Outcomes for degenerative cervical myelopathy (DCM) patients are limited by delayed and missed diagnoses, driven in part by poor professional awareness. Despite DCM being the most common cause of adult spinal cord injury, it remains under-recognised and undertaught in clinical education. Lessons from other common pathology like stroke and acute myocardial infarction highlight the potential of education to improve early diagnosis. This study will develop a professional education strategy to improve early DCM diagnosis. It will define key audiences and identify an effective delivery method, laying the groundwork for a sustained, targeted intervention.
The study aims to define who needs to know about DCM, what they need to know and how they can learn it. This will be carried out in three phases: phase 1—who and what: to establish the target population and to define core competencies for the educational intervention; phase 2—how: to create and review the educational intervention; phase 3—evaluation: to test whether the framework is an improvement to existing strategies.
Ethical approval is in place from the University of Cambridge (HBREC.2024.24). Results from the study will be disseminated through scientific publication, conference presentation, blog posts and podcasts.
CRD42023461838
Preoperative anxiety is prevalent among neurosurgical patients and is associated with adverse clinical outcomes. Virtual reality (VR) technology offers an innovative approach to delivering immersive preoperative education, particularly in familiarising patients with the intensive care unit (ICU) environment. This study aims to evaluate whether a VR-based ICU orientation can reduce perioperative anxiety and improve psychological preparedness in adult neurosurgical patients.
This single-centre randomised controlled trial plans to enrol 108 patients at Xuanwu Hospital. Using a computer-generated random sequence, participants will be randomly assigned in a 1:1 ratio to two groups: a control group receiving standard preoperative guidance, and an experimental group receiving standard guidance plus a VR-based ICU experience tour conducted 1 day before surgery. The primary outcome measure is the incidence of anxiety within 24 hours before discharge from the ICU. Secondary outcome measures include the incidence of depression, cognitive impairment and delirium, duration of delirium, safety events and other clinical outcomes. Data collection points include baseline (T0), 24 hours before surgery (T1), during ICU stay (T2) and 30 days after discharge (T3). All data analyses will be performed using SPSS V.26.0 software and will follow the intention-to-treat principle. This study seeks to determine the effectiveness of a VR-based ICU experience tour in reducing perioperative psychological stress and improving postoperative clinical outcomes.
This study was approved by the Ethics Committee of Xuanwu Hospital, Capital Medical University (Approval ID: (2024) NO.152-002). The initial approval was obtained on 4 July 2024, and remains valid through 4 July 2026. All participants will provide written informed consent before any data collection takes place. The research findings are intended to be disseminated through publication in peer-reviewed scientific journals.
ChiCTR2400093170.
Cerebral amyloid angiopathy (CAA) is caused by the accumulation of amyloid-beta (Aβ) in the cerebrovasculature. The glymphatic system is thought to be involved in the clearance of cerebral waste products, including Aβ. Stimulation of the glymphatic system through enhancing deep sleep with low-sodium oxybate (LXB) or inhibition of cortical spreading depolarisations via non-invasive vagus nerve stimulation (nVNS) could potentially increase clearance of Aβ and hence improve disease course.
We will perform a pre-post trial to assess whether treatment with LXB, nVNS or a combination of both interventions can enhance the clearance of Aβ in patients with CAA. A total of 60 participants, 30 with sporadic CAA and 30 with Dutch-type CAA, will be randomly assigned to receive either LXB, nVNS or both interventions, resulting in three groups (20 in each group: LXB, nVNS and both). The study spans 6 months, comprising a 3-month observational phase and a 3-month intervention phase. The primary outcome measure will be the morning levels of Aβ40 and Aβ42 in cerebrospinal fluid (CSF) before and after the intervention. We will assess possible disease progression with (non-)haemorrhagic imaging markers on 7-Tesla MRI at baseline, before and after intervention, as a secondary outcome. Additionally, the activity of the glymphatic system by means of fluid dynamics will be assessed with CSF-Selective T2-weighted Readout with Acceleration and Mobility encoding (CSF-STREAM) on 7-Tesla MRI.
The study was reviewed and approved by the Medical Research Ethics Committee Leiden The Hague Delft (P23.100) on 8 April 2024. The first participant was enrolled on 27 March 2025. Study results will be published in peer-reviewed journals and presented at scientific conferences. Additionally, study updates and results will be shared with participants via our newsletter twice a year.
EU CT number 2023–5 06 128-10-00, Universal Trial Number U1111-1295-1113, ClinicalTrials.gov NCT06421532.
