Abstract WP213: An experimental and theoretical study on electrical brain stimulation for post Intracerebral Hemorrhagic stroke rehabilitation.

Stroke, Volume 56, Issue Suppl_1, Page AWP213-AWP213, February 1, 2025. Intracerebral Hemorrhagic (ICH) stroke is the second most common type of stroke and its aftermath is often more severe than ischemia. Recent population data has shown increasing trends of ICH in middle aged people, contributing to the economic burden of society. In order to improve post ICH outcome, immediate therapeutic interventions should be administered. Hence, our research is looking into the effects of electrical stimulation of the perihematomal cortex in the hyperacute/acute phase post ICH. The end goal is to test improvement in outcomes of subjects post the administration of such a stimulation paradigm by using the observations in experimental data to validate the theoretical model and hence design a closed loop stimulation paradigm. The two approaches in the work:Experimental:Hemorrhagic stroke is induced in minipigs by injecting 2cc of blood into the ventricular space beneath sensorimotor cortex to simulate an ICH. We insert ultra flexible microelectrodes in this region to record cortical neuronal activity and administer stimulation. Neural activity (Electrophysiological) data is collected pre/post stroke and during stimulation. The data collected is analyzed to understand changes in neural activity at different points in time. Through preliminary data analysis, we could clearly see the changes in the statistics of neural activity (pre/post ICH InterSpike Interval (ISI) histogram and firing frequency histogram). Local connectivity changes were observed in the data. Further removal of stimulation artifacts and analysis of neural data before, during and after stimulation shall be performed to understand the changes that occur during stimulation.Theoretical:We have mathematically modeled a neuron-astrocyte-vascular system in the cortical perihematoma by extending Hodgkin-Huxley biophysics to simulate pre/post acute ICH and electrical stimulation paradigms in such conditions. The results obtained help us understand the changes in the system dynamics post ICH with bifurcation analysis giving unique outlook of the complex system. The simulated data shows increase in excitability of perihematomal tissue during acute phase. Further, the model also showcases calcium ion dyshomeostasis and problems in ATP production and consumption. Normal stimulation paradigms are shown to not work in such settings. Further exploration of the intricacies of the system is at focus to better understand electrical stimulation in such cerebrovascular conditions.

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Gennaio 2025

Abstract WP235: Insurance Status and Intracerebral Hemorrhage Outcomes: A Post-Hoc Analysis of the ERICH Study

Stroke, Volume 56, Issue Suppl_1, Page AWP235-AWP235, February 1, 2025. Introduction:Insurance status may serve as an indicator of social and financial barriers that impede access to quality care. Disparities in outcomes of patients with ischemic stroke have been associated with insurance coverage. However, there are few studies investigating the impact of insurance status on outcomes in patients with intracerebral hemorrhage (ICH).Methods:We performed a post-hoc analysis of the Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH) study to investigate the impact of insurance status on good functional outcome (modified Rankin Scale score of 0-3 at 90 days after ICH). A logistic regression model was adjusted for age, sex, race, mechanical ventilation, systolic blood pressure, smoking status, diabetes mellitus, atrial fibrillation, hypertension, congestive heart failure, Glasgow Coma Scale, ICH location (side and deep), ICH volume on CT, and presence of intraventricular hemorrhage. VA patients were excluded from analysis due to small sample size.Results:Among 1874 patients included in this study, 428 patients (22.8%) had Medicare, 347 patients (18.5%) had Medicaid, 183 patients (9.8%) had HMO, 568 patients (30.3%) had private insurance, and 348 patients (18.6%) were self-pay. Table 1 illustrates demographics by insurance status. The odds ratio for good outcome in those with private insurance was significantly higher in comparison to Medicare (OR 1.47, 95% CI 1.06-2.03, p=0.022, Figure 1). When comparing private insurance to all other insurance types, the odds ratio was 1.42 (95% CI 1.09-1.84, p=0.009).Conclusion:Amongst patients in the ERICH study, private insurance was associated with a higher likelihood of good outcome (mRS 0-3 at 90 days) in ICH patients compared to Medicare or other insurance status. Further study is needed to establish if this observation is causal or an epiphenomenon.

