72 Clinical Trials for Various Conditions
Study using ultrasound of the brain as a diagnostic tool to differentiate between ischemic stroke and hemorrhagic stroke. Correlation of brain perfusion and size of stroke in relation to systemic hemodynamic targets will be assessed on serial scans.
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.
This study will evaluate the feasibility of dual tDCS to improve arm motor function in chronic stroke patients. In addition it will collect pilot data on the blood biomarkers associated with treatment effect.
A double-blinded placebo-controlled randomized trial to evaluate the effect of preventative treatment of depression in survivors of aneurysmal subarachnoid hemorrhage (aSAH), a type of stroke.
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy.
To determine the incidence and predictors of augmented renal clearance (ARC) in patients with hemorrhagic stroke.
Approximately 12% of strokes in the United States are hemorrhagic.1 Hemorrhagic stroke can lead to multiple complications including fever that is not infectious. Identifying the cause of fever can help physicians choose the best care for the patient to try and prevent further damage to the already injured brain. Bacterial infection is one possible cause of fever in the stroke patient; however an incorrect diagnosis of infection can lead to unnecessary antibiotic use. Better screening tools for infection are being developed to help fight the problem of antibiotic resistance and unnecessary antibiotic use. Unnecessary use of antibiotics in patients increases the risk of adverse events and overall healthcare costs. Procalcitonin (PCT) is one such screening tool which has been used previously to help tell apart bacterial and nonbacterial causes of infection in other disease states; however, PCT has not been studied in hemorrhagic stroke patients. The purpose of this study is to understand the progress of PCT in hemorrhagic stroke patients in order to see whether PCT can be a useful marker for infection in these patients.
The purpose of this study is to find risk factors for hemorrhagic stroke, specifically intracerebral hemorrhage (ICH). ICH, a type of bleeding into brain tissue, is a type of stroke that can result in death or disability in a large number of people. Our study hopes to identify a specific genetic risk factor that will help identify at risk individuals and target treatment strategies.
The purpose of this study is to find risk factors for hemorrhagic stroke.
The goal is to pilot test a highly accessible, web-based, pragmatic, scalable intervention to overcome ongoing problems with high stakes decision-making by surrogate decision-makers of patients in ICUs with severe acute brain injury (SABI), including those with moderate-severe traumatic brain injury, large hemispheric acute ischemic stroke and intracerebral hemorrhage.
Cerebral cavernous malformations (CCMs), one of the most common microvascular malformations in the capillary beds of the brain, are susceptible to hemorrhagic stroke. As an autosomal dominant disorder with incomplete penetrance, the majority of CCM gene mutation carriers are largely asymptomatic but when symptoms occur, the disease has typically reached the stage of focal hemorrhage with irreversible brain damage. Currently, the invasive neurosurgery removal of CCM lesions is the only treatment option, despite the recurrence of the symptoms after surgery. Therefore, there is a grave need for prognostic/monitoring biomarkers as risk predictors for stroke prevention. The objective of the proposal is to develop a set of blood prognostic/monitoring biomarkers as precise risk indicators for stroke prevention. In this project, the plan is to validate the novel serum biomarkers identified in Ccms animal models and human CCMs patients, and utilize these biomarkers with statistical algorithms for risk prediction of hemorrhagic CCMs. This proposal has been formulated based on recent findings of five serum etiological biomarkers associated with disruption of the Blood-Brain Barrier (BBB), the first step for hemorrhagic CCMs in Ccm mice models. This work will lay the groundwork for larger human trials for final validation and revolutionary potential clinical applications.
A single site, study of the SENSE device in up to 20 study subjects, (five healthy controls and five each with ICH, AIS with LVO and AIS without LVO) in whom SENSE can be applied within 24 hours of stroke symptom onset.
The overall goal of this study is to develop mesenchymal stem cell therapy for treatment of acute spontaneous hemorrhagic stroke.
This is a randomized, placebo-controlled, subject and investigator-blinded study to evaluate efficacy, safety and tolerability of BAF312 in participants with intracerebral hemorrhage (ICH)
This study aims to determine if Aquatic Treadmill Therapy is effective for improving economy of gait, gait speed, balance, and cardiovascular fitness in people with chronic stroke.
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.
The goal of this study is to explore a new intervention that supports physical activity within the first 6 weeks after stroke. All participants will complete assessments at weeks 0 and 7. During weeks 1 through 6, participants will use a Fitbit Inspire to track their step counts and meet with an occupational therapist one time per week. They will also complete weekly surveys. Physical activity levels will be measured using surveys and a wearable activPAL monitor 6 times during the study: Weeks 1, 3, 5, 7, 12, and 24.
