Research Projects

Clinical research is an important component of the mission of the Neuroscience Institute. Staff members are actively involved in a number of basic science, clinical, and translational research studies which will help to improve how neuroscience patients are cared for.

Clinical Trials Currently Enrolling Patients

CREST-2

Principle Investigator: Robert Ecker, M.D.

CREST-2 is designed to compare three different methods of stroke prevention, to find the safest and most effective treatment for people who have narrowing of their carotid artery with no symptoms. The stroke prevention methods include intensive medical management alone compared to intensive medical management in combination with a procedure to reopen the carotid artery in the neck (revascularization) for treatment of plaque buildup. The two procedures available in this trial are carotid endarterectomy and carotid stenting. All study participants will receive intensive medical management to help control their risk factors for stroke. Please contact Debbie Cushing, RN at 207-885-4438 or cushid@mmc.org.

DRIPS (Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery)

Principal Investigator: Anand Rughani, M.D.

DRIPS is a prospective, double-blind, randomized, placebo-controlled trial to assess the efficacy of tamsulosin to prevent postoperative urinary retention in males over 50 years of age undergoing elective spine surgery at Maine Medical Center. Please contact Debbie Cushing, RN at 207-885-4438 or cushid@mmc.org.

Effectiveness and Safety of Small Aneurysm Coiling Trial (NANO trial)

Principal Investigator: Matthew Sanborn, M.D.

This is a prospective cohort study in which patients who undergo endovascular treatment with coils for very small intracranial aneurysms (less than 4 mm) will be studied during the procedure and for 12-18 months post-treatment. Please contact Debbie Cushing, RN at 207-885-4438 or cushid@mmc.org.

SETPOINT 2 (Stroke-Related Early Tracheostomy vs. Prolonged Orotracheal Intubation in Neurocritical Care Trial 2)

Investigators: Dave Seder, M.D.; Richard Riker, M.D.

SETPOINT 2 is a randomized Phase III clinical trial of very early tracheostomy (before day 5) vs. standard ventilator weaning (tracheostomy after day 10, if necessary) for patients with severe ischemic and hemorrhagic strokes, designed and powered to show a difference in functional outcomes. Please contact Barbara McCrum, RN or David Seder M.D. if you'd like to learn more.

CHARM

Investigators: Paul Muscat, MD.; David Seder, MD., Richard Riker, MD., Teresa May, DO, Jane Morris, MD, Diana Goodman, MD, Patricia Lerwick, MD, Patrick Mailloux, DO, Angela Leclerc PA-C, Pauline Boyce PA-C, Andrew Busler ACNP.

CHARM is a Phase 3 randomized study to assess efficacy and safety of intravenous (IV) BIIB093 (Glyburide) in patients with a severe ischemic stroke who are likely to develop malignant edema (swelling of the brain). The trial is sponsored by Biogen. Please contact Ashley Eldridge or Christine Lord if you'd like to learn more.

HASH4-CSF

Investigators: ELIZABETH K. GLISIC, PHARM D; DAVID B. SEDER, MD; SERGEY RYZHOV, PHD; TERESA MAY, DO; RICHARD RIKER, MD; LEE LUCAS, PHD; VALERIE CARPENTER, PA-C; IVETTE F. EMERY, PHD.

Persistent headache is a significant medical issue that affects 20% of patients who survive an aneurysmal subarachnoid hemorrhage (SAH) which is a type of stroke. Previous studies suggest that the persistent headache may be a result of inflammation in some areas of the brain. The goal of this study is to measure key elements in the blood and spinal fluid in order to determine the severity of this inflammation in the hope to learn new ways to treat these patients in the future. Please contact Ashley Eldridge or Christine Lord if you'd like to learn more.

PCAS

Investigators: David Seder, MD; Richard Riker, MD; Teresa May, DO; Ilka Pinz, PhD Sergey Ryzhov, MD, PhD; Calvin Vary, PhD

Outcomes after cardiac arrest (when your heart stops beating) is still generally poor, despite steady improvements in the care of these patients. For patients that survive the cardiac arrest they are at risk of not surviving to hospital discharge often due to a systemic inflammatory response (the post-cardiac arrest syndrome or PCAS) that can lead to brain damage from lack of oxygen. The goal of this study is to look at elements in the blood that affect this inflammatory response with the hope to learn new ways to treat these patients in the future.Please contact Ashley Eldridge or Christine Lord if you'd like to learn more.

ACCESS TRIAL

Investigators: David Seder, MD; Samip Vasaiwala, MD.; Richard Riker, MD; Teresa May, DO.

ACCESS is an NHLBI funded multi-center research study that aims to determine the best method of care for survival and neurological recovery for patients resuscitated after cardiac arrest due to ventricular fibrillation (VF) outside of the hospital, but who have no evidence of a heart attack on electrocardiogram (ECG). Maine Medical is partnering with the University of Minnesota for this clinical trial. Please contact Ashley Eldridge or Christine Lord if you'd like to learn more.

BOOST3 Trial

Investigators: Teresa May, DO; Jeffrey Florman, MD; Bruce Chung, MD

BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU). The study will determine the safety and efficacy of a strategy guided by treatment goals based on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) as compared to a strategy guided by treatment goals based on ICP monitoring alone. Both of these alternative strategies are used in standard care. It is unknown if one is more effective than the other. In both strategies the monitoring and goals help doctors adjust treatments including the kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. The results of this study will help doctors discover if one of these methods is more safe and effective. Please contact Ashley Eldridge or Christine Lord if you'd like to learn more.

Additional Studies (non-clinical trials)

Floor After Four: Non-ICU Post-Craniotomy Care

Principal Investigator: Jeffrey Florman, M.D.

Classic neurosurgical teaching and practice recommend that intensive care is necessary for management of patients after brain surgery, but this is being challenged worldwide. We have initiated a practice in which a select group of patients undergoing elective supratentorial craniotomy for tumor are sent directly to the floor instead of the ICU, after at least four hours of observation in the post-anesthesia recovery unit. This study is looking back at these patients, from 2011 to the present, to review our experience and evaluate the safety of this practice. Please contact Debbie Cushing R.N. if you’d like to learn more.

Use of Prophylactic Anti-Convulsant Therapy in Patients Undergoing Elective Craniotomy for Tumor

Principal Investigator: Anand Rughani, M.D.

There is a wide variation among providers in the utilization of prophylactic anticonvulsant therapy in patients undergoing elective craniotomy for tumor. Most surgeons here at MMC do prescribe these medications before brain tumor surgery, but the most recent recommendations do not endorse this practice. This retrospective review of all brain tumor patients presenting since 2011 will better define our practice patterns and allow us to make recommendations on how to align our use of prophylactic anticonvulsants with current standards. Debbie Cushing R.N. if you’d like to learn more.