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Gennaio 2025

Abstract WP263: Successful Endovascular Thrombectomy Accelerates Recovery of Multiple Post-Stroke Domains

Stroke, Volume 56, Issue Suppl_1, Page AWP263-AWP263, February 1, 2025. Introduction:Despite evidence showing overall improvement of post-stroke outcomes following endovascular therapy (EVT), existing literature on comparative recovery rates of different stroke deficits is limited. We hypothesized that the rate of change in aphasia may vary compared to other neurological deficits in stroke patients post successful EVT.Methods:We performed a retrospective analysis of acute stroke patients at a single comprehensive stroke center who presented with aphasia and underwent EVT from 2022 to 2023 (n=122). Total and itemized NIHSS scores were documented at three separate timepoints: admission, immediately post-EVT, and at discharge; NIHSS scores were normalized by dividing each score by its maximum possible value. We also investigated the NIH Cog-4 and Motor-6 as summative scores representing domain specific cognitive and motor deficits, respectively. We analyzed the effects of TNK and successful reperfusion (TICI 2B to 3 vs 0 to 2A) on the normalized stroke deficit scores with a linear mixed-effect regression model adjusted for measurement timepoint with subjects as a random effect. We extracted each variable’s beta coefficient, representing the variable’s average effect on NIH score (e.g. average change in score from admission to post-EVT). Recovery was represented by percent changes in beta coefficient by successful vs unsuccessful reperfusion. We also evaluated the percent change in beta coefficients with a stratified analysis of ≥ TICI 2B using permutation testing (500 permutations) to test the null hypothesis that there are no change in beta coefficients between subgroups (p

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Gennaio 2025

Abstract TP53: Optimal Time Frame for Post Stroke Hospitalization Follow-Up Phone Calls

Stroke, Volume 56, Issue Suppl_1, Page ATP53-ATP53, February 1, 2025. Background:Post-discharge phone calls to stroke patients are a valuable tool to assess medication compliance, stroke education retention and prevention of emergency room visits. However, there is no optimal time frame defined by The Joint Commission for post-discharge follow-up calls. The purpose of this study was to determine if there is an optimal time frame to call patients and whether call fatigue affects call completion rate.Methods:Ischemic and hemorrhagic stroke patients discharged to home with and without home health from 2/2024 to 6/2024 were included. Participants received phone calls from a Stroke Certified Registered Nurse at 7 days (Group 1), 14 days (Group 2), and 21 days (Group 3) post-discharge. Two call attempts were made. Data collected included baseline demographics, call completion rates, stroke education and validation of knowledge retention. Call fatigue was assessed by capturing the number of times patient was contacted after discharge by health care team. Patients received a Knowledge Score of 0-6 based on recall of knowledge of diagnosis, stroke type, signs and symptoms of stroke, risk factors, medication knowledge and stroke prevention. R *** was used for data analysis.Results:178 patients were called, 64 (36%) Group 1, 61 (34%) Group 2, 53 (30%) Group 3. There were no differences in baseline demographics. 74% (131) of patients were reached successfully. There were no differences in completion among each group (49 {75%} Group 1, 42 {69%} Group 2, 40 {75%} Group 3) p=0.6 despite more calls being made by healthcare team members early on (7.09±4.55 in Group 1, 4.12±3.27 in Group 2, 3±2.89 in Group 3). There were no differences in Knowledge Score regardless of time phone call was made. Patients who were discharged home with home health had better Knowledge Score than those discharged home without home health (5.87(±0.61) vs 5.48(±1.36)) p=0.03.Conclusion:Implementing a post-discharge phone call program up to 21 days is feasible. There was no difference in call completion rates and retention of stroke knowledge despite a heavier call burden earlier on suggesting no call fatigue.