Intracranial atherosclerotic stenosis (ICAS) is a leading cause of ischaemic stroke, particularly among Asian populations, and continues to impose a significant burden across the region. Despite this, evidence from Asia remains fragmented. Findings from our previously conducted scoping review revealed an absence of standardised diagnostic criteria and imaging protocols. This resulted in marked methodological inconsistencies in regional ICAS research, thereby limiting the validity and interpretability of existing data. To address this, we have initiated a consensus process that aims to establish standardised definitions, develop harmonised diagnostic protocols and outline research standards and priorities for ICAS across Asia.
A modified Delphi approach will be employed to formulate consensus-based recommendations through a structured, iterative, multistage process. Draft Delphi statements will be informed by targeted literature reviews and formatted into five-point Likert scale questionnaires with fields allowing for qualitative feedback. An expert core group was selected based on their established clinical and research expertise in intracranial atherosclerosis, cerebrovascular imaging and stroke, with deliberate consideration for geographic and disciplinary diversity. This group will serve as the formal voting panel. The process will comprise three to four anonymous online rounds, with a predefined consensus threshold of ≥80% agreement. Statements that do not reach consensus will be revised based on aggregated feedback and re-evaluated in subsequent rounds. A non-voting hybrid conference, open to the public, will follow the second round to facilitate broader engagement and discussion; relevant points will be incorporated into the subsequent round. Consensus on research standards and priorities will follow the finalisation of recommendations on standardised definitions and harmonised diagnostic protocols to ensure alignment with preceding outcomes.
This consensus was granted exemption by the Jose R. Reyes Memorial Medical Center Institutional Review Board (No. 2025–221). Resulting recommendations will be disseminated through peer-reviewed publication and presentation at scientific fora.
Depression is a common complication of stroke that adversely affects functional recovery. Although a wide range of pharmacological and non-pharmacological interventions are used in clinical practice, evidence regarding their comparative efficacy and acceptability remains inconclusive. Therefore, we will conduct the first systematic review and network meta-analysis (NMA) to compare and rank available interventions for post-stroke depression (PSD).
The findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. In this systematic review and network meta-analysis, we will search PubMed, EMBASE, Cochrane Central Register of Controlled Trials, PsycINFO, CINAHL, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform from database inception to 1 September 2025 to identify published and unpublished randomised controlled trials (RCTs). We will include studies comparing pharmacological and non-pharmacological treatments, or any control conditions as monotherapy for the treatment of patients with PSD. We will assess the certainty of evidence using the Confidence in Network Meta-Analysis framework. The primary outcomes will be the change score on depression scales from baseline to the end of treatment (efficacy) and all-cause discontinuation (acceptability). Secondary outcomes will include quality of life, cognitive and neurological function scores, anxiety and sleep quality. Two reviewers will independently screen and select eligible studies based on predefined inclusion and exclusion criteria. Risk of bias in all RCTs included in the NMA will be assessed using the revised Cochrane Risk of Bias tool (RoB 2). A frequentist NMA will be conducted in Stata and R. Meta-regression and sensitivity analyses will be performed to assess robustness.
This NMA does not need ethical approval, as the data used here are based on aggregated data in the public domain. Findings from the analysis will provide an overview and information on the relative efficacy and acceptability of non-pharmacological and pharmacological treatments in PSD. The results will be disseminated through peer-reviewed publication.
CRD420251136670
Some people with HIV (PWH) experience brain changes that affect neurocognition, but little is known about how HIV impacts social cognition or related brain regions. Social cognition, the ability to perceive, understand and respond to social information, is important for maintaining relationships and quality of life. This article provides the protocol for the first comprehensive study examining social brain function in PWH and people without HIV (PWoH). With three aims, this study will: (1) examine neural circuits related to social cognition; (2) examine social cognitive performance across two social cognitive domains and (3) examine the role of social cognition in everyday social functioning.
Referred to as Social Brain Health Study in HIV Study, this cross-sectional study will enrol 105 PWH and 105 demographically matched PWoH aged 18–65 years. The study administers a comprehensive assessment battery across two visits within a 2-week period. Visit 1 includes behavioural measures of social cognition (Perceiving Social Cues and Understanding Others), neurocognition and social functioning (social network size and loneliness). Visit 2 involves functional MRI procedures with three social cognitive tasks designed to activate key brain regions (ie, fusiform face area, superior temporal gyrus, temporo-parietal junction, dorsal medial prefrontal cortex).
