Clinical Research Directory

Cerebrovascular Health and Resilience in Midlife

This study examines cardiovascular responses to a brief psychological challenge under laboratory conditions among adult volunteers. The study volunteers are asked to complete two study sessions. In one session, the volunteers are asked to provide demographic and health-related information via questionnaires and an interview. In that session, volunteers would then be asked to undergo evaluations of their body composition, blood pressure, heart rate, and other signs of cardiovascular function and health. Lastly, volunteers would be asked to take part in a brief and challenging psychological task after a period of rest while cardiovascular activity is measured. In the other session, volunteers are asked to undergo magnetic resonance imaging and to complete neuropsychological tests of memory, attention, and processing speed. In addition to these two sessions, volunteers are asked to complete online questionnaires. The study is designed to examine associations between transient changes in cardiovascular activity induced by the psychological task, measures of overall cardiovascular health, and measures of cerebrovascular health measured by magnetic resonance imaging. Study results are expected to provide new information about the relationships between cardiovascular activity changes to psychological challenges and cardiovascular and cerebrovascular health in adults.

Identification of microRNAs Involved in Cerebral Collateral Regulation

Patients \>18 years of age presenting to Ohio State Wexner Medical Center Emergency department with stroke symptoms, within 6 hours of last know well and found to have acute anterior circulation large vessel occlusion (LVO) will be included in this study. The purpose of this study is to evaluate the differential expression of exosomal microRNAs in patients with stroke due to acute LVO as compared to healthy controls. In addition, the investigators will also evaluate the differential expression of exosomal microRNA in patients with good vs poor collateral grade.

Hybrid Stroke Rehab With Mirror Priming

This trial aims to examine the effects of enhanced mirror priming, overcoming the limitations of traditional mirror therapy, to achieve optimization and personalized intervention.

Daphnetin Capsule In the Treatment of VaScular COgnitive Impairment Without Dementia

The purpose of this clinical trial is to understand and evaluate the clinical efficacy and safety of Daphnetin Capsule in patients with vascular cognitive impairment. Changes in the Vascular Dementia Assessment Scale-cog(VADAS-cog) at 6 months were evaluated. Although Daphnetin has a dual neurovascular protective effect, however, there is still a lack of relevant high-quality studies on its role in patients with vascular cognitive impairment, especially in patients with vascular cognitive impairment in non-dementia (VCI-ND), whether it has a role in improving cognitive status needs to be urgently explored in high-quality clinical studies. Researchers are comparing Daphnetin to placebo (a drug-free analog) to see if Daphnetin is effective in treating vascular cognitive impairment. Participants will take either Daphnetin or placebo daily for six months, with follow-up visits every three months and completion of a case report form.

PRecisiOn Medicine In StrokE: Evolution of Plasma Brain-Derived Tau in Acute Stroke

The investigators recently identified Brain-derived tau (BD-tau) as a sensitive blood-based biomarker for brain injury in acute ischemic stroke: in patients with acute ischemic stroke, plasma BD-tau was associated with imaging-based metrics of brain injury upon admission, increased within the first 24 hours in correlation with infarct progression, and at 24 hours was superior to final infarct volume in predicting 90-day functional outcome. While informing on the relation of BD-tau with imaging-based metrics of brain injury, this cross-sectional study was restricted to BD-tau assessments upon admission and at day 2 and could not inform on key characteristics of the evolution of plasma BD-tau, including when exactly it starts to rise, how long it continues to rise, and how it is determined by infarct characteristics as well as comorbidities. Here, the investigators aim to assess plasma BD-tau every hour from admission to 48 hours after onset to evaluate the hypothesis that BD-tau rises immediately after onset and plateaus between three and 48 hours after onset.

MIDNOR-STROKE- a Long Term Follow-up Study of Patients With First Ever Ischemic Stroke in Central Norway

Annually 13000 Norwegians experience an ischemic stroke. The number of stroke is anticipated to increase with 50% within 2030 due to a growing number of elderly. Many of them will have severe function deficits and reduced quality of life. The investigators have established a cohort consisting of 800 patients with first time ischemic stroke treated at hospitals in Central Norway. The investigators want to study the incidence and prognostic markers for death, recurrent stroke and severe functional deficits during a period of 10 years after the initial ischemic stroke. The investigators want to focus on the impact of physical functioning, the level of physical activity and use of medication for secondary prevention on the incidence of death, recurrent stroke and severe functional deficits. The investigators are especially interested in the importance of fulfilling the treatment targets for blood pressure and cholesterol and the importance of smoking cessation in stroke survivors. Our objective is to improve todays stroke treatment and achieve a more efficient use of the health resources in order to increase survival after stroke maintaining a good physical and psychological function and quality of life.