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Gennaio 2025

Abstract WP250: Post-thrombectomy subarachnoid hemorrhage: incidence, predictors, clinical relevance, and effect modulators

Stroke, Volume 56, Issue Suppl_1, Page AWP250-AWP250, February 1, 2025. Background:Subarachnoid hemorrhage (SAH) following endovascular thrombectomy (EVT) is a poorly understood phenomenon, and whether it is associated with clinical detriment is unclear.Methods:This was an explorative analysis of a national database of real-world hospitalizations in the United States. Patients who underwent EVT were included. Patients were divided into SAH and non-SAH groups, and hospitalization outcomes were compared using multivariable logistic regression models. Regression models were also used to identify significant predictors for post-EVT SAH, and significant modulators of SAH’s association with hospitalization outcomes were also assessed.Results:99,219 EVT patients were identified; 6,174 (6.2%) had SAH. Overall, SAH was independently associated with increased odds of in-hospital mortality (21.5% vs. 10.6%, adjusted OR 2.53 [95%CI 2.23-2.87], p

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Gennaio 2025

Abstract WP287: Impact of Multiple Social Determinants of Health on Blood Pressure Reduction Post Stroke: Analysis of Sex Differences

Stroke, Volume 56, Issue Suppl_1, Page AWP287-AWP287, February 1, 2025. Introduction:Effective blood pressure (BP) control post-stroke is a critical secondary prevention strategy. Research shows that social determinants of health (SDOH) may influence this process by addressing underlying factors contributing to health disparities. We conducted a secondary analysis using data from the Discharge Educational Strategies for Reduction of Vascular Events (DESERVE) study to investigate the cumulative effect of multiple SDOH domains on BP reduction in stroke survivors, with a particular focus on sex-specific outcomes.Methods:We applied the Healthy People 2020 framework to identify SDOH across the following domains: economic factors, education, social context, healthcare access, and neighborhood characteristics. Stroke survivors in the DESERVE skill-based intervention study completed a 6-month follow-up (n=361) and were classified into two groups based on the number of negative factors:

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Gennaio 2025

Multicentre adaptive randomised trial of GvHD prophylaxis following unrelated donor stem cell transplantation comparing Thymoglobulin versus calcineurin inhibitor-based or sirolimus-based post-transplant cyclophosphamide (Methods of T cell Depletion, MoTD trial)

Introduction
Graft-versus-host disease (GvHD) remains a major complication of allogeneic stem cell transplantation (allo-SCT), affecting 30–70% of patients (representing 800 new patients per year in the UK). The risk is higher in patients undergoing unrelated allo-SCT. About 1 in 10 patients die as a result of GvHD or through complications of its treatment. In patients who survive GvHD and or the complications of treatment, about 1 in 3 patients develop chronic GvHD which has a negative impact on quality of life (QoL). Many transplant protocols use alemtuzumab or anti-thymocyte globulin (ATG) in combination with a calcineurin inhibitor (CNI) and mycophenolate mofetil as GvHD prophylaxis; however, the outcomes of these treatments are complicated by high rates of infection and therefore the development of improved GvHD prophylaxis strategies represents a major unmet need.

Methods and analysis
The Methods of T-Cell Depletion trial is a prospective, multicentre, adaptive randomised trial in patients undergoing reduced intensity-conditioned unrelated donor allo-SCT. The trial will compare the novel GvHD prophylaxis regimens post-transplant cyclophosphamide (PTCy) in combination with a CNI or sirolimus (PTCy-CNI or PTCy-sirolimus, respectively) to a current standard-of-care GvHD prophylaxis involving the use of Thymoglobulin (a specific brand of ATG containing rabbit polyclonal antibodies). The primary outcome measure is GvHD-free, relapse-free survival at 1 year. Secondary outcomes include cumulative incidence of acute grade II-IV GvHD at 1 year, cumulative incidence of moderate and severe chronic GvHD at 1 year, overall survival at 1 year and cumulative incidence of non-relapse mortality at 1 year.

Ethics and dissemination
The protocol was approved by the West Midlands, Edgbaston Research Ethics Committee (20/WM/0195); initial approval was received on 11 September 2020, current protocol version (V.4.0) approval on 25 July 2023. The Medicines and Healthcare products Regulatory Authority also approved all protocol versions. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.

Trial registration number
EudraCT Number: 2019-002419-24.
ISRCTN Number: 50290131.