This study was funded by the National Institute of Mental Health (MH139613) and approved by the Institutional Review Board of the University of Alabama at Birmingham (IRB-300013394). Data collection is ongoing. The first results are expected to be submitted for publication in 2030. Findings of this study will be published in peer-reviewed journals and presented at local, national and international conferences as well as patient organisations such as AIDS service organisations and community talks.
Stroke is one of the top causes of disability in Malaysia, yet caregivers have limited access to structured, culturally tailored education to support poststroke care.
To develop and validate the CaknaStrok Education Package (CEP), a blended learning intervention comprising a printed guidebook and a trilingual mobile health application for informal stroke caregivers in Malaysia.
Methodological study involving the development and validation of a caregiver education programme guided by the Analyse, Design, Develop, Implement, Evaluate (ADDIE) instructional design framework.
Development and validation were conducted in Malaysia between January 2022 and December 2023. Both experts and caregivers were recruited from two tertiary hospitals on the East Coast of Malaysia, with caregivers identified from inpatient wards and outpatient clinics at these hospitals.
Content validation involved 10 multidisciplinary experts. Face validation involved 14 informal stroke caregivers who met eligibility criteria, and all completed the study.
CEP was developed based on prior needs assessment and expert input. Content validation was undertaken using the Content Validity Index (CVI) and face validation using the Face Validity Index (FVI), both assessed on a four-point Likert scale. Qualitative feedback was also obtained from the participants.
CEP consists of six modules delivered via a printed guidebook and a trilingual app with videos, assessment tools and local resources. Experts rated the content highly valid (Scale-level (S)-CVI/the average method (Ave): 0.97–0.99 across domains). Caregivers reported strong acceptability (S-FVI/Ave: 0.95–0.99). Qualitative feedback from experts and caregivers informed refinements to content clarity, usability and presentation, including improved navigation, consistent language use and enhanced visual design. Suggestions requiring substantial structural changes were documented for future iterations.
The CEP shows strong content and face validity as a blended caregiver education tool. By combining printed and digital formats, CEP addresses cultural and access challenges and provides a scalable model for stroke caregiver education in Malaysia. Further pilot or feasibility studies are warranted to evaluate usability, engagement and implementation in real-world settings prior to effectiveness evaluation.
Anxiety is a common non-motor symptom of Parkinson’s disease (PD). There is no specific pharmacological intervention for people with PD who experience anxiety. Current non-pharmacological treatments have mixed or inconclusive results and there does not appear to be a non-pharmacological intervention for people with PD disease and anxiety that focuses on activity and participation.
To co-produce an occupation-focused complex intervention to help people with PD live well with anxiety that community-based occupational therapists can deliver.
Six-stage complex intervention development was conducted using online logic modelling and a participatory approach to organise the new intervention’s key inputs, processes and outcomes important to people with PD living with anxiety.
Data were collected via online logic modelling sessions involving people with Parkinson’s, care partners and occupational therapists across the UK from April 2022 to June 2022.
34 participants were recruited (people with PD n=14, care partners n=9, occupational therapists n=11) for the online logic modelling sessions.
Resources to support the new intervention (‘inputs’) include adequate resourcing, education for professionals and people with PD, flexibility of delivery methods and goal setting. The intervention’s actions to produce outcomes (‘processes’) should include 1:1 support, lifestyle management, providing meaningful information, collaborative goal setting, therapeutic use of everyday activities, and involvement of friends and families. The intended results (‘outcomes’) should include a reduction in anxiety symptoms, people with PD enjoying more meaningful activities, increased understanding of anxiety and PD, improvement in clinical outcomes and improvement of service-level outcomes. These key aspects were incorporated into an intervention manual, educational material and training video.
We have systematically coproduced a new occupation-focused complex intervention to help people with PD to live well with anxiety. This provides the basis for the next project in which this intervention will be tested for feasibility.
The study evaluated the feasibility and efficacy of a non-immersive virtual reality (VR) system on upper extremity (UE) recovery in ischaemic stroke patients in comparison to a conventional physiotherapy.
An open-label, parallel-group, randomised controlled trial randomly assigned the participants to two groups, VR intervention or conventional physiotherapy.
Two tertiary stroke care centres in South India participated in the study.
Sixty first-ever ischaemic stroke patients (1–6 months of stroke onset) having spasticity grades of 1 or 1+ as per Modified Ashworth scale and Brunnstrom recovery stages of 3, 4 or 5 in the UE were included in the intention-to-treat analysis.
High-intensity non-immersive VR-based comprehensive rehabilitation gaming system with a duration of 12 weeks (3 days/week) was compared with equally intensive conventional physiotherapy.
