0). The trial was prospectively registered at the Chinese Clinical Trial Registry on December 16, 2024, with the name "Effects of Repetitive Transcranial Magnetic Stimulation Combined with Repetitive Peripheral Magnetic Stimulation on Complete Postoperative Median Nerve Injury: Protocol of A Randomized Control Study" (registration number ChiCTR2400094038).

Background: Prostate cancer is the second most common cancer among men worldwide and is frequently managed with robot-assisted radical prostatectomy (RARP). Standard patient positioning during RARP, specifically the lithotomy and steep Trendelenburg positions with a head-down angle of 25°-45°, can lead to complications such as peripheral nerve injury, elevated intraocular pressure (IOP), dizziness, nausea, and vomiting. This study introduces an alternative "Z-shaped supine position," aimed at reducing postoperative position-related complications and improving patient comfort.

Methods: This single-center, randomized controlled trial will recruit 78 patients scheduled for RARP. Participants will be randomly assigned to either the standard RARP position group or the Z-shaped supine position group. The Z-shaped supine position involves 10°-15° hip flexion, 5°-10° knee flexion, and 20°-30° leg abduction, combined with a 20°-25° Trendelenburg tilt. This position is supported by an integrated shoulder and neck brace. Outcomes include the incidence of peripheral nerve injuries (primary outcome), intraoperative IOP, skin contact pressure, deep vein thrombosis, postoperative pain, and pressure injury. Assessments will be conducted preoperatively, intraoperatively, and postoperatively at multiple time points. Statistical analyses will include an intention-to-treat (ITT) approach and comparisons between the two groups.

Discussion: This study aims to validate the Z-shaped supine position as a safer alternative to standard positioning during RARP, with a focus on reducing perioperative complications while maintaining both functional and surgical outcomes.

Trial registration: Chinese Clinical Trial Registry ChiCTR2300072954. Registered on 28 June, 2023.

Trial Forge Guidance 2 helps trial teams decide if another Study Within A Trial (SWAT) is needed to answer an existing research question. Five criteria are listed to assist decision-making. We are adding a sixth criterion, the Value of Information, to additionally consider the potential time and financial constraints of improving trial process evidence. The Value of Information criterion assesses each trial process based on its value of additional research and value of implementation. We consider evaluations of recruitment and retention strategies as exemplars of how such an approach could be applied to randomised evaluations of trial processes via SWATs. We applied the Value of Information Analysis to all recruitment strategies and categorised them according to their expected benefits in terms of improved recruitment, as well as the level of statistical uncertainty compared to other recruitment strategies. The same approach was followed for retention strategies. To support its use, we have developed an electronic tool that calculates and presents the criterion results for each available evaluation of recruitment and retention strategies. This will enable trial teams to apply the Value of Information criterion, along with the five existing criteria of Trial Forge Guidance 2, when deciding if further SWATs should be prioritised for a particular trial process strategy to provide evidence for the strategy's use, or not during a trial.

Background: Common mental health conditions (CMHCs) such as depression and anxiety often co-occur with noncommunicable diseases (NCDs) like hypertension and diabetes, compounding disability and mortality particularly in low- and middle-income countries (LMICs), with under-resourced health systems. This comorbidity is driven by shared behavioral risk factors including stress, isolation, tobacco use, inactivity, poor diet, and nonadherence to treatment. The World Health Organization recommends evidence-based stress reduction (EBSR), behavioral activation (BA), and motivational interviewing (MI) to address these modifiable risks, but the implementation of such multi-component behavioral interventions in community-based settings remains limited. There is a critical gap in implementation research on how best to deliver these combined interventions through community health workers (CHWs) within public health systems. This study addresses that gap by evaluating the effectiveness, implementation, and scalability of the BEhavioral Community-based COmbined Intervention for MEntal health and noncommunicable diseases (BECOME). The trial assesses clinical outcomes, implementation outcomes using the Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) framework at patient, provider, and health system levels and conducts a comprehensive costing analysis to inform future scale-up.

Methods: This is a stepped-wedge cluster randomized controlled trial involving 20 geographic clusters across two provinces of Nepal and 700 participants aged 40 years and above with at least one CMHC and one NCD. CHWs will be trained to deliver BECOME, comprising EBSR, BA, and MI, while the control period will include enhanced usual care. Primary outcomes include changes in CMHC severity and secondary outcomes include NCD outcomes, behavioral factors, and implementation processes. Focus group discussions and in-depth interviews with CHWs, patients, healthcare providers, and health system leaders will explore intervention acceptability and mechanisms of change. Structured costing analysis will estimate the intervention costs.