The goal of this study is to determine if oral Minocycline's proposed neuroprotective effects further improve the clinical outcomes, including mortality, of acute stroke patients beyond the current standard stroke care in a large scale randomized prospective open label (outcome assessor blinded) clinical trial. Participants will be randomly assigned (1:1) to take Minocycline 200mg orally every 24 hours for five days, starting within 24 hours from stroke symptoms onset, in addition to standard care or standard care alone. NIHSS (The National Institutes of Health Stroke Scale) and mRS (Modified Rankin Scale) will be collected at the time of presentation, discharge and again at 30- and 90-days post-discharge. All-cause mortality will also be obtained at 30 days and 90 days.
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.
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.
A prospective cohort minimal risk study to determine the impact of the COVID-19 crisis on outcomes of neurologically injured ICU patients.
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.
Severe strokes, including large artery acute ischemic stroke and intracerebral hemorrhage, continue to be the leading cause of death and disability in adults in the U.S. Due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is the most common cause of death in severe strokes, but occurs at a highly variable rate. Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. The investigators have developed a pilot DA for goals-of-care decisions for surrogates of severe, critically ill stroke patients. This was developed through qualitative research using semi-structured interviews in surrogate decision makers of traumatic brain injury patients and physicians, and adapted to severe strokes. The investigators now propose to pilot-test a DA for surrogates of critically ill severe stroke patients in a feasibility trial.
The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized trial to evaluate safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System \[EECSS\], XIENCE Alpine EECSS and XIENCE Sierra EECSS) of coronary drug-eluting stents.
This study evaluates a program designed to help individuals transition home from inpatient rehabilitation following an ischemic or hemorrhagic stroke. Half of the participants will receive a stroke education program while the other half will receive an environmental modifications program.
The Stroke Recovery Initiative is a nation-wide participant recruitment registry that connects people who have had a stroke with researchers who are working to develop new approaches to improve recovery after stroke.
Various molecules (cytokines: interleukins, interferons and neural proteins) found in human and animal blood are reported to be elevated in acute stroke (Ischemic and hemorrhagic). Cytokines can be pro-inflammatory or anti-inflammatory. There are studies confirming level changes in serum of humans in the setting of several rheumatologic and cardiovascular diseases. As new molecular markers (cytokines and neural tissue markers) are established in scientific literature, stroke scientists are interested to evaluate the role of these in the pathophysiology of stroke. Investigators intend to study the role of these molecules in the development of stroke. Acute stroke treatment has advanced considerably in the last 10 years with the establishment of comprehensive stroke centers and approval of neuro-interventional techniques. However, the molecular advancement in stroke pathogenesis has yet to reach a milestone in the world of stroke treatment. In our opinion, creating a database of acute stroke patients containing all pertinent medical demographics and clinical information along with the laboratory data, molecular levels of pertinent cytokines/neural factors from consenting patients, will help us define and delineate the most relevant molecules that are altered in acute stroke patients and can help us further improve us understanding of the role of these in acute stroke and thereby hopefully help in the improvement of our understanding and management of stroke. Moreover, analyzing the cytokines in stroke and ICH patients would help understand their role in the acute phase, which may become potential therapeutic adjuncts for tPA and endovascular thrombectomy.
This is a single institutional registry database for the patients with stroke and cerebrovascular diseases. Stroke is the fifth leading cause of death in the United States. Despite extensive research, most of the patients die or suffer from varying degree of post-stroke disabilities due to neurologic deficits. This registry aims to understand the disease and examine the disease dynamics in the local community.
In the search for a novel marker of stroke that could be rapidly assessed in blood, the investigators developed a point-of-care (POC) lateral flow device (LFD) that rapidly (\< 15 min) detects levels of a biomarker that is released into blood following neuronal injury associated with stroke and traumatic brain injury. The protein's expression in human brain should serve as a useful biomarker of neuronal injury in stroke and traumatic brain injury.
DESERVE is a discharge education study using health workers to enroll and randomly assign 800 subjects diagnosed with TIA, or mild stroke to either risk factor education or usual care. Those patients assigned to education will receive stroke preparedness education plus risk factor reduction education, and help accessing follow up care with health workers. Those patients assigned to usual care will receive written stroke preparedness education. This protocol will evaluate the effectiveness of this intervention to reduce blood pressure, and individual stroke risk factors and future stroke risk.