The feasibility outcome was the compliance with the treatment. The primary efficacy outcome was the improvement in the motor function assessed by the Fugl-Meyer assessment (FMA) and Wolf motor function test (WMFT). The secondary outcomes included the performance in activities of daily living by the Barthel index (BI) and the quality of life by the 36-item short form health survey (SF-36).
The treatment compliance was similar in two groups (p=0.19). Both groups improved in motor performance, activities of daily living and quality of life. However, there were no significant differences in the FMA (p=0.58), WMFT (functional ability scale, p=0.33; performance time, p=0.44), BI (p=0.84) and SF-36 (physical, p=0.87; mental, p=0.99) scores between the groups.
The non-immersive VR system was feasible, effective and safe; however, it was not found to be superior to conventional physiotherapy. The trial was stopped early and did not reach its proposed sample size and hence, the findings are to be interpreted cautiously.
Clinical trial registry India: CTRI/2021/11/038339 (https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NTc1OTI=&Enc=&userName=CTRI/2021/11/038339).
Alcohol consumption is an increasingly recognised modifiable risk factor for dementia, yet whether it has differential impacts on dementia subtypes and its role in disease progression remains unclear. This study aims to: (1) quantify the association between alcohol intake and incidence of dementia subtypes and (2) examine whether individuals who drink heavily and develop dementia referred to hereafter as ‘alcohol-related’—have poorer post-diagnosis outcomes compared with other dementia cases. Clarifying these relationships will determine whether alcohol selectively increases risk for specific dementia phenotypes or broadly heightens neurodegenerative vulnerability, with implications for prevention, clinical counselling and therapeutic targeting.
This population-based cohort study of alcohol and dementia will use linked UK electronic health records from Clinical Practice Research Datalink, Hospital Episode Statistics and Office for National Statistics (ONS). Participants will be eligible if they have available linked data from January 1998, when ONS death registrations became available, until the end of follow-up. Alcohol exposure will be defined through self-reported recorded weekly alcohol units and diagnostic codes for harmful or dependent alcohol use. Primary outcomes including incident all-cause and subtype-specific dementia (eg, Alzheimer’s, vascular, Lewy body, Parkinson’s, frontotemporal) as well as secondary outcomes (ie, mortality, care-home entry and neuropsychiatric symptoms). Key covariates encompassing socio-demographic factors, smoking and relevant comorbidities will be adjusted for. Multivariable Cox proportional hazards and Fine-Gray competing risk models will estimate associations with dementia incidence. Post-diagnosis prognosis will be compared for dementia in individuals with a history of heavy alcohol use (‘alcohol-related’) and dementia in individuals with minimal alcohol exposure (‘non-alcohol-related’) cases using survival and logistic regression models. Multiple testing correction will be applied across dementia subtype comparisons. Alcohol exposure will be modelled continuously and non-linearly using restricted cubic splines and categorically using binary indicators of harmful/dependent use. Missing covariate data will be assessed and addressed using appropriate methods, including multiple imputation and complete-case analysis. Data extraction and analysis are scheduled from October 2025 to October 2026.
Use of de-identified routine data will proceed under existing Research Ethics Committee and data governance approvals. Findings will be disseminated via open-access peer-reviewed journals, academic conferences and summaries targeted at patient, public and policy audiences. The results of this study will be reported according to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) guidelines.
To explore experiences of healthcare providers, stroke survivors and caregivers on stroke transitional care delivery at a tertiary hospital in Tanzania.
A qualitative descriptive design with a phenomenological approach was used. Colaizzi’s thematic analysis was conducted using Dedoose software to identify significant information that describes the transitional care experiences of the study participants.
This study was conducted in the internal medicine and outpatient departments of a tertiary hospital in Tanzania.
15 triads of healthcare providers, stroke survivors and caregivers were purposively recruited to participate in semi-structured in-depth interviews between June and September 2024.
The analysis identified four themes: communication and exchange of information, involvement of patients and caregivers in transitional care, coordination of transitional care and experiences with changing care setting. Effective communication and information exchange among healthcare providers, survivors and caregivers ensured that survivors and their caregivers were well informed about the care process, clinical condition, prognosis and transitional care needs. A collaborative care approach enabled survivors and caregivers to actively participate in care, decision-making and discharge planning during hospital-to-home transition. Coordination of care was equally important during hospital-to-home transition as it provided survivors with home-care instructions and opportunities for follow-up care. However, miscommunication among the healthcare team, insufficient information exchange, inadequate discharge planning, poor social support and lack of care coordination prevented smooth hospital-to-home transition leading to a crisis at home.
