Research & Clinical Trials
Working together with The University of Texas Health Science Center at Houston (UTHealth) Medical School, investigators at the Mischer Neuroscience Institute are shaping the future of medicine through clinical discovery and the development of new, breakthrough treatments.
In 2006, the National Institutes of Health awarded The University of Texas Health Science Center at Houston a $36 million, five-year grant to enhance clinical and translational research, and to ultimately improve patient care and community health. The UT Health Science Center, The University of Texas M.D. Anderson Cancer Center and Memorial Hermann Healthcare System partnered in planning the grant and will collaborate on many research and educational activities supported by the new Center for Clinical and Translational Sciences. Through the Clinical Innovation and Research Institute at Memorial Hermann, we will serve as the coordination point and liaison for community engagement projects with several other Memorial Hermann hospitals.
The following is a cross-section of sample research currently in progress or recently completed at the Mischer Neuroscience Institute. If you would like to learn more about participating in a research study or clinical trial, you may find our list of frequently asked questions (FAQ) helpful.
For additional information, e-mail us at research@memorialhermann.org.
The University of Texas Health Science Center at Houston (UTHealth) Medical School, in collaboration with Memorial Hermann-Texas Medical Center, is now performing clinical research trials for neuro-oncology patients.
If you would like to learn more about participating in one of our neuro-oncology research studies or clinical trials, please contact 713.704.7100.
Chart Review of Patients Who Underwent Craniotomies for Tumor Resection and Epilepsy Surgery
PRINCIPAL INVESTIGATOR: Nitin Tandon, M.D.
This retrospective review of patients who have undergone craniotomies will be used to create a database of patients who have previously undergone surgery by the principal investigator for central nervous system tumors or epilepsy.
Novo TTF-100A
PRINCIPAL INVESTIGATOR: Jay-Jiguang Zhu, M.D.
The study is a Pivotal (analogous to drug Phase III), randomized, controlled trial, designed to test the efficacy and safety of a new medical device, the NovoTTF-100A for newly diagnosed GBM patients when used in combination with temozolomide as compared to temozolomide alone.
Enrollment for this study will be 4-7 weeks following radiation and temozolomide treatment. Treatment will continue until second progression or 24 months.
Eligible participants must be >18 yrs old and screened for co-morbidities with labs. Some exclusion criteria: implanted pacemaker, defibrillator or DBS, or clinically significant arrhythmias. There are other criteria that must be present to be considered eligible for this trial.
ICT- 107 Brain Tumor Vaccine
PRINCIPAL INVESTIGATOR: Jay-Jiguang Zhu, M.D.
This is a randomized, double blind phaseIIb multicenter study of the safety and efficacy of the ICT-107vaccine in newly diagnosed patients withglioblastoma multiforme (GBM) following tumor resection. ICT-107 is an immunotherapy in which thepatient's immune response will be stimulated to kill the tumor cells.
Some ofthe patient's white blood cells (WBC) will be removed and cultured in alaboratory with purified antigens, similar to those on GBM cells. The patient'sown WBC/dendric cells (DCs) that have been exposed to the tumor antigens willthen be given back to the patient as a vaccine over several months. The goal isfor the ICT-107 vaccine to stimulate the patient's immune response to kill theremaining GBM tumor cells after surgery and chemotherapy.
Eligibleparticipants must be 18+ years old, with newly diagnosedglioblastoma multiforme (GBM). Patients must be consented afterfull tumor resection surgery and prior to starting chemoradiation therapy.Initial Screening procedures include HLA typing and apheresis to isolateperipheral blood mononuclear cells (PBMCs) to be used for the preparation ofstudy treatment (ICT--107 and Control). Patients will be randomized by age in a 2:1 ratio to ICT-107or control.
A Randomized, Double-Blind, Placebo-Controlled Ascending Single-Dose Study of the Intravenous Infusion of CNTO 0007 in Subjects Who Have Experienced Ischemic Cerebral Infarction.
PRINCIPAL INVESTIGATOR: Sean Savitz, M.D.
A safety and tolerability study of a single intravenous (IV) infusion of CNTO 0007, human stem cell product obtained from the umbilical cord of a single healthy donor, compared with placebo when administered subacutely following an ischemic stroke.
A Randomized Multicenter Clinical Trial of Unruptured Brain AVMs (ARUBA)
PRINCIPAL INVESTIGATOR: P. ROC CHEN, M.D.
ARUBA is an FDA and institutional IRB approved randomized multicenter international clinical trial designed to determine whether medical management improves long-term outcomes of patients with unruptured brain AVMs, compared to interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or in combination). This trial tests whether medical management or interventional therapy will reduce the risk of death or stroke (due to hemorrhage or infarction) by at least 46 percent (an absolute magnitude of about 9.5 percent over 5 years). A total of 400 patients will be enrolled in order to detect the hypothesized 46 percent reduction in event rate, analyzed using the intention-to-treat principal. This sample size supports a test of non-inferiority if medical management is not superior to interventional therapy. Patients are followed for a minimum of 5 years and a maximum of 10 years from randomization.
Albumin in Acute Stroke Trial – ALIAS: A Phase III Randomized Multicenter Clinical Trial of High-Dose Human Albumin Therapy for Neuroprotection in Acute Ischemic Stroke
PRINCIPAL INVESTIGATOR: Elizabeth Jones, M.D.