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Gennaio 2025

Synovial biomarkers in the diagnosis of post-traumatic osteoarthritis following anterior cruciate ligament and meniscus injuries: protocol for a systematic review

Introduction
This review aims to synthesise research evidence regarding biomarkers in the synovial fluid that may predict the risk of post-traumatic osteoarthritis (PTOA) in young adults. Considering the high prevalence of knee joint injuries, particularly among youth sports athletes, this review will focus on anterior cruciate ligament and/or meniscal ruptures. These injuries are highly associated with PTOA, with studies indicating that even with surgical reconstruction, 50%–80% of affected individuals develop knee PTOA within a 10-year follow-up.

Methods and analysis
The results of this systematic review will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Diagnostic Test Accuracy guidelines. Comprehensive electronic searches will be conducted across five platforms: four bibliographic databases (PubMed, Cochrane Central Register of Controlled Trials, Web of Science Core Collection and Embase) and ClinicalTrials.gov registry. These searches will use combinations of predefined keywords, such as “knee”, “synovial fluid”, “post-traumatic osteoarthritis”, “anterior cruciate ligament”, “meniscus”, “trauma”, “inflammation” and “biomarker”. We will include randomised clinical trials, non-randomised prospective or retrospective clinical studies, case controls, cohort studies and case series, ranging from database inception to 30 June 2024 and published in English. Two independent reviewers will screen and evaluate the retrieved studies to determine their eligibility. Any reviewer disagreements will be resolved through discussion and consensus or, if necessary, by consultation with a third reviewer. The data will be extracted from the included studies and analysed, with the risk of bias assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. A narrative synthesis will be performed to evaluate the strength and consistency of the findings, considering both the methodological quality of the included studies and the reliability of the results.

Ethics and dissemination
Ethical approval is not required for this review as it is a secondary study based on public and published data. The findings from this work will be submitted for publication in a peer-reviewed journal and presented at relevant academic conferences. Any amendments to the protocol arising from deviations during the study’s execution will be documented and reported in the final publication.

PROSPERO registration number
CRD42024534272.

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Gennaio 2025

Aspirin Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis Among Patients With Post-Thrombotic Syndrome: The Multicenter, Multinational, Randomized, Open-label ARIVA Trial

Circulation, Ahead of Print. Background: In patients with post-thrombotic syndrome (PTS), stent recanalization of iliofemoral veins or the inferior vena cava can restore venous patency and improve functional outcomes. The risk of stent thrombosis is particularly increased during the first 6 months after intervention. The ARIVA trial tested whether daily aspirin 100 mg plus rivaroxaban 20 mg is superior to rivaroxaban 20 mg alone to prevent stent thrombosis within 6 months after stent placement for PTS.Methods: In this multinational, academic, open-label, independently adjudicated trial, patients with a Villalta score >4 points, a stenosis or occlusion of the inferior vena cava, iliac veins, or common femoral vein, successfully treated with venous stent placement, were randomized in a 1:1 fashion to the study groups. Key exclusion criteria included age 75 years, contraindications to anticoagulant use or acute venous thrombosis

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Gennaio 2025

The mediating role of physical activity and quality of life in the association between knee osteoarthritis-related symptoms and physical function of post-COVID patients in Metro Manila: a study protocol

Introduction
Knee osteoarthritis (OA) is a chronic condition affecting joint function. Regular physical activity can enhance functional capacity and reduce pain. However, there is a scarcity of studies relating to knee OA during the COVID-19 pandemic, particularly its impact on symptoms and quality of life.

Methods
This analytic cross-sectional study design will recruit participants aged 40 and above from Metro Manila with knee pain and COVID-19 history. The Filipino version of the Knee Injury and Osteoarthritis Outcome Score and International Physical Activity Questionnaire-Short Form will be used to assess the mediating variables.

Analysis
The study will employ descriptive and regression analyses for data analysis and follow the Strengthening the Reporting of Observational Studies in Epidemiology statement for reporting the data.

Ethics and dissemination
This study has received ethical approval from the Ethics Review Committee of the College of Rehabilitation Sciences. Study results will be disseminated through peer-reviewed journal publications and conference presentations to ensure accessibility to healthcare professionals and stakeholders, contributing to the advancement of knee OA management in post-COVID settings.

