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Showing 1-20 of 47 trials
NCT05128513
Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) has been found to improve neurological function and life ability of AIS patients and approved for the treatment of AIS by China Food and Drug Administration (CFDA). A recent study imply that the neuroprotective effect of DELP involved multiple neuroprotective mechanism such as anti-inflammation, free radical scavenging, and decreasing MMP-9. Based on the multiple mechanisms, the investigator argues that DELP may exert neuroprotective effect on acute cerebral hemorrhage (ACH). In this context, the prospective, random, open-label, blind-endpoint, multi-centre study is designed.
NCT04534556
Texas Biomedical Device Center (TxBDC) has developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury termed targeted plasticity therapy (TPT). This technique uses brief pulses of vagus nerve stimulation to engage pro-plasticity neuromodulatory circuits during rehabilitation exercises. Preclinical findings demonstrate that VNS paired with rehabilitative training enhances recovery in multiple models of neurological injury, including stroke, spinal cord injury, intracerebral hemorrhage, and traumatic brain injury. Recovery is associated with neural plasticity in spared motor networks in the brain and spinal cord. Moreover, two initial studies and a recently completed Phase 3 clinical trial using a commercially available device demonstrates that paired VNS with rehabilitation is safe and improves motor recovery after stroke. The purpose of this study is to extend these findings and evaluate whether VNS delivered with the new device paired with rehabilitation represents a safe and feasible strategy to improve recovery of motor and sensory function in participants with stroke.
NCT07237048
The goal of this study is to determine if Minocycline, when added to standard care, can improve survival and functional outcomes in patients with moderate acute stroke (ischemic or hemorrhagic) aged 18 years and older. The main questions it aims to answer are: 1. Does Minocycline improve \*National Institutes of Health Stroke Scale\* (NIHSS) scores at hospital discharge and 90 days post-stroke? 2. Does Minocycline reduce stroke-related disability, all-cause in hospital mortality (mRS -\*Modified Rankin Scale\* = 6) and at 90 days besides reducing brain bleeding complications compared to standard care? Researchers will compare patients receiving oral Minocycline plus standard care to those receiving standard care only to see if Minocycline leads to better neurological outcomes and lower mortality. Participants will: 1. Be randomly assigned by block to receive either: Minocycline 200 mg orally once daily for five days within 24 hours from symptoms onset + Standard Care, or Standard Care only 2. Undergo neurological assessments using NIHSS \*National Institutes of Health Stroke Scale\* and Modified Rankin Scale (mRS) at admission, discharge, 30 days post-stroke, 90 days post-stroke 3. Be monitored for: a) hemorrhagic transformation of ischemic strokes; b) Adverse events and mortality outcomes; c) Safety and efficacy signals through interim analyses NIHSS: \*National Institutes of Health Stroke Scale\*, which is stroke severity scale, mRS: \*Modified Rankin Scale\*, which is stroke disability scale
NCT07236216
The present study will use transcranial electrical stimulation (tES) which are transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS) combined with conventional physical therapy and cognitive-motor dual task gait training in sub-acute (at least 2 weeks after stroke onset) to chronic (within 5 years post-stroke) to investigate the effect on cortical activity, spinal motoneuron excitability, cognition and motor performance. The findings may enhance the evidence to support usages of tES for improvimg cognition, motor performance as well as cortical activity and spinal motoneuron excitability in a clinical setting.
NCT04279067
There are over 7 million stroke survivors in the US alone, with approximately 795,000 new cases annually. Despite the best available physiotherapy, 30-60% of stroke survivors remain affected by difficulty walking, with foot weakness often being the main cause. Given that post-stroke gait impairments remain poorly addressed, new methods that can provide lasting improvements are necessary. Brain-computer interface (BCI) technology may be one such novel approach. BCI technology enables "direct brain control" of external devices such as assistive devices and prostheses by translating brain waves into control signals. When BCI systems are integrated with functional electrical stimulation (FES) systems, they can be used to deliver a novel physical therapy to improve movement after stroke. BCI-FES systems are hypothesized to stimulate recovery after stroke beyond that of conventional physical therapy.