Efficacy and Cost-Effectiveness of Cost-free Pharmacotherapy for Smoking Cessation for High-risk Smokers With Cerebrovascular Disease

Research Aims The aims of this research study are to determine whether cost-free smoking cessation pharmacotherapy: 1. Helps smokers with Transient Ischemic Attack (TIA) or stroke to quit smoking over the long-term, compared to simply providing a prescription for these medications; 2. Is a more cost-effective alternative to providing a prescription only for these medications in this high risk population. Hypotheses to be Tested The hypotheses to be tested include the following: 1. The CO-validated continuous abstinence rate at weeks 26 and 52 following a target quit date will be at least 10% higher for the cost-free smoking cessation pharmacotherapy intervention group compared to the prescription only usual care group; 2. Cost-free smoking cessation pharmacotherapy will have a greater cost-effectiveness (i.e., cost/quit) than providing a prescription only.

HYPEROXIA Responses and ROS

30 participants (15 males and 15 females) who are ≥18 - ≤ 40 years old and considered healthy will be enrolled into this study to test the role of reactive oxygen species (ROS) in regulating cerebral blood flow (CBF). Participants can expect to be on study for 2 study visits over a 6 month period.

Efficacy and Safety of Antihypertensive Treatment With Mobile Stroke Units in Ultra-Early Intracerebral Hemorrhage

MSU-ICH is a prospective, multicenter, Week-wise-randomized, open-label, blinded-endpoint (PROBE) clinical trial comparing ultra-early prehospital blood pressure lowering delivered by a Mobile Stroke Unit (MSU) with standard Emergency Medical Services (EMS) in patients with spontaneous intracerebral hemorrhage.

Visio-conference for Pre-hospital Triage of Stroke Suspicions

Interventionnal Study to investigate the accuracy of our clinical based algorithm performed by using a visioconference device to assess the eligibility of acute recanalisation treatment (intraveinous thrombolysis (IVT) and/or mechanical thrombectomie (TM). Clinical identification of type of treatment is needed is pre-hospital triage of these patients.

Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial

The study aims to evaluate the safety and efficacy of the Supernova stent retriever device, developed by Gravity Medical Technology, for treating acute ischemic stroke. The device is used to remove blood clots and restore blood flow to the brain .

Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke

Multicentre, prospective, Multi-arm Multi-stage (MAMS) seamless phase 2b/3 interventional randomized placebo-controlled double-blinded parallel-assignment (2 arms with 1:1 randomization) efficacy and safety trial to test intra-arterial tenecteplase at the completion of thrombectomy versus best practice in participants with anterior circulation LVO receiving mechanical thrombectomy within 24 hours of symptoms onset.

Video Call Assisted Assessment of Acute Stroke

This study aims to investigate whether a live stream video between the on-call neurologist and the emergency medical technicians can increase feasibility and performance of symptom-based prehospital stroke scales.

Comprehensive Management of High-risk PopuLatIon for Stroke Based on Social Network

The purpose of this study is to evaluate the effectiveness of social network in improving drug compliance and risk factors control rate of stroke high-risk population after discharge.

Home-based Cognitive Strategy Training for Daily Living in Adults With Chronic Stroke

This pilot experimental study aims to describe the feasibility of a cognitive strategy training protocol : PRPP-I, in activities of daily life across home-based setting for adults with chronic stroke for improvement of independence and quality of life. Aditionnally to examine preliminary effectiveness of PRPP-I protocol within a home-based setting on functional cognitive strategies, independence, quality of life and career burden.

Application of Device-based Training to Improve Postural Control in Older Adults With CCI

The goal of this clinical trial is to improve comprehensive rehabilitation programs for elderly patients with chronic cerebral ischemia by incorporating training methods with biofeedback for postural control training. The main objectives of the study are as follows: To evaluate the effectiveness of incorporating stabilometric training with biofeedback using the Huber system (LPG Systems, France) and treadmill-based biofeedback training using the C-Mill system (Physiomed Elektromedizin AG, Germany) into comprehensive rehabilitation programs, with respect to postural and cognitive functions in elderly patients with chronic cerebral ischemia. To conduct a comparative analysis of the effectiveness of training programs performed using the Huber (LPG Systems, France) and C-Mill (Physiomed Elektromedizin AG, Germany) biofeedback systems, based on outcomes related to gait pattern recovery, postural parameters, and cognitive performance. The investigators will compare training sessions using the Huber and C-Mill biofeedback systems with a control group (patients receiving conventional therapeutic exercise) in order to determine whether these devices are effective in improving postural control and reducing the risk of falls in patients with chronic cerebral ischemia. Participants are required to: Complete a course consisting of 8 procedures, performed once daily. Report any adverse events occurring during or after the procedures, should they arise.