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Gennaio 2025

Transauricular vagus nerve stimulation in preventing post-traumatic stress disorder in emergency trauma surgery patients in China: a study protocol for a multicenter, double-blind, randomised, controlled trial

Introduction
The incidence of post-traumatic stress disorder (PTSD) in emergency trauma surgery patients is 24%, emphasising the urgent need for effective early interventions and treatments. Transauricular vagus nerve stimulation (ta-VNS) modulates the autonomic nervous system by stimulating the nucleus tractus solitarius while affecting PTSD-related neural networks, including the prefrontal cortex, hippocampus and amygdala, potentially offering new options for PTSD prevention and treatment. This study aims to evaluate the efficacy and safety of ta-VNS in preventing PTSD in emergency trauma surgery patients.

Methods and analysis
This multicentre, double-blind, randomised controlled study aims to evaluate the incidence of PTSD in emergency trauma surgery patients receiving either ta-VNS or sham stimulation. A total of 350 participants will be randomly assigned to receive either active or sham stimulation. The active group will undergo electrical stimulation of the left cymba conchae at 30 Hz with a pulse width of 250 µs, using a 30 s on/30 s off cycle. The intensity will start at 0.4 V, increasing in 0.4 V increments until a tingling sensation is detected, and will be adjusted to the highest tolerable level without causing pain. The initial intervention will begin once informed consent is obtained and randomisation is completed in the preoperative preparation room, continuing until the surgery is finished. For the four postoperative days, the intervention will be administered two times per day in 2-h sessions each morning and evening. The sham stimulation group will follow a similar procedure without actual stimulation. The primary outcome is the incidence of PTSD evaluated on postoperative day 30, with secondary outcomes including recovery quality, sleep quality, and adverse events.

Ethics and dissemination
The protocol received approval from Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine, on 15 October 2024 (approval number: 20240562). The study will adhere to the Declaration of Helsinki guidelines, and written informed consent will be obtained from all participants. Results will be submitted to a peer-reviewed journal for publication.

Trial registration number
China Clinical Trial Registration Center (ChiCTR2400080342). Trial details: https://www.chictr.org.cn/showproj.html?proj=217809

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Gennaio 2025

Endoscopic sphincterotomy to prevent post-ERCP pancreatitis after self-expandable metal stent placement for distal malignant biliary obstruction (SPHINX): a multicentre, randomised controlled trial

Background
Endoscopic retrograde cholangiopancreatography (ERCP) with fully covered self-expandable metal stent (FCSEMS) placement is the preferred approach for biliary drainage in patients with suspected distal malignant biliary obstruction (MBO). However, FCSEMS placement is associated with a high risk of post-ERCP pancreatitis (PEP). Endoscopic sphincterotomy prior to FCSEMS placement may reduce PEP risk.

Objective
To compare endoscopic sphincterotomy to no sphincterotomy prior to FCSEMS placement.

Design
This multicentre, randomised, superiority trial was conducted in 17 hospitals and included patients with suspected distal MBO. Patients were randomised during ERCP to receive either endoscopic sphincterotomy (sphincterotomy group) or no sphincterotomy (control group) prior to FCSEMS placement. The primary outcome was PEP within 30 days. Secondary outcomes included procedure-related complications and 30-day mortality. An interim analysis was performed after 50% of patients (n=259) had completed follow-up.

Results
Between May 2016 and June 2023, 297 patients were included in the intention-to-treat analysis, with 156 in the sphincterotomy group and 141 in the control group. After the interim analysis, the study was terminated prematurely due to futility. PEP did not differ between groups, occurring in 26 patients (17%) in the sphincterotomy group compared with 30 patients (21%) in the control group (relative risk 0.78, 95% CI 0.49 to 1.26, p=0.37). There were no significant differences in bleeding, perforation, cholangitis, cholecystitis or 30-day mortality.

Conclusion
This trial found that endoscopic sphincterotomy was not superior to no sphincterotomy in reducing PEP in patients with distal MBO. Therefore, there was insufficient evidence to recommend routine endoscopic sphincterotomy prior to FCEMS placement.

Trial registration number
NL5130.

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Gennaio 2025