NCT03820843
A stroke located in the left parieto-temporal junction is associated, in aphasic right-handed patients, with a poor prognosis for language recovery. The role of the right hemisphere in recovering post-stroke aphasia is still controversial. Our hypothesis, based on recent work in imaging, is that early activation of the right hemisphere linked to the practice of the visual arts could facilitate language recovery in extended posterior left strokes that completely disrupt language areas.
NCT07052045
Stroke, especially acute ischemic stroke (AIS) caused by a blocked blood vessel in the brain, is a leading cause of death and long-term disability. When the blockage is in a large blood vessel, a procedure called endovascular therapy (EVT)-where the clot is removed using a catheter-is highly effective. However, the sooner EVT is done, the better the outcome for the patient. Research has shown that delays between arriving at the hospital and starting EVT (called door-to-groin time) significantly reduce the chances of recovery. For example, reducing this time by just 15 minutes can mean 20 more patients (out of 1,000 treated) going home instead of to a care facility. Even a 10-minute improvement can result in over 100 extra days of independent living for patients and save more than $10,000 in healthcare costs per patient. To reduce these delays, hospitals have improved stroke workflows. In the current standard approach, patients suspected of having a stroke are taken first to a CT scan room to confirm the diagnosis, and then, if a treatable occlusion is found, to a separate room for EVT. This usually takes around 60-70 minutes. However, moving patients between rooms takes time. A new approach called "One-Stop management" could solve this. In this method, both the brain scan and the EVT procedure are done in one room-the angiography suite-using special imaging tools called flat panel CT (FDCT) and FDCT angiography (FDCT-A). A previous study with 230 patients showed that One-Stop management is possible and saves time. But there's a challenge: the decision to follow the One-Stop pathway is made before a clear diagnosis is available. That's important because not all strokes benefit from EVT. Severe stroke symptoms (measured by a score called NIHSS ≥10) can come from: * A large or medium vessel blockage (which EVT can treat), * A small vessel blockage, or * A bleed in the brain (hemorrhage). Only the first group benefits from EVT. About 85% of patients with severe symptoms fall into this category. The rest-about 15%-would not benefit, and there are concerns that FDCT might be slightly less accurate than regular CT in diagnosing these types of strokes. So, we need to test whether One-Stop management is safe and effective for all patients, not just those with treatable blockages. To do this, the GET-FAST trial will compare the One-Stop approach to the standard two-room process. Patients will be randomly assigned to one of the two strategies. Importantly, this randomization won't affect their actual treatment-everyone will still receive the best care according to current medical guidelines. The main endpoint for the evaluation of the One-Stop approach will be long-term (at 90 days) disability and dependency in daily life as measured with the modified Rankin Scale (mRS). This study will include all patients as they were assigned, regardless of what type of stroke they actually had. This is called an "intention-to-treat" analysis, and it provides the most reliable measure of the overall impact of One-Stop management. Another key aspect of the trial is that any CE-certified imaging system already used in hospitals can be used for the One-Stop process-no specific brand or model is required. This makes the results more applicable to real-world hospital settings. If GET-FAST proves that One-Stop management leads to better patient outcomes, this could transform how stroke care is delivered. More patients could return to independent living, and fewer would require long-term care -leading to major reductions in healthcare costs. For example, even a one-point improvement on a common stroke disability scale (mRS) can triple the savings in lifetime care costs.
NCT06069973
The overall goal of this project is to determine if machine learning and analysis of neurospecific biomarkers can enable early detection of upcoming or ongoing cerebral ischaemia in patients suffering from subarachnoid haemorrhage with altered consciousness due to cerebral injury or sedation. Analyses of heart rate variability, electroencephalgraphy,nearinfrared spectroscopy, cerebral autoregulation, and brain injury specific biomarkers in blood and cerebrospinal fluid will be performed.