The experiences of healthcare providers, patients and caregivers during stroke transitional care in Tanzania highlight achievements and key areas for improvement. Hospital-to-home transition is often characterised by uncertainty and emotional strain, emphasising the need for effective communication, involving patients and caregivers in care, as well as coordinating transitional care to address medical and psychosocial needs of survivors and their caregivers during and after discharge.
Dementia contributes to the disease burden worldwide, and people with hypertension or type 2 diabetes are at an elevated risk of developing dementia. It is essential to prevent or delay cognitive decline in people at high risk within the community. Our trials aim to evaluate the effects of adaptive cognitive training on community-dwelling older adults with hypertension or type 2 diabetes but no dementia.
Two multicentre, double-blind, randomised, placebo-controlled trials, named COgNitive Training in community-dwelling older adults at high risk for demENTia and with Hypertension (CONTENT-Hypertension) and COgNitive Training in community-dwelling older adults at high risk for demENTia and with Diabetes (CONTENT-Diabetes), will be conducted to investigate the effects of adaptive cognitive training on participants aged 60 years or above who have been diagnosed with hypertension or type 2 diabetes but no dementia. Each trial will enrol 120 participants. Participants will be recruited from the local community in Shijingshan and Haidian Districts, Beijing, and allocated to either the intervention or control group using a 1:1 ratio. The intervention group will engage in 12 weeks of adaptive cognitive training, while the control group will receive 12 weeks of placebo cognitive training. A 24-week follow-up assessment will be conducted for all participants to evaluate the persistence of the effects. The primary outcome is the 12-week change in Montreal Cognitive Assessment (MoCA) Basic scores from baseline to the end of the intervention (12 weeks). Secondary outcomes include 6-week and 24-week changes in the MoCA from baseline; 6-week, 12-week and 24-week changes in Trail Making Test-A&B (TMT-A, TMT-B), Digit Symbol Substitution Test, the WHO/University of California at Los Angeles Auditory Verbal Learning Test and Boston Naming Test scores of cognitive functions; 6-week and 12-week changes in Geriatric Depression Scale, Generalised Anxiety Disorder-7 (GAD-7), Pittsburgh Sleep Quality Index and 12-week change in blood pressure (CONTENT-Hypertension) or fasting blood glucose and glycated haemoglobin (CONTENT-Diabetes) from baseline.
This study will adhere to the ethical principles outlined in the Declaration of Helsinki and comply with international standards for Good Clinical Practice. All participants will sign the informed consent at baseline. This study has been approved by the Ethics Committee of Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (approval numbers: 2023-139 and 2024-162). The findings of the trials will be disseminated through publications in peer-reviewed scientific journals and presented at academic conferences.
Large-scale stroke registries can provide critical insights into disease mechanisms, progression and healthcare needs, informing prevention and care. However, few collect detailed demographic, brain imaging, and comprehensive long-term follow-up data. To address this, we established the prospective Stroke Investigation Group in North And central London (SIGNAL) registry in 2017.
The SIGNAL registry included 3931 adults aged ≥18 years with confirmed acute stroke (cerebral ischaemia or intracerebral haemorrhage (ICH)) admitted to the University College London Hospital hyperacute stroke unit between January 2017 and 2020, drawn from an ethnically diverse North and Central London population (~1.6 million). Baseline data included demographic, clinical, brain imaging and next-of-kin information. Six month follow-up included measures of functional status and non-motor outcomes (anxiety, depression, fatigue, sleep, pain, language, continence, social participation, cognition) via face-to-face, telephone or postal follow-up methods.
The mean age of individuals included in the SIGNAL registry was 72.1 years, and 1806 (45.9%) were female. The ethnic distribution comprised 2365 (60%) white, 649 (16.5%) black and 511 (13%) Asian. Stroke diagnoses included 3371 (85.8%) with cerebral ischaemia and 560 (14.2%) with ICH. On admission, 2240 individuals (57.0%) had a National Institutes of Health Stroke Scale score >4, indicating moderate stroke severity. At hospital discharge, the median functional outcome, measured by the modified Rankin Scale, was 3 (IQR 1–4), indicating moderate disability. At 6 months, functional outcomes measured with mRS were available for 3755 individuals (95.6%) with a median score of 1 (IQR=0–3) and non-motor outcomes were available for 3080 individuals (92.3%). The most prevalent adverse non-motor outcomes were fatigue 1756 (57%), reduced social participation 1694 (55%) and sleep disturbance 1663 (54%).
Further analyses of SIGNAL registry data will investigating associations between stroke mechanisms, subtypes and neuroimaging features and 6-month functional status, non-motor outcomes and cognitive impairment. Longer term follow-up of survivors for ~10 years is also planned.