An efficacy study to determine whether IV high-dose albumin reduces stroke severity compared to standard care (with or without tPA) in patients within five hours of stroke onset. This study is the first to be organized and run by Emergency Physicians, and is the final pivotal step in determining if albumin is an effective stroke treatment.
Assessment of Spleen Size Reduction and Inflammatory Markers in Acute Stroke over Time (ASSIST)
PRINCIPAL INVESTIGATOR: Preeti Sahota, M.D.
An observational study to evaluate the changes in spleen size and blood flow over time using ultrasound and corresponding changes in inflammatory cytokines in acute stroke patients presenting within six hours of symptom onset. The results of the study may provide insight into potential future therapies for acute stroke targeting the immune processes in the spleen.
Blood-Brain Barrier Permeability Changes as a Predictor of Complications in tPA-treated Patients
PRINCIPAL INVESTIGATOR: Tzu-Ching Wu, M.D.
Hemorrhagic transformation and cerebral edema can be devastating complications of stroke. This retrospective study is investigating the relationship between permeability of the blood-brain barrier and stroke complications.
Bugher Foundation Center for Stroke Prevention
PRINCIPAL INVESTIGATOR: Dong H. Kim, M.D.
This project is focused on identifying gene mutations associated with cerebral aneurysm formation and understanding molecular mechanisms that lead to the disease.
Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)
PRINCIPAL INVESTIGATOR: Nicole Gonzales, M.D.
In an effort to find better ways to prevent strokes in people with carotid stenosis, this national, multi-center research study is comparing carotid endarterectomy to the study procedure, carotid artery stenting. Researchers are evaluating the relative effectiveness of both treatments in preventing stroke, myocardial infarction and death in the 30-day period immediately following the procedure.
Clinical Outcome and Patient Factors in Refusal to Intravenous Tissue Plasminogen Activator Therapy for Management of Acute Ischemic Stroke – Perspectives from a Comprehensive Stroke Treatment
PRINCIPAL INVESTIGATOR: Farhaan S. Vahidy, Ph.D.
This is a retrospective chart review study to compare the clinical outcome in patients eligible to receive tPA treatment, yet refuse it, as compared to patients who received the treatment. In addition, researchers are seeking to highlight some predictors in patient characteristics for tPA refusal.
CLOTBUST-HF Combined Lysis of Thrombus in Brain Ischemia with Transcranial Ultrasound and Systemic tPA-Hands-Free: A Phase I/II Pilot Safety Trial
PRINCIPAL INVESTIGATOR: Andrew Barreto, M.D.
The safety of a novel, external hands-free transcranial Doppler ultrasound system is being tested in two study groups: healthy subjects and people with ischemic stroke.
Combination Treatment of tPA and Apyrase for Stroke
PRINCIPAL INVESTIGATOR: Jaslow Aronowski, Ph.D.
This pre-clinical study is designed to evaluate the role of apyrase, an endogenous vascular ATPase, as mechanism to prevent thrombosis after ischemic stroke when used in combination with rt-PA.
Combination Therapy of Aspirin and Apyrase for Stroke
PRINCIPAL INVESTIGATOR: Jaslow Aronowski, Ph.D.
This pre-clinical proposal is designed to evaluate the role of apyrase, an endogenous vascular ATPase, in combination with aspirin to prevent thrombosis after ischemic stroke.
DIAS 4 – Desmoteplase in Acute Stroke
PRINCIPAL INVESTIGATOR: George Lopez, M.D., Ph.D.
An efficacy study to determine whether the potent IV clot busting drug Desmoteplase improves outcome in patients who arrive too late for IV tPA but within nine hours of stroke onset. Desmoteplase is derived from vampire bat saliva and previous studies suggest benefit in patients with normal CT scans and persisting arterial occlusion beyond three hours.
Defining Genetic and Environmental Modifiers of Vascular Disease
PRINCIPAL INVESTIGATOR: Hariyadarshi Pannu, Ph.D.
This research focuses on defining molecular differences between vascular beds, the role these differences play in conferring differential susceptibility to vascular diseases and the identification of factors that lead to variable gender-specific vascular disease susceptibility.
Ethnic/Racial Variation in Intracerebral Hemorrhage (ERICH)
PRINCIPAL INVESTIGATOR: Nicole Gonzales, M.D.
A genetic study aimed at determining the significant medical, environmental, and genetic risk factors and causes of stroke and how they may vary by race and ethnicity. Genes influencing blood pressure, blood vessel walls, clotting, and other factors may increase the risk of developing a hemorrhagic stroke. New treatments that affect these factors may be developed to prevent stroke.
Evaluation of Presidio and Cerecyte Coils in Large and Giant Aneurysms
PRINCIPAL INVESTIGATOR: P. Roc Chen, M.D.
A multi-site registry designed to assess the angiographic outcomes and morbidity/mortality of endovascular treatment of large and giant aneurysms using at least one Presidio framing coil in conjunction with other Cerecyte coils. Data is collected on immediate and 12 month post-treatment angiographic occlusion rates, morbidity and mortality rates, retreatment rates, packing density and recurrence rates. This study is principled by Micrus Endovascular Corporation, out of San Jose, California.
Genetic Analysis of Cerebral Aneurysms
PRINCIPAL INVESTIGATOR: Teresa Santiago-Sim, Ph.D.