NCT07225101
This research is studying a device already approved by the Food and Drug Administration (FDA) to treat wound closures. Researchers are studying a large group of people to continue to learn information about the safety of the STRATAFIX suture and how people's bodies react to using it over a long period of time. This research will provide additional information about using STRATAFIX sutures to close surgical wounds.
NCT07200661
Stroke patients often experience impaired balance and weight-bearing due to muscle weakness and neurological deficits. Motor rehabilitation is a crucial goal in their recovery, and transcranial direct current stimulation (tDCS) has emerged as a promising therapeutic approach. When combined with motor training, tDCS can enhance walking and balance abilities. However, there is a lack of research exploring the combination of unstable surfaces training, cognitive function, and tDCS for stroke rehabilitation
NCT06094478
Most stroke patients are initially evaluated at the closest hospital but some need to be transferred to a hospital that can provide more advanced care. The "Door-In-Door-Out" (DIDO) process at the first hospital can take time making transferred patients no longer able to get the advanced treatments. This study will help hospitals across the US "stand up" new ways to evaluate stroke patients, decide who needs to be transferred, and transfer them quickly for advanced treatment.
NCT07132996
This study investigates whether changes in spleen size over 72 hours can help predict the risk of death within 45 days in patients who were admitted to the emergency department with a type of bleeding in the brain called intracerebral hemorrhage. The spleen is a key immune organ that may shrink or enlarge in response to injury. A total of 42 adult patients with confirmed intracerebral hemorrhage were enrolled between March and September 2024 at Ankara Bilkent City Hospital in Turkey. Spleen size and brain bleeding volume were measured by imaging tests at the time of admission and repeated 72 hours later. Patients were followed for 45 days to determine survival status. The main goal of the study was to see if spleen size change (ΔSpleen) is a better predictor of death than brain bleeding volume change (ΔHematoma).
NCT05419193
Stroke-associated pneumonia (SAP) is a grave complication of stroke and one of the most important predictors for patients' poor outcomes. Stroke associated pneumoniaSAP and other infections limited the overall efficacy of stroke management. Increasing evidence suggests that sympathetic nervous system activity contributes to post post-stroke immunosuppression and emergence of infections. This study is designed to test the safety and efficacy of an adrenergic β receptor blocker propranolol in reducing SAP in hemorrhagic stroke patients, in a multi-center, randomized, open-labeled, end point-blinded, trial.
NCT06917248
The Locaste 8F Delivery Catheter by Kai MedTech has been launched in China since 2022 and has been widely used clinically. It won the government tendering in many provinces in China in early 2024. As a guiding and access device, the investigational device is used in interventional surgeries. The clinical investigation plans to conduct a non-interventional post-marketing real-world study to evaluate the safety and effectiveness of the product in clinical use. The investigator shall use the Locaste 8F Guiding Catheter according to his own surgery plan and the instruction for use (IFU) of this device. The large-bore guiding catheters (also called as long guiding sheath) by global manufacturers are generally used. Locaste 8F Guiding Catheter is marketed in China and widely accepted in clinical application. By collecting data in the real-world clinical routine treatment, the effectiveness and the safety of Locaste 8F Guiding Catheter is evaluated to provide data support of further global use of this device.
NCT06999122
The purpose of this research is to evaluate a new investigational device for the diagnosis of stroke, the EMVision emu™ Brain Scanner. Stroke is the result of a blood clot stopping the normal flow of blood in the brain (ischaemic stroke) or a breakage in a blood vessel causing bleeding in the brain (haemorrhagic stroke). Stroke is a medical emergency and must be quickly diagnosed and treated. Computed tomography (CT) or magnetic resonance imaging (MRI) scans are commonly used to diagnose stroke, but they are not always readily available. EMVision has developed the emu™ Brain Scanner, a helmet-like device which scans the head using ultra-high frequency radio signals. It is portable and easy to use, making it more accessible than CT or MRI machines. Easier access to the EMVision emu™ Brain Scanner may reduce the time taken to diagnose stroke, leading to faster treatment and better health outcomes. It is the purpose of this study in the first instance to determine the accuracy of the EMVision emu™ Brain Scanner in the detection of haemorrhagic stroke.
