Investigator Initiated & Sponsored Work

Top

Our Institute has a long history of implementing trials that we conceived at our center, going back to the 1980s when we developed neuroprotective agents for stroke. Over time, we have focused on designing new treatment approaches for acute stroke, brain hemorrhage, and stroke recovery. In acute stroke, we have developed several approaches to amplify t-PA’s effects (argatroban, ultrasound) and these approaches have gone forward to phase III clinical trials. In brain hemorrhage, we took forward work in our laboratories that the diabetic medication pioglitazone actually promotes hematoma reabsorption in ICH and then completed a phase 2 randomized trial demonstrating the safety of high doses of pioglitazone. In stroke recovery, we are the first center to take forward a cell-based therapy from animals to stroke patients in which bone marrow is aspirated from the patient and sorted cells are then given back to the patient as an intravenous autologous auto-transfusion.

Jump to:



Acute Ischemic Stroke (AIS) Interventional Studies

mobile-stroke-unit

Mobile Stroke Unit (MSU):

PI James Grotta, MD

The Mobile Stroke Unit (MSU) is the first specialized ambulance for prehospital stroke treatment in the United States. Patients with acute ischemic or hemorrhagic stroke will participate. Since 2014, Dr. James Grotta has used the MSU to provide diagnostic tools and stroke expertise to bring acute therapeutic treatment into the community and homes. He continues this research to understand its safety, efficacy and cost effectiveness.
Data suggests prehospital care can save critical time, almost doubling the odds of reducing stroke disability; if a patient is evaluated, imaged and treated before arrival to the emergency department. The current research on this novel therapy may provide patients with a better quality of life, and potentially reducing overall healthcare costs.

masters-2-study-logo

MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2):

PI Sean Savitz, MD

MultiStem is an allogeneic, regenerative medicine advanced therapy (stem cells) indicated for treatment of acute ischemic stroke within 36 hours after symptom onset. The objectives of this study are to evaluate the efficacy and safety of MultiStem on functional outcome in participants with ischemic stroke. Further, we want to evaluate the impact of MultiStem on a patient’s quality of life and healthcare and rehabilitation services utilization; and to evaluate the mechanism of action of MultiStem through blood biomarkers, and spleen and brain imaging outcomes in subjects. This is a randomized blinded study.

select-trial-logo

Optimizing Patient’s Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT):

PI Amrou Sarraj, MD

A multicenter, observational prospective study implementing a protocol to acquire imaging and clinical variables known to affect clinical outcomes after endovascular therapy in an effort to evaluate and compare the different selection methods and criteria currently used in practice for acute ischemic stroke patients in the anterior circulation with large vessel occlusion. The study aim is to evaluate prospectively different selection methodologies for endovascular therapy, to compare them against each other to identify which method provides the highest predictive ability in the selection of patients for IAT and to devise a formula that predicts patients’ outcomes.

Sedation versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke (SEGA):

PI Roc Chen, MD and Co-I Andrew Barreto, MD

The majority of strokes are the result of blood clots in the main vessels that provide blood to the brain. When people suffer from a stroke, these blood clots produce a blockage to the normal flow of blood, which can cause brain tissue to be damaged. This often produces symptoms such as weakness or numbness to one side of the body, changes in vision, or changes in people’s abilities to speak or be understood.
Although the body may break up the blood clots on its own, doctors also use a clot-busting drug called rt-PA for patients with certain types of stroke. Unfortunately, rt-PA is not always successful in breaking up clots. Larger clots can also be removed from the brain by performing an emergency surgery called endovascular therapy which can restore normal blood flow. Endovascular therapy with stent retrievers have been shown to improve outcomes in acute stroke patients. However, there is still some controversy about the best type of anesthesia – general anesthesia (GA) vs sedation (CS) to be used during endovascular therapy.
The purpose of this study is to study whether GA during endovascular therapy results in better outcomes compared with CS during endovascular therapy among acute ischemic stroke patients.

A Phase III, blinded, randomized trial of thrombolysis in imaging-eligible, late-window patients to assess the efficacy and safety of Tenecteplase (TIMELESS):

PI Andrew Barreto, MD

This study will evaluate the efficacy and safety of a clot dissolving medication, tenecteplase, in patients with acute ischemic stroke (AIS) who arrive in the emergency department in the 4.5- to 24-hour time window. This may extend the treatment window from the current 4.5 hours restrictions to up to 24 hours after AIS.

Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of the Aureva Transcranial Ultrasound Device with Tissue Plasminogen Activator in Patients with Acute Ischemic Stroke (TRUST):

PI Andrew Barreto, MD

This is a randomized, blinded phase 3 clinical study to evaluate the efficacy and safety of transcranial ultrasound (TUS) using the Sonolysis Headframe as an adjunctive therapy to intravenous (IV) tissue plasminogen activator (tPA) therapy in participants with AIS. This novel therapy may help improve access to more advanced stroke treatment in the community hospitals, using a cost effective ultrasound device.

Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke (ZODIAC):

PI Nicole Gonzales, MD

This phase III study will utilize a multicenter, prospective randomized outcome-blinded evaluation (PROBE) approach enrolling consecutive patients with hyperacute large artery ischemic stroke to determine if use of head of bed positioning is associated with greater clinical stability. The goal of this efficacy study is to determine if head of bed positioning in hyperacute ischemic stroke prevents neurological symptom worsening. The study will achieve these goals through use of a novel protocol-enabling enrollment of consecutive large artery occlusion patients while maintaining compliance with management specified by national guidelines.