Researchers are identifying genetic alterations that predispose individuals to cerebral aneurysms as well as potential cerebral aneurysm biomarkers that can aid in the diagnosis of individuals at an increased risk of developing the disease.
Influence of Changes in Corticospinal Tract Integrity over Time on Clinical Outcome in Acute Ischemic Stroke (ICT-AIS)
PRINCIPAL INVESTIGATOR: Sean Savitz, M.D.
This is a prospective pilot study to evaluate the influences of changes in corticospinal tract integrity over time on motor and cognitive outcomes in patients with acute ischemic stroke in the middle cerebral artery territory within 48 hours of stroke onset. Patients will undergo detailed cognitive and fine motor testing as well as advanced neuroimaging.
Intra-Arterial Treatment (IAT) in Patients with Unknown Stroke Onset Time
PRINCIPAL INVESTIGATOR: Ramy El Khoury, M.D.
Patients who wake up with stroke symptoms or patients with unknown stroke symptom onset time are typically outside the conventional three hour window for Intravenous tPA. This is a retrospective study looking at safety of IAT in presenting with unknown stroke onset times.
Is the Drip-and-Ship Approach to Delivering Intra-Arterial Therapy after IV tPA Safe for Acute Ischemic Stroke?
PRINCIPAL INVESTIGATOR: Ramy El Khoury, M.D.
Intra-arterial therapy is an investigational therapy for stroke. We are looking at safety of treating patients at outside facilities with Intravenous tPA and then transferring them for clot removal via intra-arterial procedures at our institution.
Minimally Invasive Surgery Plus tPA for Intracerebral Hemorrhage Evacuation (MISTIE)
PRINCIPAL INVESTIGATOR: George Lopez, M.D.
This study was designed to produce data regarding the capability of minimally invasive surgery (MIS) with recombinant tissue plasminogen activator (rt-PA) to remove blood clot from intra-cerebral hemorrhage patients.
MR and Recanalization of Stroke Clots Using Embolectomy (MR RESCUE)
PRINCIPAL INVESTIGATOR: James Grotta, M.D.
A comparison of intra-arterial (IA) catheter based mechanical clot removal to standard care in patients up to eight hours after stroke onset who are ineligible for or have failed treatment with IV tPA. This study is testing whether we can use an MRI in order to select patients who may benefit in this extended time window.
Neurofluctuations in Patients with Subcortical Ischemic Stroke (NISS)
PRINCIPAL INVESTIGATOR: Sean Savitz, M.D.
The purpose of this prospective observational study is to capture and report the incidence of neurological exam fluctuations and their outcome in subcortical (lacunar) stroke patients receiving standard care. The results may be used to evaluate the results of new treatments for this disorder.
Neuroimaging of Cerebrovascular Function
PRINCIPAL INVESTIGATOR: Timothy Ellmore, Ph.D.
Researchers are studying the use of high resolution structural and functional neuroimaging to measure aspects of brain anatomy and function in humans at risk for cerebrovascular disease. The team is also studying patients who have had hemorrhagic strokes in order to assess the extent of damage, impact on cognitive function, and risk for additional cerebrovascular incidents.
Phase 2/3 Study of Intravenous Thrombolysis and Hypothermia for Acute Treatment in Ischemic Stroke. The Intravascular Cooling in the Treatment of Stroke 2/3 (ICTUS 2/3) Trial
PRINCIPAL INVESTIGATOR: James Grotta, M.D.
Brain cooling has been shown to decrease brain swelling and reduce loss of neurologic function after an acute stroke. It has also been proven to be highly effective in saving lives and preventing neurological damage after cardiac arrest and after oxygen deprivation in newborns. This trial will look specifically at whether hypothermia can be used safely in elderly stroke patients.
Pleiotropic Transcription Factors as a Target for Intracerebral Hemorrhage Treatment
PRINCIPAL INVESTIGATOR: Jaroslaw Aronowski, Ph.D.
Researchers are evaluating the role of transcription factor Nrf2 in regulating cytoprotection, antioxidative defense and detoxification of brains injured by intracerebral hemorrhage.
Prospective Analysis of the Use of Thrombelastography (TEG) in Prediction of Hemorrhage in Stroke Patients
PRINCIPAL INVESTIGATOR: James Grotta, M.D.
This is an observational study to evaluate the use of thrombelastography (TEG) analysis to assess the coagulation status of patients with acute stroke presenting within three hours of symptom onset. The purpose of the study is to evaluate the efficacy of TEG as means of identifying those ischemic and hemorrhagic stroke patients at increased risk of bleeding.
Relation of Coagulability and Iodine Exposure to Outcome of Patients with Ischemic Strokes Treated with Intra-Arterial Therapy
PRINCIPAL INVESTIGATOR: Ramy El Khoury, M.D.
Coagulation disorders and excess iodine exposure could worsen patient outcome. We are studying the relation between these two factors in patients treated with Intra-arterial therapy.
Retrospective Comparison of Pediatric Stroke Patients Treated With or Without Intravenous tPA and Descriptive Analysis
PRINCIPAL INVESTIGATOR: Ramy El Khoury, M.D.
More common than previously thought, children can have strokes. We are aiming to describe our single center experience in treating pediatric patients with Intravenous tPA.
Safety/Feasibility of Autologous Mononuclear Bone Marrow Cell Treatment for Acute Ischemic Stroke
PRINCIPAL INVESTIGATOR: Sean Savitz, M.D.