NCT06998082
Acute hemorrhagic cerebrovascular disease is a life-threatening condition characterized by sudden onset, rapid progression, multiple complications, poor prognosis, and high mortality. It presents a significant public health burden. During surgical interventions, precise risk stratification and effective perioperative management are crucial to mitigating intraoperative and postoperative complications, optimizing disease diagnosis, guiding severity assessment, and refining anesthesia strategies. Continuous real-time evaluation and dynamic perioperative adjustments are essential to minimize the influence of institutional variability and individual clinician-dependent decision-making. By harnessing big data-driven, evidence-based medical approaches, clinicians can enhance diagnostic accuracy and therapeutic precision, addressing a critical challenge in reducing morbidity and mortality in this patient population. This study aims to develop a comprehensive multimodal perioperative database and leverage large language models (LLMs) for the efficient extraction of structured demographic and clinical data throughout the perioperative course. By integrating real-time hemodynamic monitoring parameters, the investigators seek to elucidate the relationship between perioperative hemodynamic patterns and the incidence of postoperative complications affecting major organ systems, including the brain, heart, kidneys, and lungs. The ultimate goal is to construct a multimodal fusion early-warning model capable of real-time, simultaneous prediction of multiple perioperative complications. This AI-driven platform will function as a risk stratification and alert system for organ-specific perioperative complications in patients with acute hemorrhagic cerebrovascular disease. By providing evidence-based insights for optimized perioperative management-encompassing early warning mechanisms, diagnostic support, and individualized therapeutic strategies-the system aims to improve clinical outcomes, reduce perioperative morbidity, and lower overall mortality.
NCT05643001
The overall goal of this study is to increase health care provider awareness for common risk factors and comorbidities in patients with hemorrhagic stroke that are related to impaired brain health, to ultimately improve patients management and associated outcomes. The specific objective is to test the performance and effectiveness of a custom electronic health record (EHR)-based notification module at time of index hospitalization and at follow-up for hemorrhagic stroke survivors, before disparities in access to outpatient care may limit opportunities to intervene. The investigators hypothesize that notification of health care providers through the EHR will increase measurements of low-density lipoprotein (LDL) and glycated hemoglogbin A1c (HbA1c) and increase evaluation and management rates for obstructive sleep apnea and hearing impairment.
NCT06696131
The overall purpose of this study is to look at the safety and effectiveness of administering Tenecteplase (TNK) into the brain bleed (hematoma) instead of another clot-dissolving drug known as recombinant tissue plasminogen activator (rtPA), which is the current standard practice. Clot dissolving (Fibrinolytic) drugs work to break down blood clots and have been found to improve health outcomes when applied directly into the hematoma within the brain. Patients who take part in this study will undergo the same surgical procedure that would normally be performed to treat them, but with the exception of TNK not rtPA.
NCT04975646
Patients after stroke with upper limb spasticity treated with botulinum toxin-A (BTX-A) will be included in this two-part study. In the first part, goal attainment scaling and comprehensive assessment of motor functioning will be performed before BTX-A application and after two weeks. In the second part, the patients will be randomised into a test group performing prescribed regular exercise for two weeks and a control group exercising at their own discretion during the same period, whereby the patients' health-related quality of life will be assessed at the beginning and end of the two-week period.
NCT06365463
Telerehabilitation is an effective rehabilitation method that allows patients to receive physiotherapy remotely in their homes. The purpose of this study was to investigate the effects of home-based remote group training for balance and mobility on activities and body functions.