Postherpetic neuralgia (PHN) is a debilitating complication of herpes zoster (HZ) that significantly impairs quality of life, disrupting sleep, daily activities and work capacity. Globally, PHN represents a major public health challenge, with marked heterogeneity in its epidemiological patterns across different regions and demographic groups. The escalating incidence of both HZ and PHN underscores the urgent need to elucidate modifiable and non-modifiable risk factors, which is critical for implementing targeted prevention strategies and optimising therapeutic interventions. Although previous studies have examined PHN risk factors, there remains a paucity of comprehensive, up-to-date systematic analyses evaluating its global epidemiological trends and associated determinants. This protocol presents the methodology of a planned systematic review to assess an updated global estimate of PHN epidemiology and synthesises critical risk factors associated with PHN prevalence or severity.
This systematic review and meta-analysis will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. We will search MEDLINE/PubMed, Embase, Web of Science, CENTRAL, PsycINFO, Google Scholar, CNKI, Wanfang and CBM for English/Chinese studies published from inception through April 2025. Eligible studies will include adults (≥18 years) with HZ or PHN that report PHN prevalence/incidence or relevant risk factors (eg, age, vaccination status, acute pain severity, comorbidities). Two reviewers will independently screen records, extract data (including study characteristics, demographics, risk factors and pain metrics) and assess risk of bias using Joanna Briggs Institute tools and ROBINS-I. Random-effects meta-analyses (R V.4.0) will pool PHN prevalence (logit-transformed Wilson scores) and ORs for risk factors, with subgroup analyses by geography, income level, clinical/demographic factors. Heterogeneity (I²≥50%) will trigger meta-regression or narrative synthesis. Sensitivity analyses will address bias robustness.
Ethics committee approval is not required. The results of the review will be published through an open access journal.
CRD42024510329.
The Chinese neuroimmunological disease database (NIDBase) cohort was established to explore genetic and environmental risk factors, clinical features, multi-omics data and prognostic biomarkers. The aim is to enhance our understanding of central nervous system (CNS) demyelinating diseases. Additionally, the establishment of this cohort will address the critical issue of the lack of comprehensive genetic data and biological samples for precision diagnosis and treatment research related to neuroimmunological diseases in China.
56 hospitals in various regions of China were selected to participate in this study. The patients diagnosed with CNS demyelinating diseases were recruited, including clinically isolated syndrome (CIS), multiple sclerosis (MS), neuromyelitis optica spectrum disease (NMOSD), myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and autoimmune glial fibrillary acidic protein astrocytopathy (GFAP-A).
At the time of patient enrolment, the clinical information is designated as baseline data. The collected baseline data include demographic information, disease history, clinical features of each demyelinating event, treatment records, standardised scales, questionnaire assessments and laboratory test results. Furthermore, biological samples, MRI and high-density electroencephalography (hd-EEG) data will be collected at baseline. All patients will be followed up at 3 months and 6 months and annually thereafter. As of December 2024, 3866 patients with CNS demyelinating diseases have been enrolled, including 84 CIS, 282 MOGAD, 1405 MS and 2095 NMOSD. Our findings indicate that CNS demyelinating diseases, particularly NMOSD, are more prevalent in women in China, with significant age differences observed among NMOSD patients compared with those with CIS, MS and MOGAD.
In future, all patients in our cohort will be followed up at 3 months and 6 months and then annually. By the end of December 2024, the database has been locked and is now being processed and analysed, while our data continue to be updated and expanded for further analysis. Both prospective and retrospective observations will be included in this study. Subsequent publications will emerge from this multicentre cohort, encompassing genomics, clinical cohort studies, hd-EEG biomarkers, imaging-based radiomics and electrical stimulation therapies.
By adopting the shared decision-making (SDM) model, this study aims to improve treatment adherence and patients’ subjective initiative. It intends to systematically explore the barriers and facilitating conditions for patients who had a stroke to participate in rehabilitation SDM through the analysis and integration of qualitative research methods. The ultimate goal is to provide a basis for optimising the formulation of rehabilitation plans, enhancing the quality of nursing services and improving patients’ medical experience.
The following databases were searched, with only literatures published in English or Chinese included: Cochrane Library, PubMed, Embase, Scopus, Web of Science, CNKI (China National Knowledge Infrastructure), CBM (Chinese Biomedical Literature Database) and Wanfang Database. The search covered the period from the establishment of each database to 1 March 2025. The quality of the included literatures was evaluated using the Qualitative Research Quality Assessment Tool provided by the Joanna Briggs Institute in 2016, with a focus on factors affecting participation of patients who had a stroke in rehabilitation SDM.