Chronic Stroke Recovery Studies

Pisces III study logo

A Randomized, Placeo-Controlled Study of the Efficacy and Safety of Intracerebral Stem Cells (CTX0E03 DP) in subjects with Disability Following an Ischemic Stroke (PISCES III):

PI Sean Savitz, MD

A randomized, multicenter study to assess the efficacy of inserting intracerebral a stem cell product, CTX0E03 DP, by measuring any change in dependency or disability. Participants must be in the stable chronic stage of stroke (6 to 12 months post stroke) with moderate or moderately severe disability as a result of an ischemic stroke. They must be between the age of 35-75 years old. Participants will be randomized to an infusion of stem cells or a placebo and will receive an intracerebral implantation, (directed into the brain on the affected side).

Acute Observational Studies

Serial Assessment of Spleen Size and Inflammatory Markers in Acute Stroke and Traumatic Brain Injury (ASSIST):

PI Alicia Zha, MD

The purpose of this prospective, pilot study is to evaluate the changes in spleen size and splenic blood flow over time using ultrasound and corresponding changes in inflammatory cytokines in the peripheral blood of acute stroke and TBI patients. We wish to ascertain whether spleen undergoes demonstrable contraction following cerebral injury, and if there is an association between degree of splenic contraction and severity of initial cerebral injury. We also aim to characterize and quantify day-to-day variation in spleen size in healthy adult and pediatric population, and explore factors that are associated with spleen size in these healthy populations. Furthermore, we will study the differences in spleen sizes between brain injury and non-brain injury hospitalized patients.

Biobank:

PI Jaroslaw (Jarek) Aronowski, MD, PhD

This biorepository focuses on obtaining tissue samples and associated data from patients with acute cerebrovascular diseases. The repository is necessary to determine biomarkers and genomic profiles in order to identify new diagnostics, treatment targets, and predictors of disease. Researchers hope to use this data to identify health trends, stroke recovery and to improve care will use the data collected.

Lesion size and Brain Atrophy changes in Patients with Hemorrhagic and Ischemic Stroke (LAPHI):

PI Muhammad Haque, MD

The purpose of this prospective, pilot study is to evaluate the changes in stroke lesion volume, loss of brain tissue (atrophy), white matter track integrity, and metabolic status of brain in stroke population over time of 2 years. For this, we would like to obtain four follow-up MRIs apart from the standard of care MRI (done at the time of admission) over the period of around 1 year to evaluate the above-mentioned changes.
This study will help in understanding the microstructural changes and the lesion resolution in the brain over the period of around 1 year. This will be useful in monitoring disease outcomes and progression and as a surrogate marker for treatment trials and hopefully impact healthcare.

Biomarkers of Acute Stroke Etiology (BASE):

PI Andrew Barreto, MD

BASE is a multisite prospective study with an estimated enrollment of up to 1100 subjects adult subjects recruited from patients who present to the Emergency Department (ED) or hospital with suspected Acute Ischemic stroke or transient ischemic attack (TIA). We want to determine if a certain blood test, ISCDX, can differentiate between strokes originated by two different pathways: a clinically diagnosed cardioembolic stroke and a large artery atherosclerotic ischemic stroke. We will also assess the ability of a different blood test, TIADX, to identify clinically diagnosed TIAs.

The Stroke, sTress, RehabilitatiON, and Genetics (STRONG) Study:

PI Susan Alderman, PhD

Stroke is the leading cause of long-term disability in Americans. Rehabilitation therapy is standard of care following stroke, as strong evidence supports that it can improve patient outcomes. However, patients show a great deal of variability in their response to post-stroke rehabilitation therapy. While a number of factors have been identified that provide insight into the basis for these inter-subject differences, overall knowledge remains limited. The team will study how stress and specific genetic factors are related to the response to rehabilitation therapy, and the maintenance of these gains over time. Variability in therapy-induced recovery after stroke is wide. This study may provide insight into biological factors underlying this phenomenon, and so may help individualize rehabilitation care.

Secondary Prevention Studies

mend study logo

MEditatioN for post stroke Depression (MEND) Study:

PI Jennifer E. Beauchamp, PhD, RN, FAAN

MEND is an early-phase feasibility and acceptability RCT investigating a dyadic breath-based meditation intervention in stroke survivors and their caregivers. The trial will amass a number of critical methodological and procedural data, which will support the design and implementation of future meditation interventions that seek to provide personalized, integrative approaches to improving health and outcomes in stroke survivors and their informal caregivers.

STOP-Stroke Study:

PI Anjail Sharrief-Ibrahim, MD, MPH

The purpose of this research study is to evaluate the effectiveness of the Stroke Telemedicine Outpatient Program (STOP) at reducing blood pressure after stroke in patients who are at risk for uncontrolled blood pressure.
There are two arms to this study. Patients will be randomized to receive usual care (standard stroke clinic visit and referral to primary care physician) after their initial stroke clinic visit or continued care in the STOP program for post-stroke risk factor and assessment management. Patients in the STOP arm receive a blood pressure monitor with blue tooth capability and a device that allows us to perform video visits in the first 6 months after hospital discharge. We can monitor blood pressure remotely and will adjust medications for better blood pressure control. The patients who participate in the program do not need to come to the clinic as all visits are conduced over telemedicine.
It is not known whether care provided by the STOP program will be of benefit compared to usual care. For this reason, some study participants will receive usual care. This will allow a careful comparison with usual care to study the effectiveness of a comprehensive approach to post-stroke blood pressure reduction via telemedicine.
Benefits: All participants will receive educational materials about the importance of blood pressure reduction after stroke. All enrolled subjects will receive 24-hour blood pressure monitoring at the end of the study.