Cell-based therapy has emerged as a novel investigational approach to enhance recovery after ischemic stroke. Numerous studies have shown that the administration of different types of cells are safe and improve outcome in animal models. Our researchers will enroll 30 patients who have suffered an ischemic stroke in a safety study of an IV infusion of the patient’s own cells within 24 to 72 hours after the onset of symptoms.
Safety of Autologous Bone Marrow Cell Treatment for Acute Ischemic Stroke Trial – Reasons for Poor Enrollment
PRINCIPAL INVESTIGATOR: Preeti Sahota, M.D.
This retrospective study is to assess and understand the reasons for poor patient enrollment in clinical trial, “safety of autologous bone marrow cell treatment for acute ischemic stroke” trial. The study is ongoing and in data analysis stage.
Safety of Intravenous Thrombolysis for Wake Up Stroke
PRINCIPAL INVESTIGATOR: Sean Savitz, M.D.
This is a safety study of acute treatment with IV tPA in ischemic stroke patients who wake up with their stroke symptoms. The administration of tPA must occur within three hours of awakening from sleep. The primary aim of this study is to demonstrate the safety of IV tPA in ischemic stroke patients who present to the emergency department after awakening.
Safety of Pioglitazone for Hematoma Resolution in Intracerebral Hemorrhage (SHRINC) and MRI Evaluation of Hematoma Resolution as a Surrogate Marker of Clinical Outcome in Intracerebral Hemorrhage
PRINCIPAL INVESTIGATOR: Nicole Gonzales, M.D.
This study compares the safety of pioglitazone with standard of care for patients with spontaneous cerebral hemorrhage. The drug is administered in increasing doses from 0.1 to 2 mg/kg/d for three days, followed by a lower maintenance dose, within 24 hours of the start of symptoms.
SPOTRIAS Project 2: A Pilot Study to Determine the Safety of Argatroban Injection in Combination with rtPA in Patients with Acute Ischemic Stroke
PRINCIPAL INVESTIGATOR: James Grotta, M.D.
This clinical trial is assessing the safety of combining the anticoagulant Argatroban and recombinant tPA to treat patients who have had acute ischemic stroke.
Stem Cells in Stroke Patients (STEM)
PRINCIPAL INVESTIGATOR: James Grotta, M.D.
This is a safety study of bone marrow cell harvest and IV administration of the patient’s own mononuclear stem cells in patients within 72 hours of stroke onset. This is the first human study of stem cells in stroke patients, the only one in Houston, and an approach that reduces injury and promotes recovery in animal models.
Surgical Treatment Modalities for Intracerebral Hemorrhage (ICH) Management
PRINCIPAL INVESTIGATOR: Ramy El Khoury, M.D.
Intracerebral hemorrhage represents about 15 percent of all strokes. We are comparing outcomes for two different surgical techniques: Hemicraniectomy and hemicranotomy in cerebral hemorrhage patients.
The Interventional Management of Stroke Trial – IMS III
PRINCIPAL INVESTIGATOR: James Grotta, M.D.
An efficacy study adding an intra-arterial (IA) catheter-based mechanical clot removal to IV tPA compared to standard IV tPA treatment alone in patients within three hours of stroke onset. This is the final pivotal step in determining if the combined IV + IA approach is effective in improving clinical outcome.
The Weekend Effect on Intra-arterial Therapy
PRINCIPAL INVESTIGATOR: Ramy El Khoury, M.D.
Intra-arterial therapy for acute stroke is an emergency procedure. Previous cardiac studies showed possible ‘weekend effect’ where patients treated on the weekend have worse outcomes. We are studying whether the ‘weekend effect’ exists for intra-arterial therapy in comprehensive stroke centers.
To Retrospectively Study Predictors of Outcome in Sub-Acute Ischemic Stroke in Middle Cerebral Artery (MCA) Territory During Hospitalization
PRINCIPAL INVESTIGATOR: Preeti Sahota, M.D.
The purpose of this retrospective study is to identify the predictors of outcome in patients with ischemic stroke in middle cerebral artery (MCA) territory during sub-acute stage (day two to day seven, or discharge time, whichever is earlier), irrespective of whether they undergo thrombolytic or interventional therapies during the acute stage (day one). The rationale behind this study is that the outcome during sub-acute phase is likely to have bearing on the kind of patients we select for our interventional clinical trials during this period, such as stem cell therapy.
Treatment of Central Retinal Artery Occlusion with Intra-arterial Thrombolysis
PRINCIPAL INVESTIGATOR: Ramy El Khoury, M.D.
Central retinal artery occlusion can cause complete vision loss. We are looking at outcomes of patients treated with endovascular therapy.
Utilization of Intensive Care Resources in Severe Intracranial Hemorrhage
PRINCIPAL INVESTIGATOR: Nicole Gonzales, M.D.
Researchers are identifying all patients with intracranial hemorrhage treated by the Mischer Neuroscience Institute stroke team from 2004 to January 2009. This review of medical charts is capturing information that predict whether patients should receive prolonged care or hospice care.
A Multicenter, Open-label Extension Trial to Assess the Long-Term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects with Partial-Onset Seizures
PRINCIPAL INVESTIGATOR: Jeremy Slater, M.D.
This study is demonstrating the effectiveness and safety of administering lacosamide, an investigational anticonvulsant, to patients with partial-onset seizures who are withdrawn from one to two established antiepileptic drugs.
