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 neurosciences patients are cared for.
Clinical trials that are currently enrolling patients:
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. Contact Debbie Cushing at (207) 885-4438 if you think you may be a candidate for this study.
Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery
Principal Investigator: Alexa Craig, M.D.
Babies with congenital heart defects often require surgical procedures to repair the heart. This may involve placing the infant on a cardiopulmonary bypass machine. It is common practice to cool the infant’s body to help protect the brain during that part of surgery, and to rapidly rewarm them in less than an hour once surgery is complete. This research project is studying the effects of the speed of rewarming, by increasing the rewarming period up to 12 hours (“delayed rewarming”). Please contact Debbie Cushing R.N. if you’d like to learn more.
Longitudinal Assessment of Neurocognitive Function in Glioma Patients
Principal Investigator: Christine Lu-Emerson, M.D.
Many brain tumor patients experience mental decline, and this loss of mental function is not well understood. This study is examining the mental function of patients undergoing treatment for a type of brain tumor called glioma. Patients will be tested for memory, attention, learning and manual dexterity before their radiation and/or chemotherapy, and at several time points after treatment has finished. Please contact Debbie Cushing R.N. if you’d like to learn more.
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 R.N. if you’d like to learn more.
Investigators: Dave Seder, M.D.; Samip Vasaiwala, M.D.; Richard Riker, M.D.
This is a randomized study to evaluate the safety/efficacy of performing early coronary angiography in post-cardiac arrest patients without ST segment elevation on their post-resuscitation ECG versus no early cath (> 6 hours.) Only patients in whom a cardiac etiology for their arrest is suspected will be enrolled (i.e. patients with PE, asphyxiation, etc. will not be included.) Please contact Barbara McCrum R.N. or David Seder M.D. if you'd like to learn more.
Investigators: Dave Seder, M.D.; Heidi Henninger, M.D.; Paul Muscat, M.D.; Eric Gunnoe, M.D.; Richard Riker, M.D.
A research trial to evaluate the efficacy and safety of SAGE-547 (Allopregnanolone) in patients in Super Refractory Status Epilepticus. These patients (both pediatric and adult) have: failed to respond to at least one first line agent (e.g. IV benzodiazepine) and failed to respond to at least one second-line agent (e.g. phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam, etc.) with a plan to start third –line agents. SAGE-547 (allopregnanolone) is an endogenous, naturally occurring neuroactive steroid, and a metabolite of progesterone. Initial study of this drug has showed promising results (successful therapy outcome > 70 %). Please contact Lauren Connolly R.N. or David Seder M.D. if you'd like to learn more.
SETPOINT 2 (Stroke-Related Early Tracheostomy versus 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 Lauren Connolly R.N. or David Seder M.D. if you'd like to learn more.
MISTIE III (Minimally Invasive Surgery Plus rt-PA for Intracerebral Hemorrhage Evacuation)
Investigators: David Seder, M.D.; Richard Riker, M.D.; Jeffrey Florman, M.D.; Robert Ecker, M.D.; Anand Rughani, M.D.
MISTIE III is an NIH funded, international, Phase III, multicenter clinical trial with the primary goal of defining a successful treatment for ICH. The MISTIE III intervention seeks to remove blood from the brain through minimally invasive surgery and intermittent dosing of rt-PA. The study premise is that by removing blood clot faster, injury to the brain will be reduced and the patient's long-term prognosis will improve. Please contact Barbara McCrum R.N. or David Seder M.D. if you'd like to learn more.
Other studies (not 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.