Discussion: Participant recruitment began in July 2024 and is currently ongoing. We anticipate completing data collection for the primary outcome measures by January 2027, with the aim of disseminating preliminary findings within the same year. Findings from this study will provide evidence on the effectiveness and feasibility of a CHW-delivered, integrated behavioral intervention, BECOME, for CMHCs and NCDs in LMICs, informing potential scale-up.

Trial registration: ClinicalTrials.gov, NCT06449521, Registered on 25 April 2024, https://register.

Clinicaltrials: gov/prs/beta/studies/S000DZJN00000112/recordSummary .

Background: Poststroke cognitive impairment (PSCI) significantly reduces quality of life and survival rates. Current interventions face challenges in efficacy and accessibility. Noninvasive brain-computer interface (BCI) technology may enhance neural plasticity and cognitive recovery through real-time neurofeedback, offering a safe and accessible approach for poststroke cognitive rehabilitation. This trial aims to evaluate the efficacy of BCI-based cognitive training and explore its neural mechanisms.

Methods: A prospective, randomized, double-blind, controlled, single-center trial will enroll 66 PSCI patients. Participants will be randomized into the intervention group or control group. Interventions will be administered 5 days/week for 4 weeks. Primary outcome is as follows: The 4-week post-intervention MoCA scores; secondary outcomes are as follows: 3-month follow-up MoCA scores, attention, memory, executive function, neurophysiological markers, and daily living function. Assessments will be conducted at baseline (T_0W), post-intervention (T_4W), and 3-month follow-up (T_16W).

Discussion: Results will provide evidence for BCI's clinical utility and neuroplasticity mechanisms, guiding personalized neurorehabilitation strategies.

Trial status: The protocol version used for this study is Version 3.0, dated May 8, 2025. Recruitment is scheduled to begin on June 10, 2025, and is expected to be completed by May 8, 2026.

Trial registration: Chinese Clinical Trial Registry ChiCTR2500107318. Registered on 8 August 2025.

Background: The use of electronic consent (eConsent) in clinical research studies is on the increase and has been since 2019. eConsent itself can be multi-faceted, encompassing documentation of the consent process, delivering information to the potential participant via the use of different media, and even facilitating a check of the participants' understanding of the research before they enter a study. Some researchers and research teams have embraced the use of the different aspects of eConsent, whilst other groups/teams are hesitant to employ the methodology until it has been proven and fits better with workflows and patient pathways.

Main text: We report on how eConsent has been utilised in 35 studies from a large academic clinical trials unit in the UK, with nearly 12,000 participants being consented using this methodology via the REDCap data collection system over a 6-year period. The studies utilising eConsent have all made use of the documentation facet of eConsent, with some studies also making use of different media to provide information to the potential participant. The use of these methods has been adopted by the majority of our open studies and all but one of the research delivery teams across the whole CTU portfolio. To facilitate some of the processes that need to be implemented, two external modules have been written for REDCap to make the process easier. Many of our studies also make use of the facility to enable remote eConsent (i.e. where the potential participant and researcher are not physically in the same place), and very few studies in our portfolio now require paper consent forms as either an alternative option or as a backup in case the electronic systems are not available. This has resulted in a reduction in the amount of paper that needs to be provided, resulting in a decrease in the carbon footprint of the studies.

Conclusions: We have successfully utilised eConsent techniques to receive informed consent from nearly 12,000 participants in a multitude of clinical trials recruiting individuals from age 8 to 80. Half of these trials also used eConsent to facilitate both the documentation and the discussion around the consent process. Where remote eConsent has been used, techniques have been employed to make the process easier on the participant and the researcher, whilst not detracting from the two-way conversation that is important for the consent process.

Background: Postoperative pulmonary complications (PPCs) are severe and are of particular concern in older adult patients undergoing laparoscopic gastrointestinal surgery. Both 40% and 80% fraction of inspired oxygen (FiO₂) are commonly used for anesthesia. Presently, whether 40% FiO₂ can increase the oxygenation index of patients 48 h postoperatively and reduce PPCs remains controversial. Moreover, no clear consensus exists for older adult patients. Therefore, this study aims to compare the effects of low FiO₂ (40%) and high FiO₂ (80%) levels on postoperative pulmonary function in older adult study participants undergoing laparoscopic gastrointestinal surgery.