Correlation of Waking Background Alpha Frequency with Measures of Attention and Reaction
PRINCIPAL INVESTIGATOR: Jeremy Slater, M.D.
Researchers are studying alpha brainwave frequency and its relationship to varying levels of alertness.
Diffusion Imaging for Seizure Focus Localization
PRINCIPAL INVESTIGATOR: Timothy Ellmore, Ph.D.
This project is evaluating the feasibility of using diffusion-weighted MRI (DW-MRI) to localize the seizure onset zone in epilepsy patients.
Initial Treatment of Status Epilepticus (ITSE): A Preliminary Study for FIRST: Comparison of Fosphenytoin and Levetiracetam
PRINCIPAL INVESTIGATOR: Omotola Hope, M.D.
This retrospective review of charts is being undertaken in preparation of a pilot study comparing two drugs, fosphenytoin and levetiracetam, for the control of status epilepticus unresponsive to lorazepam.
Lateralizing Memory Function in Epilepsy Patients with Oxygen-Enhanced fMRI
PRINCIPAL INVESTIGATOR: Timothy Ellmore, Ph.D.
This ongoing study is evaluating the effectiveness of oxygen-enhanced functional magnetic resonance imaging for increasing memory task-related blood oxygen level dependent signals in the hippocampus and neocortex of epilepsy patients and control subjects.
Oxygen-Enhanced Magnetic Resonance Imaging in Non-lesional Focal Epilepsy
PRINCIPAL INVESTIGATOR: Giridhar Kalamangalam, M.D., D. Phil.
This ongoing study is evaluating how effective oxygen-enhanced MRI scans are at identifying subtle brain lesions in patients with refractory focal epilepsy.
Quantitative Analysis of Electroencephalogram in Epilepsy
PRINCIPAL INVESTIGATOR: Giridhar Kalamangalam, M.D., D. Phil.
By analyzing EEG and video-EEG data already collected for clinical purposes, this study seeks new ways of understanding brain function in normal subjects and in people with neurological problems such as seizures.
SP902: A Historical-Controlled, Multicenter, Double-Blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400mg/day Monotherapy in Subjects with Partial-Onset Seizures
PRINCIPAL INVESTIGATOR: Jeremy Slater, M.D.
Lacosamide is an investigational anticonvulsant drug. This study is demonstrating the effectiveness and safety of administering lacosamide to patients with partial onset-seizures who are withdrawn from one to two established antiepileptic drugs.
A Multicenter, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients with Relapsing-Remitting Multiple Sclerosis
PRINCIPAL INVESTIGATOR: John William Lindsey, M.D.
This Phase III study is investigating whether combined treatment with the drugs interferon beta-1a intramuscular given once weekly, and glatiramer acetate subcutaneous given daily is more effective than either drug alone in treating relapsing-remitting multiple sclerosis.
Acorda Protocol MS F203: Double-Blind, Placebo-Controlled, 21-week, Parallel-Group Study to Evaluate the Safety and Efficacy of Oral Fampridine-SR (10 mg BID) in Subjects with Multiple Sclerosis and Acorda F203 Extension: An Open Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects with Multiple Sclerosis who Participated in the MS f203 Trial
PRINCIPAL INVESTIGATOR: John William Lindsey, M.D.
In this placebo-controlled study, researchers are assessing the safety and efficacy of Fampridine-SR in patients diagnosed with multiple sclerosis.
Automated MR Image Analysis in MS: Identification of a Surrogate
PRINCIPAL INVESTIGATOR: Ponnada A. Narayana, Ph.D.
Researchers are developing a general, PC-based automated image analysis system and applying it to determine those MRI metrics that best predict near-term clinical change in multiple sclerosis.
Combination Therapy in Multiple Sclerosis
PRINCIPAL INVESTIGATOR: Jerry Wolinsky, M.D.
This study is determining if the combination of interferon beta-1a and glatiramer acetate is superior to either drug as monotherapy in relapsing-remitting multiple sclerosis.
Detection of MS Related Cognitive Impairment: In search of MRI Surrogate Markers
PRINCIPAL INVESTIGATOR: Flavia Nelson, M.D.
This study is the first to use fMRI, DTI and other advanced imaging techniques to evaluate the effect of cortical lesions and white matter tract damage on cognitive function in multiple sclerosis patients.
Double-Blind, Placebo-Controlled, 20-Week, Parallel-Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects with Multiple Sclerosis and Open Label Extension Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects with Multiple Sclerosis
PRINCIPAL INVESTIGATOR: John William Lindsey, M.D.
Researchers are investigating the safety and efficacy of three dose levels of Fampridine-SR – 20 mg, 30 mg and 40 mg – in patients diagnosed with multiple sclerosis.
Epstein - Barr virus and Multiple Sclerosis: Correlation of Activity
PRINCIPAL INVESTIGATOR: John William Lindsey, M.D.
Epstein-Barr virus is a common infection linked to M.S., but it is not known if the virus actually causes the disease. This study will investigate the correlation between reactivation of Epstein-Barr virus and disease activity in multiple sclerosis. The results of this will be important in determining whether this virus may be the cause of multiple sclerosis.
Evaluation of Oral Administration of ACTH (corticotrophin) in Normal Volunteers – A Pilot Study
PRINCIPAL INVESTIGATOR: Staley Brod, M.D.