A total of 1502 articles were retrieved in the preliminary search, and 10 were finally included. From these included literatures, 31 findings were extracted. Similar results were categorised and grouped into 10 new categories, which were further integrated into 3 core integrated findings: (1) patient-related factors, including interference from negative emotions, the gap between rehabilitation expectations and reality, the impact of socio-demographic factors and self-efficacy with stage-specific autonomous needs; (2) family-related factors, including family support, the impact of patients’ sense of responsibility to their families on decision choices and trade-offs forced by economic burden; (3) healthcare provider and environmental factors, including paternalistic models undermining autonomy, insufficient information and difficulty in screening hindering decision-making and discontinuity in the rehabilitation system and lack of resources increasing decision-making burden.
Through the meta-synthesis of qualitative studies, this research shows that negative emotions and realistic gaps reduce patients’ participation in decision-making. While family support helps enhance patients’ confidence in decision-making, economic burden affects their decision choices. Additionally, one-way doctor–patient communication, insufficient information support and discontinuity in the rehabilitation service system increase patients’ decision-making burden.
This study assessed whether a previously developed Monte Carlo simulation model can be reused for evaluating various strategies to minimise time-to-treatment in southwest Netherlands for endovascular thrombectomy (EVT) in patients who had an ischaemic stroke.
Reuse of a previously developed simulation model to simulate various strategies in another region, using prospectively collected data from stroke centres and retrospective data from emergency medical services.
Data from 509 patients who had an ischaemic stroke (≥18 years) treated with EVT (2014–2018) were used.
Input for the simulation model reuse included distributions of observed time delays along the acute stroke pathway. Validation of the baseline models was based on face validity and statistical measures (patient data vs model output) using the Assessment of the Validation Status of Health Economic decision models tool. We simulated strategies for a subregion: interhospital patient transfer by helicopter, transport of the neurointerventionalist to the primary stroke centre (‘drive-the-doctor’), interhospital patient transfer to a thrombectomy-capable stroke centre (TSC) outside the region and prehospital triage using the Rapid Arterial Occlusion Evaluation (RACE) scale.
Onset-to-groin time was the outcome.
Reuse of the original simulation model was obtained by minimal effort, implying limited adaptation. Compared with the baseline model, interhospital patient transfer by helicopter or to a TSC outside the region and prehospital routing using the RACE scale reduced mean onset-to-groin time by 16, 13 and 39 min, respectively (95% CrI for all: equal to the point estimate). ‘Drive the doctor’ reduced mean onset-to-groin time by 27 (car), 49 (ambulance) or 58 min (helicopter), each with a 95% CrI equal to the point estimate.
The original simulation model can be applied to different regions in the Netherlands. Strategies tested within the subregion resulted in promising results of ‘drive the doctor’ and prehospital patient routing using the RACE scale.
Parkinson’s disease (PD) is a common neurodegenerative disease, which has extensive pathology that critically includes the loss of midbrain dopaminergic neurons. This loss leads to debilitating motor features such as bradykinesia and rigidity, as well as some non-motor symptoms. Intracerebral dopamine cell transplants have been explored for many years as a new approach to treating PD and initially used human fetal ventral mesencephalic tissue with inconsistent results, related in part to major logistical challenges in sourcing enough tissue of the right quality and the limited possibilities for quality control and standardisation. Dopaminergic neurons can now be derived reliably from human stem cell sources, which may overcome some of the challenges associated with fetal tissue transplantations.
STEM-PD is a multi-centre, single-arm, dose-escalation, first-in-human advanced therapy investigational medicinal product (ATIMP) trial in Europe using a cell product that consists of dopaminergic neural progenitors derived from the RC17 human embryonic stem cell line. The aim of the study is to assess the safety, tolerability and feasibility of intraputamenal transplantation of this cell product in patients with moderately advanced PD. Eight participants will be recruited from two sites, Skånes University Hospital (Lund, Sweden) and Cambridge University Hospital (Cambridge, UK). The primary outcome of the trial is safety and tolerability, assessed by the number and nature of adverse events and serious adverse events, and the absence of space-occupying lesions on cranial MRI, in the first 12 months following transplantation. Secondary and exploratory outcomes, including clinical measures, changes in anti-Parkinson’s medication and measures of graft survival using positron emission tomography imaging, will be assessed at both 12 and 36 months post-grafting.