Methods: This multicenter, prospective, parallel-cohort, randomized controlled clinical trial will include 1098 older adult participants aged ≥ 65 years old undergoing laparoscopic gastrointestinal surgery, from 16 clinical trial sites across China. Participants will be randomized, as per a 1:1 ratio to two cohorts, the "L" and "H" cohorts, to receive low FiO₂ (40%) and high FiO₂ (80%) levels, respectively. The primary outcome measure is the 48-h postoperative oxygenation index between the two cohorts. The secondary outcome measures include the other blood gas analysis results, PPCs within 7 days, and 30-day mortality rate.

Discussion: This study of elderly patients undergoing laparoscopic gastrointestinal surgery with different intraoperative oxygen concentrations at high risk for pulmonary complications. All subjects were followed up for up to 30 days for pulmonary function, postoperative complications, etc. Randomization was performed separately at 16 sites.

Trial registration: ClinicalTrials.gov NCT06359106. Registered and posted on April 11, 2024.

Background: Succinylcholine is favored for its rapid onset and offset, but its use is limited by adverse effects. Mivacurium chloride, a non-depolarizing relaxant, offers a similar shorter duration and fewer cardiovascular effects, especially without worrying about muscle pain and hyperkalemia, making it a potential alternative in some short-time operations. This study aims to assess the non-inferiority of mivacurium chloride compared to succinylcholine in terms of muscle relaxation effect and safety during flexible bronchoscopy.

Methods: This is a prospective, single-center, randomized, assessor-blinded, positive-controlled trial. Participants scheduled for flexible bronchoscopy requiring muscle relaxation were randomly assigned to receive either mivacurium chloride or succinylcholine. The primary endpoint is the recovery rate of spontaneous breathing within 15 min after discontinuation of muscle relaxants. Other outcomes, including recovery time at different levels, hemodynamic changes, adverse events, and satisfaction from physicians and patients, are also collected.

Discussion: This study aims to compare the recovery effect of mivacurium chloride for muscle relaxation during bronchoscopy with succinylcholine, hypothesizing that mivacurium chloride is non-inferior in recovery time and superior in safety and comfort.

Trials registration: Chinese Clinical Trial Registry ChiCTR2400091276. Registered on 23 October 2024.

Clinicaltrials: gov NCT06709066. Posted on 29 November 2024.

Background: Body dissatisfaction is highly prevalent in Latin America, including Colombia. However, culturally adapted, evidence-based interventions are lacking, although effective programs exist in Western countries. This protocol describes a cluster randomized controlled trial (cRCT) of an intervention to improve media literacy and decrease body dissatisfaction and related outcomes among adolescents in urban and rural schools in Colombia.

Methods: We will recruit 1250 adolescents in 7th-10th grade (aged 11-17 years) to participate in a two-arm, cluster-randomized, open-label, controlled superiority trial in Colombia. Participating schools will be recruited by the research team. Participants will be randomized at the school level (1:1). Randomization blocks stratified by socioeconomic status (high vs. low) and geographical area (rural vs. urban) will be used to assign schools to either: (a) a school-based, four-session group intervention delivered over 2-4 weeks by trained facilitators (n = 625) or (b) a waitlist control group that will receive the intervention only after follow-up (n = 625). Participants need to be aged 11-17 years old, attending a participating school and class in grades 7 to 10, have written parental consent, and give written assent to be eligible for participation in this study. Individuals who cannot understand spoken or written language, or who do not have parental consent to participate, will be excluded. Primary outcomes are media literacy and body dissatisfaction. Secondary outcomes include appearance comparison, thin ideal internalization, curvy ideal internalization (girls only), drive for muscularity (boys only), eating disorder symptoms, and general wellbeing. Additional exploratory outcomes include risky appearance-altering behaviours (girls only), colourism, and skin colour satisfaction. Furthermore, adverse outcomes will be recorded. Outcome assessments will happen pre-intervention (baseline; Timepoint 1), 1-week post-intervention (immediate post-test; Timepoint 2), and 9-12 months post-intervention (follow-up; Timepoint 3).

Discussion: Based on pilot data, we hypothesise that the intervention group will demonstrate increased media literacy and decreased body dissatisfaction at post-test and follow-up. We also anticipate improvements in secondary outcomes. This will be the first cluster RCT to evaluate the effect of a culturally adapted body image intervention in Colombia. This trial has been registered in the ISRCTN Registry (ISRCTN15802562, https://doi.org/10.1186/ISRCTN15802562 ). First enrolment was on 26th of August 2025.

Trial registration: This trial has been registered in the ISRCTN Registry (ISRCTN15802562, https://doi.org/10.1186/ISRCTN15802562 ).