This study was designed as a prospective cohort study to determine whether oral administration of ACTH has immunological and endocrinological effects.
MRI Analysis Center for Protocol EFC6058 - A Multi-Center Double-Blind Parallel-Group Placebo-Controlled Study of the Efficacy and Safety of Teriflunomide in Patients with Relapsing Multiple Sclerosis Who are Treated with Interferon-Beta.
PRINCIPAL INVESTIGATOR: Jerry Wolinsky, M.D.
This study provides quantitative image analysis measures as supportive outcome measures.
MRI Analysis Center for Protocol EFC6260 – An International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment with 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis
PRINCIPAL INVESTIGATOR: Jerry Wolinsky, M.D.
This pivotal clinical trial provides quantitative image analysis measures as supportive outcome measures.
MRI Analysis Center for Protocol LTS6050 -- A Long-term Extension of the Multinational, Double-Blind, Placebo Controlled Study EFC6049 (HMR1726Dl3001) to Document the Safety of Two Doses of Teriflunomide (7 and 14 mg) in Patients with Multiple Sclerosis with Relapses
PRINCIPAL INVESTIGATOR: Jerry Wolinsky, M.D.
This study provides quantitative image analysis measures as supportive outcome measures.
National Multiple Sclerosis Society (NMSS): Chronic Cerebrospinal Venous Insufficiency and its relationship to MS
PRINCIPAL INVESTIGATOR: Jerry Wolinsky, M.D.
This NMSS-funded study is an ongoing interdisciplinary project to determine if punitive alterations in cerebral venous outflow can be reliably measured and if any abnormalities can be specifically associated with multiple sclerosis.
Open Label Study to Evaluate the Safety of Copaxone® and to Monitor the Neurologic Course of the Disease in Multiple Sclerosis Patients Treated with Copaxone
PRINCIPAL INVESTIGATOR: John William Lindsey, M.D.
Researchers are seeking to better understand the long-term efficacy and side effects of the drug Copaxone (glatiramer acetate) therapy in multiple sclerosis patients.
Serial Magnetic Resonance Spectroscopy in Multiple Sclerosis
PRINCIPAL INVESTIGATOR: Jerry Wolinsky, M.D.
Researchers are using serial magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) to gather data to better understand disease processes in patients with multiple sclerosis.
Identification of New Markers and Therapeutic Targets in Glioblastoma Multiforme (GBM)
PRINCIPAL INVESTIGATOR: Min Li, Ph.D.
This study is to identify new markers for diagnosis and novel therapeutic targets for molecular-targeted therapy in GBM using genetic and molecular approaches.
Deep Venous Thrombosis in Post-Stroke Hemiplegia: Associated Risk Factors Placing Patients at Risk
PRINCIPAL INVESTIGATOR: Nneka Ifejika-Jones, M.D.
Researchers are gathering preliminary data on acute stroke patients who have developed a deep venous thrombosis (DVT) during hospitalization for inpatient neurorehabilitation, despite having received preventive medication.
Functional Brain Reorganization in Stroke Recovery
PRINCIPAL INVESTIGATOR: Andrew Papanicolaou, M.D.
Investigators are using MEG to assess how the brain reorganizes itself during spontaneous recovery from stroke. They are also studying the effects of constraint induced therapy in the recovery process of language, sensory and movement functions.
Improving Ambulation Post Stroke with Robotic Training
PRINICPAL INVESTIGATOR: Elizabeth Noser, M.D.
The goal of this research is to look at a new rehabilitation technique for people who have suffered a stroke causing difficulty walking. The present study is a research study designed to compare robotic-assisted rehabilitation therapy using the Lokomat with standard physician therapy to improve walking after stroke.
Baxter-PNS 2010-2011 Fellowship Award
PRINCIPAL INVESTIGATOR: Kazim Sheikh, M.D.
The purpose of this project is to evaluate whether neuron specific inhibition of RhoA leaded to enhanced regeneration and repair in injured nerves.
Biologic Effects of Anti-Ganglioside Antibodies
PRINCIPAL INVESTIGATOR: Kazim Sheikh, M.D.
Examine the biologic effects of anti-ganglioside antibodies on nerve regeneration.
GBS/CIDP Foundation Grant
PRINCIPAL INVESTIGATOR: Kazim Sheikh, M.D.
Researchers are engineering chimeric proteins to enhance nerve repair in antibody-mediated preclinical models of autoimmune neuropathy.
Neuroprotection and enhancement of Nerve Repair with Erythropoietin (EPO) in Experimental Allergic Neuritis (EAN)
PRINCIPAL INVESTIGATOR: Kazim Sheikh, M.D.
The purpose of this study is to examine the neuroprotective properties of EPO in EAN. Non-Invasive Imaging to
Quantify Peripheral Nerve Injury and Repair in Clinic
PRINCIPAL INVESTIGATOR: Kazim Sheikh, M.D.
Researchers are studying diffusion tensor imaging to assess and quantify nerve degeneration and regeneration in patients with traumatic nerve injuries.
Pathogenesis of Anti-Ganglioside Anti-Mediated Neuropathies
PRINCIPAL INVESTIGATOR: Kazim Sheikh, M.D.
Researchers are evaluating the role of pathogenic mechanisms of anti-ganglioside antibodies in autoimmune neuropathy.
