Clinician-Initiated Research Projects
MMC is one of four sites in New England participating in a Phase III/Pivotal trial for patients with newly diagnosed glioblastoma multiforme (GBM). The NovoCure multi-center trial prospectively compares patients treated with the Novo TTF-100A with temozolomide to patients treated with temozolomide alone. The treatment is based on non-invasive, chronic applications of alternating electric fields to the tumor site using insulated surface electrodes. Results from in vitro and pilot studies have demonstrated prolonged time to disease progression and extension of survival. Rajiv Desai, MD, of MMP-Neurosurgery & Spine, is the Principal Investigator on this trial. Novocure Trial Information
CLEAR III is an 500-patient Phase-III randomized clinical trial for patients that have a type of hemorrhagic stroke with bleeding into the ventricular system of the brain. Maine Medical Center is one of the hospitals that will use a recombinant tissue plasminogen activator (Activase) to quickly remove this blood from the ventricles. It is the hope of the over 70 academic medical centers in this international clinical trial that this may prove to be a better way to treat this brain injury. The Maine Medical Center principal investigator is Dr. David Seder and the trial is funded by the National Institute of Health. Please contact Barbara McCrum RN (firstname.lastname@example.org) or David Seder MD (email@example.com) if you'd like to learn more.
MISTIE-III recently received funding from the NIH and Maine Medical Center is on the NIH application as a participating site. It is the sister study of CLEAR-III which we are currently an actively enrolling site. MISTIE-III uses image-guided catheters that are placed into deep intracerebral hemorrhages and tPA is used to break apart and extract the hematomas. Please contact Barbara McCrum RN (firstname.lastname@example.org) or David Seder MD (email@example.com) if you'd like to learn more.
Maine Medical Center's Neuroscience Institute has been selected to participate in a new multi-center, randomized controlled trial which is one of the largest global studies to examine the adjunctive use of mechanical thrombectomy during the early stages of acute ischemic stroke onset. MMC is one of 40 US sites plus 20 overseas. According to the American Heart Association, acute ischemic stroke is the leading cause of disability and the fourth most common cause of death in the United States. The SWIFT PRIME study will examine acute ischemic stroke patients treated with either intravenous tissue plasminogen activator (IV tPA) alone or IV tPA in combination with Covidien’s Solitaire™ FR Revascularization Device. The study hopes to enroll 800 patients across 60 centers globally, and will also include an extensive health economics analysis. Please contact Barbara McCrum RN (firstname.lastname@example.org) or Debbie Cushing RN (email@example.com) if you'd like to learn more.
ATACH II is a five (5) year, multi-center, randomized, controlled, Phase-III trial to determine the efficacy of early, treatment of blood pressure using intravenous nicardipine for acute hypertension in subjects with spontaneous intracerebral hemorrhage, a type of stroke. The hypothesis is that this treatment will reduce the likelihood of death or disability. The Maine Medical Center principal investigator is Dr. David Seder and the trial funded by the National Institute of Health. Please contact Barbara McCrum RN (firstname.lastname@example.org) or David Seder MD (email@example.com) if you'd like to learn more
GAMES-RP is a randomized, multi-center, prospective, double blind, two-stage, adaptive Phase II trial that uses intravenous glyburide (RP-1127) in patients with a severe ischemic stroke who are likely to develop malignant edema (swelling of the brain). Maine Medical Center, as a participating site, will help to enroll up to 240 patients. The Maine Medical Center principal investigator is Dr. Paul Muscat is and the trial is sponsored by Remedy, Inc. Please contact Barbara McCrum RN (firstname.lastname@example.org) or Paul Muscat MD (email@example.com) if you'd like to learn more.
The Relievant SMART study is a prospective, randomized, double-blind trial to treat chronic low back pain with ablation therapy of the basivertebral nerve in patients with degenerative disc disease. The SMART study will advance knowledge and understanding of the causes of low back pain and validate a novel therapeutic method. The Maine Medical Center principal investigator is Dr. Douglas Buxton. For more information about this trial, please contact the study coordinator, Debbie Cushing RN, (firstname.lastname@example.org).
Heidi Henninger, MD, of Maine Neurology, is the Prinicipal Investigator for the following two clinical trials.
- The LEAP trial is for patients age 65 and older who are unhappy with their seizure medications. The trial offers patients a chance to change from their current seizure medication to Lamictal XR. This drug is known to be efficacious for both partial and generalized seizures. The study is looking at tolerability, pharmacokinetics and appropriate dosing specifically for the older patient.
- This study is for patients with uncontrolled epilepsy, age 16 - 70, who are only on one drug and are having more than 2 seizures per month. The patients will be offered a chance to crossover to a new antiepileptic drug, Lacosamide, in monotherapy to see if it is equally or more effficacious/tolerable than their current medication. Dr. Henninger has previously participated in a NIH funded trial of natural progesterone for women with epilepsy.
Clinician-Initiated Research Projects:
Project Title: Good Grade Sub-Arachnoid Hemorrhage Routinely Treated In a Neuro-Stepdown Unit
Principle Investigator- David Seder, MD
Approved Budget: $7,220
Project Title: Maine Cool- A Regional Collaborative Therapeutic Hypothermia Project
Principle Investigator - Richard Riker, MD
Approved Budget: $36,246
Status: In progress
Project Title: Identification of Chemo-radiation Resistant Stem Cells in Recurrent Glioblastoma Multiforme
Principal Investigator: Chiara Battelli, MD, PhD Approved Budget: $ 22,827
Project Title: Effect of Induced Hypertension on Cerebral Oxygen Utilization in Encephalopathic Survivors of Cardiac Arrest
Principal Investigator: David Seder, MD
Approved Budget: $ 44,002
Status: In progress
Project Title: Cthrc1, A Possible Diagnostic Marker of Neural Tumor Progression and Vascularization
Principal Investigator: Volkhard Lidner, MD, PhD
Approved Budget: $ 26,378
Project Title: Proteomic Characterization of Cerebrospinal Fluid (CSF) in Patients with Lyme Meningitis by High Resolution LC-Mass Spectrometry (MS/MS)
Principal Investigator: Rob Smith, MD
Approved Budget: $ 8,546
Project Title: Predictors of Return to Work in Worker's Compensation Patients Following Spine Surgery
Principle Investigator: John Pier, MD, MMP Neurosurgery and Spine
Approved Budget: Phase 1: $1,500
Project Title: Creation of MMC Carotid Tissue Bank
Principal Investigator: John Belden, MD
Approved Budget: $ 5,800
Project Title: Therapeutic Hypothermia Research Group
Principal Investigator: Richard Riker, MD
Approved Budget: $29,350
Status: In progress
Project Title: Objective CT Assessment of Hydrocephalus
Principal Investigator: Jeff Florman, MD (PI); Jeff Hamm, PA
Approved Budget: $ 9,354
Project Title: Assessing the Accuracy and Inter-Rater Reliability of Bedside Optic Nerve Sonography in Healthy Volunteers
Principal Investigator: Michael Gibbs, MD; Tony Owens, MD; Meghan Lindstrom, MD
Approved Budget: $ 10,000