Clinical Trials

The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA ...

The purpose of this study is to analyze intracranial bleeds and collections to better understand the mechanical properties and correlation with medical images. Understanding the fluid composition and mechanical behavior may allow the development of novel techniques and technology to drain hematomas and perform collections though minimally invasive approaches, thereby reducing patient discomfort and accelerating recovery.

A pivotal, prospective, multi-center, randomized, controlled, double-blinded study combining active Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with standardized task oriented rehabilitation will be conducted in patients with post-stroke motor impairment. The therapy will be provided for 6 weeks and primary outcome assessed 6 months later.

The purpose of this study is to determine the effects of continuation vs. discontinuation of statins on the risk of Intracerebral Hemorrhage (ICH) recurrence during 24 months of follow-up in patients presenting with a spontaneous lobar Intracerebral Hemorrhage (lCH) while taking a statin drug. And we will also determine the effects of continuation vs. discontinuation of statins on the occurrence of any of the following major adverse cerebro- and cardio-vascular events (MACCE) (symptomatic ischemic stroke, symptomatic myocardial infarction, newly symptomatic arterial occlusive disease (peripheral, retinal, or carotid), revascularization procedures for coronary, carotid, or peripheral arterial disease, and vascular death). 

An ancillary MRI study will be ...

A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).

The purpose of this research study is to examine how certain genes and lifetime and ongoing stress may impact rehabilitation and recovery after stroke.

The purpose of this study is to test for the long-term outcomes in function for stroke patients who get an early tracheostomy, versus those who have prolonged orotracheal intubation. 

Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation, have a particularly bad prognosis. If they require long-term ventilation, their orotracheal tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal tube below the larynx. This so called tracheostomy might be associated with advantages such as less demand of narcotics and pain killers, less lesions in mouth and ...

The purpose of this study is to determine if cytochrome P450 (CYP) enzyme family variants alter the body's metabolism of nimodipine after Aneurysmal Subarachnoid Hemorrhage (aSAH), and if actual levels of nimodipine correlate with clinical events and patient outcomes.

The overall goal of this study is to develop mesenchymal stem cell therapy for treatment of acute spontaneous hemorrhagic stroke.

The purpose of this study is to provide clinical evidence of functional improvement, safety, and economic benefit when comparing intracerebral hemorrhage (ICH) evacuation surgery to medical treatment.

.

The purpose o fthis study

A total of 8,000 patients presenting to CPSs with acute-onset AIS, ICH or aSAH and no history of dementia will be enrolled within 6 weeks of stroke onset.

All participants will undergo baseline screening for evidence of pre-stroke dementia. Those who pass baseline screening will complete a blood draw and a series of cognitive and functional assessments at baseline.

Participants will undergo in-person (3-6 months, 18 months) and telephone (annual) follow-up visits for the duration of the study to assess for longitudinal cognitive and functional outcomes. In addition to Tier 1 procedures, at each in-person follow-up visit: Tier ...

The study aims to identify predictors of brain outcomes in Hereditary Hemorrhagic Telangiectasia (HHT) patients. The study will use the modified Rankin Score (mRS). Furthermore to define a severe bleeding phenotype in HHT for clinical trial readiness. 

The specific aims of this study are to:

1. Definitively determine the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of patients with death and disability (mRS 4-6) at 3 months among subjects with ICH who are treated within 4.5 hours of symptom onset.
2. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the subjects' quality of life as measured by EuroQol at 3 months.
3. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of hematoma expansion (defined as increase from baseline hematoma volume of > ...

The purpose of this study is to examine the gait in patients with hemiplegia following a stroke, when wearing an ankle foot orthosis and without wearing an ankle foot orthosis.

The purpose of this study is to to take the usual waste material from the removal of hematoma and apply an array of -Omics approaches (including for example genomics, transcriptomics, lipidomics, proteomics, and metabolomics) to identify biomarkers that assess prognosis and identify key therapeutic targets.

C3FIT’s overall goal is to assess if patient outcomes are improved when the Comprehensive and Primary Stroke Center (CSC/PSC) system is supplemented with an Integrated Stroke Practice Unit (ISPU) system of care, a patient-centric model of care involving the patient and caregiver/family that coordinates care from the acute management through the rehabilitation and recovery of the patient.

The purpose of this study is to develop prognostic and diagnostic blood tests for symptomatic brain hemorrhage in patients diagnosed with cavernous angiomas, a critical clinical challenge in a disease affecting more than a million Americans. We further examine whether blood biomarkers can replace or enhance the accuracy of advanced imaging in association with lesional bleeding. The project tests a novel integrational approach of biomarker development in a mechanistically defined cerebrovascular disease, with a clinically relevant context of use.

The primary purpose of this study is to determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF).

The purpose of this study is to set up the infrastructure for future clinical trials for patients with cavernous malformations. To do this we will be assessing the quality of MRI and data collection from patients with cavernous malformations across multiple sites in the country. At Mayo, we will be looking at new MRI "sequences" in addition to the usual sequences to see if that helps determine which cavernous malformations may bleed again.

Study summary:

The overall plan for this study is to conduct qualitative interviews among 40 family members of patients who have been hospitalized in a coma. Subjects for this study will be recruited by local site P.I.s from intensive care units at the following 18 U.S. centers:

All interviews will be conducted virtually via video conferencing by study staff at the Yale School of Medicine and Massachusetts General Hospital. All study activities following the interviews, including data analysis and manuscript writing, will take place at the Yale School of Medicine and Massachusetts General Hospital. We expect ...

The aim of this study is to create a state-wide biorepository and resource center for cerebrovascular diseases in Florida. The Center will collect and store detailed phenotypic information, DNA, and other biofluids on affected subjects with diverse cerebrovascular conditions, including, but not limited to, ischemic stroke, transient ischemic attack (TIA), intracerebral hemorrhage (ICH), aneurysmal subarachnoid hemorrhage (aSAH), vascular dementia (VAD), anoxic brain injury, unruptured intracranial aneurysm (UIA), cavernous malformation, arteriovenous malformations (AVM), carotid and vertebral arterial dissections, symptomatic and asymptomatic cervical carotid artery atherosclerotic stenosis, non-aneurysmal perimesencephalic subarachnoid hemorrhage (naSAH), cerebral venous thrombosis (CVT), moyamoya disease, fibrosmuscular dysplasia (FMD), non-traumatic, angiography-negative subarachnoid ...