Phenotype Differences in Motor and Sensory Neuron Regeneration in Inbred Mice
PRINCIPAL INVESTIGATOR: Kazim Sheikh, M.D.
This study is determining the genetic drivers of phenotypic differences in nerve regeneration in inbred mice.
A Natural History of Rapid Eye Movement (REM) Sleep Behavior Disorder as Prognostic for Parkinson’s disease
PRINCIPAL INVESTIGATOR: Mya Schiess, M.D.
Researchers are validating a combination of biological and clinical markers in people with REM to sleep behavior disorder as an indicator of the state of idiopathic Parkinson’s disease before symptoms appear.
Amyloid-beta Oligomers and Alzheimer’s Diagnosis
PRINCIPAL INVESTIGATOR: Claudio Soto, Ph.D.
The major goal of this project is to adapt the protein misfolding cyclic amplification (PMCA) technology for the specific and high sensitive detection of misfolded Aβ oligomers in human biological fluids. Investigators are optimizing the experimental conditions of cyclic amplification of Aβ misfolding, identifying Aβ misfolded oligomers in AD biological fluids, and evaluating the sensitivity and specificity and the earliest time during the pre-symptomatic phase in which Aβ oligomers can be detected in biological fluids.
Cross-sectional Cohort Study of Laboratory and Clinical Patterns in Early Parkinson’s disease
PRINCIPAL INVESTIGATOR: Mya Schiess, M.D.
This study is designed to characterize and define serum and cerebrospinal fluid valued for inflammatory cytokines and early idiopathic Parkinson’s disease (IPD). Researchers are also looking for patterns in early IPD, hoping that they may lead to early diagnosis before symptoms occur.
Cyclic Amplification of Prion Protein Misfolding
PRINCIPAL INVESTIGATOR: Claudio Soto, Ph.D.
The major goals of this project are to understand the mechanism of prion replication and the nature of the infectious agent, and to develop novel strategies for diagnosis of prion diseases.
Neurodegeneration in Prion Diseases
PRINCIPAL INVESTIGATOR: Claudio Soto, Ph.D.
This study is investigating the mechanism of brain degeneration in prion diseases and in particular, the role
of the endoplasmic reticulum chaperones protein Grp58.
Pathogenesis, Transmission and Detection of Zoonotic Prion Diseases
PRINCIPAL INVESTIGATOR: Claudio Soto, Ph.D.
Researchers are studying the pathogenesis and routes of propagation of bovine spongiform encephalopathy and chronic wasting disease, and developing novel strategies for the detection of infected animal.
Pathogenic Mechanism of Prion Disease
PRINCIPAL INVESTIGATOR: Claudio Soto, Ph.D.
This Program Project grant involves several groups. Our major goal is to understand the molecular basis of human prion replication and to develop novel strategies for diagnosis.
Peripheral and Central Protein Biomarkers of Brain MR Activity in Demyelinating Disease
PRINCIPAL INVESTIGATOR: Staley Brod, M.D.
By studying patients with new or disappearing brain lesions, it may be possible to identify protein markers that repair damage to the brain and can be used as future therapies. This sub-study is investigating whether specific proteins in the blood and spinal fluid change in the presence of new brain lesions.
Small-Molecule Beta-sheet Breaker Peptidemimetics for Alzheimer’s Therapy
PRINCIPAL INVESTIGATOR: Claudio Soto, Ph.D.
This project seeks to identify small chemical molecules mimicking the structure and activity of β-sheet breaker peptides previously demonstrated to be active in inhibiting and disassembling amyloid fibrils.
Biomarkers for Pain in Spinal Cord Injury
PRINCIPAL INVESTIGATOR: Gigi Hergenroeder, R.N.
Investigators in this clinical trial believe that spinal cord injury (SCI) patients who develop chronic pain have biomarkers in their blood that can predict their condition. Acute patients, and patients two or more years post injury, who have been identified as having neuropathic pain or no pain, will be asked to donate blood samples that will be evaluated for biomarkers. The ultimate goal of the research is early intervention to prevent the onset of chronic pain.
Combinatory Strategies to Functional Remyelination after Spinal Cord Injury
PRINCIPAL INVESTIGATOR: Qilin Cao, Ph.D.
Researchers are identifying optimal strategies to genetically modify oligodendrocyte precursor cells prior to transportation to promote remyelination and functional recovery after spinal cord injury.
North American Clinical Trials Network for the Treatment of Spinal Cord Injury: Spinal Cord Injury Registry
PRINCIPAL INVESTIGATOR: Michele Johnson, M.D.
Researchers hope to bring promising therapies for spinal cord injury (SCI) patients from the laboratory to clinical trials in a manner that will provide evidence of effectiveness, with maximum safety, to patients undergoing treatment. This is an observational study charting the natural course of SCI
Norepinephrine and TBI-Associated Prefrontal Dysfunction
PRINCIPAL INVESTIGATOR: Nobuhide Kobori, M.D.
The overall goal of the project is to identify the biochemical and cellular mechanisms underlying cognitive function deficits due to traumatic brain injury. The NIH grant is particularly focused on the investigation of the dysregulated neurotransmitter signaling (norepinephrine and serotonin) in the prefrontal cortex.
Novel Neuroprotection Therapeutic Approaches for Spinal Cord Injury (SCI)
PRINCIPAL INVESTIGATOR: Qilin Cao, Ph.D.