Ethical approval was obtained from the Swedish Ethical Review Authority (EPM dnr 2021-06945-01) and South Central - Oxford A Research Ethics Committee (reference 23/SC/0243). Clinical Trial Authorisation was given by the Swedish Medical Products Agency (Dnr: 5.1-2022-57953) and the Medicines and Healthcare products Regulatory Agency for clinical trials authorisation (reference CTA 40773/0001/001-0001). Authorisation for transfer to Clinical Trial Regulation (EU) 536/2014 was given by the Swedish Medical Products Agency (Dnr: 5.1.1-2024-100773). Potential participants will receive verbal and written information about the trial and written informed consent will be obtained prior to enrolment. A lay summary of the results of the trial will be uploaded to the trial website which is publicly accessible. Trial results will be published in peer-reviewed journals.
Parkinson’s disease (PD) is a neurodegenerative disorder characterised by heterogeneous motor symptoms, non-motor symptoms and rates of disease progression; phenotype and prognosis vary by individual. Although researchers have attempted to predict clinical outcomes using biomarkers and other variables, there are limited data on the development, validation and clinical utility of multivariable prediction models for individual prognostication in PD. In this protocol, we will develop a method for identifying, reviewing and appraising existing PD prognostic models in order to summarise the current literature, identify knowledge gaps and inform future research.
This scoping review will be guided by the methodological principles outlined in the Preferred Reporting Items for Systematic Review and Meta-Analysis extension for Scoping Reviews. We will include all multivariable models that predict disease progression in individuals with PD using traditional statistical methods or machine learning. We will exclude models that only report performance measures for one variable (ie, univariable models) or only provide effect estimates (eg, OR, HR). A detailed search of peer-reviewed research publications will be performed through 2025 using the following electronic databases: PubMed, EMBASE, Web of Science and Scopus. Article data will be extracted using Covidence. Two independent reviewers will screen articles by title and abstract for relevance, and a third reviewer will resolve any discrepancies. The remaining full-text articles will also be screened by two independent reviewers, and a third reviewer will resolve any discrepancies. Results from multivariable prediction models meeting inclusion criteria will be summarised using narrative synthesis and organised by clinical outcome. Models will also be appraised using Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis + Artificial Intelligence (TRIPOD+AI) and Prediction model Risk Of Bias ASsessment Tool (PROBAST) guidelines to identify deficiencies and areas of future study.
Ethical approval is not required for this scoping review. Findings will help clinicians make evidence-based decisions to improve prognostication in PD. Findings can also be used to inform the development and validation of additional multivariable clinical prediction models in PD. The results of this scoping review will be disseminated through peer-reviewed publications, research reports and presentations at relevant conferences.
For people whose stroke risk would be reduced by taking a long-term oral anticoagulant (OAC), it is important to implement effective strategies to support medication initiation, adherence and persistence. To do this, a better understanding of the factors associated with implementation of interventions to optimise OAC management is needed.
This scoping review aimed to summarise the evidence-based characteristics associated with implementing interventions designed to optimise long-term OAC adherence.
Primary research (published post-2000) evaluating any intervention designed to optimise implementation of long-term OAC for stroke prevention by way of change in OAC services, staff or patient behaviour.
Five databases (MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo, Cochrane Library) were searched from 1 January 2000 to 4 August 2023 using a combination of terms relating to population, intervention and study design.
Titles/abstracts were screened by at least one reviewer. Data from each full text were abstracted (with 20% double-checked for accuracy) and its implementation content reviewed, guided by the Expert Recommendations for Implementing Change strategies.
216 studies were included, with varying descriptive reporting of implementation strategies, and only 61 (28%) self-identifying as an implementation study. The median number of implementation strategies used was three, with recently published studies (2015 onwards), those including patients receiving either direct OACs (DOACs) or vitamin K antagonists (VKAs) and those including multiple intervention targets (service, staff or patients) associated with using more implementation strategies. ‘Train and educate stakeholders’ strategies were the most commonly used, and ‘Adapt and tailor to the context’ strategies were the least used by included studies. Conversely, self-defined implementation studies were less likely to use ‘Train and educate stakeholders’ strategies, although they were positively associated with use of ‘Adapt and tailor to the context’. ‘Use evaluative & iterative’ strategies were used more frequently in studies where patients used either VKAs or DOACs, or were published more recently.
Studies need to self-define as implementation studies, improve implementation strategy reporting and be transparently registered, alongside conducting process evaluations or more richly describing implementation processes. Future research could explore why some implementation strategies are used more than others and whether aligning strategy clusters with intervention targets results in clinically significant differences in patient care.