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Sentara is committed to improving the lives of patients with neurological disorders. The following clinical trials and research studies are under way. For more information on these clinical trials and studies, please contact our Clinical Research Coordinator at  1-877-310-8713.

Clinical Research Studies at Sentara Princess Anne Hospital:
 
Advanced Parkinson's Disease
ClinicalTrials.gov
Identifier: NCT01536015
The clinical research study will evaluate the effectiveness of an investigational drug compared to placebo (substance that has no therapeutic effect) in decreasing motor fluctuations (periods of time in which PD symptoms are evident) when used with levodopa in subjects with gastroparesis. Gastroparesis is delayed stomach emptying. The study will also observe the effects of the investigational drug on non-motor symptoms of PD such as gastroparesis, sleep, fatigue (tiredness), apathy (lack of interest), and quality of life.

Principal Investigator: Karen Thomas, DO 

Epilepsy - Cluster Seizures
ClinicalTrials.gov
Identifier: NCT01390220
An investigational intranasal medication (USL261) is being studied in outpatients with partial or generalized epilepsy as a "rescue therapy" for the treatment of seizure clusters.

Contact: Bruno Maton, MD or study coordinator at 757-388-6124

— Epilepsy with Simple or Complex Partial Onset Seizures
ClinicalTrials.gov
Identifier: NCT00866775
This is an 18-week, double-blind, randomized, historical control, multicenter study with gradual conversion to monotherapy in subjects with partial onset seizures who are not well controlled by current anti-epileptic drugs (AEDs). The 18 week double-blind treatment period consists of a 2-week titration period, 6-week taper or conversion period, and a 10 week monotherapy period.

Contact: Bruno Maton, MD or study coordinator at 757-388-6124

— ACADIA
This clinical research study will evaluate the safety and effectiveness of an
investigational medication compared to placebo (an inactive substance) in individuals
with Parkinson's Disease who are experiencing hallucinations or delusions. The
caregivers of the study participants with Parkinson's Disease and hallucinations or
delusions, also playa role in this study as their input is necessary in assessing the
health and behavioral changes of the study participant. Individuals who wish to
participate must have experienced hallucinations or delusions for at least the past
month.

Principal Investigator: Karen Thomas, DO


Medication Research Studies at Sentara Norfolk General Hospital: 

—  IRIS Insulin Resistance Intervention after Stroke Trial:
This National Institutes of Health sponsored study is examining a new therapeutic approach that is based on the detection and treatment of insulin resistance. Insulin resistance affects almost all patients with type II diabetes and 50 percent of non diabetic patients with ischemic stroke.

In epidemiologic research, it has been associated with an increased risk for coronary heart disease, stroke and several vascular risk factors including endothelial dysfunction, vascular inflammation, dyslipidemia, hypertension and abnormal fibrinolysis. Based on these associations and data from preliminary therapeutic studies, investigators have hypothesized that modification of insulin resistance may reduce the incidence of stroke and MI (myocardial infarction or heart attack).

To test this hypothesis, the IRIS trial will determine the effectiveness of a drug called pioglitazone, an agent used to reduce insulin resistance, for reducing the risk of stroke or MI (myocardial infarction or heart attack) among patients with a recent ischemic stroke or TIA (transient ischemic attack). 

—  TRA 2°P – TIMI 50 - Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic events
Patients who have blockage in one or more arteries supplying blood to the heart, brain or legs can enroll. Such blockages are most commonly due to cholesterol deposits associated with atherosclerosis.

Complications of atherosclerosis, such as heart attack and stroke, can occur when a blood clot forms rapidly in an artery causing a more severe blockage and a decrease in blood flow. Platelets are cells in the blood that form blood clots. Treatment of atherosclerosis usually includes drugs, such as aspirin, that block platelets from sticking together to form a blood clot.

We are doing a double blind, randomized trial of an investigational drug that has not been approved for use by the health authorities or the U.S. Food and Drug Administration (FDA) that blocks platelets and may reduce the risk of heart attack or stroke. The purpose of the study is to test the safety and effectiveness of the drug, when used with standard medications.

Arteriovenous Malformation Study:
The following AVM (arteriovenous malformation) study is being conducted in collaboration with neurosurgeon, Joseph L. Koen, MD, and neuroradiologist, John Agola, MD, at Sentara Norfolk General Hospital. 

—  ARUBA - A Randomized trial of Unruptured Brain Arteriovenous malformations
The purpose of this National Institutes of Health sponsored study is to determine whether it is better to treat an unruptured brain arteriovenous malformation (AVM) with one or more of several available procedures intended to eliminate the brain AVM or to rely on medical therapy to control symptoms.

An arteriovenous malformation (AVM) is a tangled bundle of abnormal arteries and veins that are directly connected to each other. In general, arteries carry fresh oxygen filled blood form the heart and distribute it through finer and finer vessels (arterioles and capillaries) to all parts of the body to nourish the tissue. Veins bring the "used" blood back form the organs, like the brain, to the heart. In an abnormality like a brain AVM, the blood goes directly from an artery into a vein since there are no fine vessels like capillaries to slow down flow. Most AVMs are present from birth, although they can form as a result of brain trauma, and some enlarge over time.

The main risk of an AVM in the brain is the risk of sudden bleeding if the brain AVM ruptures. Symptoms might resemble a stroke but may also include headaches or seizures. Some AVMs cause neurological symptoms (such as seizures and headaches) without bleeding. An AVM that has not bled is called an unruptured AVM. Sometimes a brain AVM is discovered unexpectedly as an incidental finding because of a brain scan (a CT or MRI scan) that was done for other reasons.

It is not known whether any one of the available interventional techniques, which themselves can cause bleeding in the brain, would be better than treating the symptoms (like headache and seizures) with medical therapy alone and using interventional techniques only if the AVM bleeds. The purpose of this study is to determine which is the better approach.


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