The goal of this grant is to study the molecular mechanism to regulate the blood-brain barrier of normal adult central nervous system after SCI, and to identify new therapeutic targets for SCI and other neurological diseases by protecting the bloodbrain.
Novel Restorative Therapy for Spinal Injury
PRINCIPAL INVESTIGATOR: Qilin Cao, Ph.D.
This study is examining the therapeutic potential of ApoE peptides for spinal cord injury.
Project 2-Effects of Erythropoietin on Anemia and Need for Transfusion (a component of the Program Project “Vascular Mechanisms of Secondary Injury after Traumatic Brain Injury (TBI)”)
PRINCIPAL INVESTIGATOR: Imoigele Aisiku, M.D.
This study examines the effects of TBI on cerebral blood flow (CBF) and the effect of erythropoietin in CBF.
Safety and Pharmacokinetics of Riluzole in Patients with Traumatic Acute Spinal Cord Injury
PRINCIPAL INVESTIGATOR: Michele Johnson, M.D.
The purpose of this study is to develop acute care safety and pharmacokinetic profiles of riluzole in patients who have sustained a traumatic spinal cord injury. Researchers are also conducting exploratory analyses of functional outcomes for purposes of planning a subsequent Phase II b – Phase III randomized study of the efficiency of Riluzole for the treatment of acute spinal cord injury.
Targets and Functional Consequences of Altered MicroRNAs in Models of Acute and Chronic SCI
PRINCIPAL INVESTIGATOR: Meredith L. Moore, Ph.D.
We have identified more than 75 microRNAs with altered expression in the chronically injured spinal cord with the potential to contribute to continued inflammatory responses, pain, and the inhibition of recovery. We have also identified differential expression of microRNA between patients with and without neuropathic pain. Current studies are underway to determine if this microRNA could be used in acutely injured patients as a predictor of neuropathic pain development.
A Cross-model Synthetic Approach to Eloquent Cortical Regions
PRINCIPAL INVESTIGATOR: Nitin Tandon, M.D.
The purpose of this study is to understand the mechanisms of language production through an integrated application of functional MRI, diffusion tensor imaging tractography and intra-cranial electrophysiology.
Brain Mapping with MEG
PRINCIPAL INVESTIGATOR: Andrew Papanicolaou, M.D.
This study is using noninvasive MEG imaging to compare the structure and function of the nervous system of subjects who have developed normally and people with learning disabilities or neurological diseases such as epilepsy, stroke, autism, and other disorders.
Chart Review of Patients Who Underwent Craniotomies for Tumor Resection and Epilepsy Surgery
PRINCIPAL INVESTIGATOR: Nitin Tandon, M.D.
This retrospective review of patients who have undergone craniotomies will be used to create a database of patients who have previously undergone surgery by the principal investigator for central nervous system tumors or epilepsy.
Clinical Interventions to Increase Organ Procurement, Nutritional Status and Enteral Absorption Capability after Brain Death
PRINCIPAL INVESTIGATOR: Gigi Hergenroeder, R.N.
This study is gathering preliminary data evaluating the effect on donor organ outcome of enteral feeding with immunomodulating nutrition containing omega-3 and omega-6 fatty acids, antioxidants and glutamine.
Comparative Analysis of Structural and Functional Characteristics of Language Regions as Measured by Functional Imaging and Invasive Electrophysiology
PRINCIPAL INVESTIGATOR: Nitin Tandon, M.D.
Researchers are working to accurately locate regions of the brain involved in the making of language. Functional MRI (fMRI) will be used to detect activity in various regions of the brain during tasks performed by patients with brain tumors or epilepsy, as well as normal subjects. The second part of the study is focused on patients being evaluated for epilepsy surgery. As part of the evaluation, they will undergo electrical brain stimulation using the same safety guidelines as used in standard medical care, to closely study the areas of the brain involved in language, movement and vision.
Fronto-Basal-Ganglia Circuits for Selective Stopping and Braking
PRINCIPAL INVESTIGATOR: Nitin Tandon, M.D.
This project uses intra-cranial brain recordings and fMRI to understand the dynamics of the brain substrates involved in cognitive control.
Nano-Engineered, Multi-Channel Scaffolds for Axon Regeneration
PRINCIPAL INVESTIGATOR: Qilin Cao, Ph.D.
Researchers are identifying the optimal nano-scaffolds for axonal growth in vitro.
Neuroprotection Against Hypoxic/Ischemic Injury and Other Neurological Disorders
PRINCIPAL INVESTIGATOR: Ying Xia, M.D.
This NIH funded study is investigating brain protection against ischemia, hypoxic dysfunction and epileptic hyper-excitability, and exploring effects of acupuncture on neurological disorders.
Neuroscience Research Repository (NRR)
PRINCIPAL INVESTIGATOR: Dong H. Kim, M.D.
The NRR is a prospective database and tissue sample bank that will improve knowledge of neurological illness and injury, and ultimately change the way patient care is delivered. The NRR collects samples from consenting patients for clinical, genomic and proteomic analysis. Researchers began enrolling patients in the NRR at Memorial Hermann-TMC in the spring of 2009.
The Neural Substrates of Common and Proper Naming
PRINCIPAL INVESTIGATOR: Nitin Tandon, M.D.
This project uses intra-cranial brain recordings to understand the location and interaction between the substrates involved in fluent generation of nouns and verbs, and in their failure to do so, called the “tip-of-tongue” phenomena.