Hypertension Explored in Long-term Postpartum Follow-up in Later Life

The purpose of this study is to understand more about why women who have had hypertensive pregnancies may be at increased risk of high blood pressure and why these women are often at increased risk of heart and blood vessel disease later in life.

Inhaled Nitric Oxide in Acute Ischemic Stroke Patients Undergoing Mechanical Thrombectomy

The purpose of this study is to determine the safety and feasibility of using inhaled nitric oxide (iNO) in patients undergoing intra-arterial mechanical thrombectomy (blood clot extraction or IAMT) for treatment of acute ischemic (non-bleeding) stroke (AIS).

Intra-arterial Thrombolysis for Acute Ischemic Stroke With Medium Vessel Occlusion

Acute ischemic stroke (AIS) due to medium vessel occlusion (MeVO) or severe stenosis poses a significant clinical challenge. Recent large randomized controlled trials, DISTAL and ESCAPE-MeVO, demonstrated no significant benefit of endovascular therapy in patients with MeVO. Although intra-arterial thrombolysis has shown promise in clinical experience, robust evidence supporting its efficacy in MeVO or severe stenosis-related AIS is still absent. To fill this gap, the RESCUE MeVO trial has been designed as a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study to evaluate the efficacy and safety of intra-arterial thrombolysis in patients with AIS caused by MeVO or severe stenosis.

Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage 2

Two groups of subjects will be constitute: (i) patients with circumscribed brain injury (including stroke, vascular malformations, tumor or circumscribed infectious lesions) or degenerative/developmental disorders and selective cognitive disorders; (ii) healthy control subjects. The objective of this project is to evaluate specific neuropsychological deficits and apply current brain imaging techniques (anatomical, diffusion, functional, magnetic stimulation) to patients suffering from these cognitive deficits due to brain damage, in order to elucidate the brain mechanisms underlying these deficits.

Mixed Reality and Virtual Reality Technology With Mirror Therapy for Stroke Rehabilitation

The specific study aims will be: 1. To design and develop the hardware and software of the VR+MT and MR+MT systems. 2. To test the feasibility of the VR+MT and MR+MT systems from the patients and to collect the feedback of users with respect to their experiences. 3. To examine the treatment effects of VR+MT and MR+MT compared to the traditional MT (i.e., control group) in patients with stroke by conducting a randomized controlled trial. 4. To identify who will be the possible good responders to VR+MT and MR+MT based on their baseline motor functions and mental imagery abilities.

Brain, Blood And Clot or Tissue Registry And Collaboration

This is a prospective open enrollment biorepository to collect and evaluate blood and tissue collected during cerebrovascular procedures, which will then be used for the purposes of identifying biological markers, inflammatory cell infiltrates, and biological states in stroke and other cerebrovascular diseases in the human condition. The study population will include up to 1000 subjects with cerebrovascular disease or suspected cerebrovascular disease. Male and female participants 18 years of age and older will be enrolled. This protocol covers the procurement of biological samples from patients undergoing any cerebrovascular surgery and/or neurointerventional clinical procedure at University of Kentucky. Control participants will include patients undergoing non-emergent, elective diagnostic cerebral angiography as well as patients undergoing emergent angiogram cases. This study represents the first time that tissue, clot and blood will be evaluated for the markers, proteins, and cytokines in human subjects undergoing cerebrovascular procedures. By starting with the human condition, the investigators aim to minimize this loss in translation. Overall, this study will have a great impact on our knowledge of stroke pathology. In essence, this could fundamentally change not only how the investigators develop treatment strategies for the stroke patient population but allow us to individualize the treatment dependent on time after stroke, age, sex, and co-morbidities. Molecular techniques that are impractical when delivered systemically could be delivered locally to impede the early inflammation. This research aims to advance understanding of cerebrovascular disease and to support the development of improved therapies.

Gravity Stroke System for Recanalization of Large Vessel Occlusion Strokes

Supernova and Neutron are endovascular mechanical revascularization devices indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing an acute ischemic stroke within 24 hours of symptom onset or from last known well time.

Living With Stroke - Sustainable Utilization of Healthcare Services

The proposed study will generate a national mapping of healthcare utilization patterns in people post-stroke in the chronic phase living in the community; examine the associations between individual-level characteristics, health outcomes and healthcare utilization; and will describe patients' perspectives on their needs for health services and their experiences of using them. The study will use mixed-methods methodology (quantitative and qualitative) and will proceed in three parts. In part 1, data will be extracted retrospectively from electronic medical records of of Clalit Health Services, covering all patients with a stroke diagnosis. In part 2, a sub-sample of 240 patients will be asked to answer standardized questionnaires. In part 3, a sub-sample of 20 participants will participate in in-depth, semi-structured interviews.