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Funded Clinical Research

clinical research staff

Funded clinical research is directed towards participation in multi or single center trials for the management of stroke, subarachnoid hemorrhage, intracerebral and intraventricular hemorrhage, traumatic brain injury and spinal cord injury.

A clinical research manager, four research coordinators, and an epidemiologist assistant support this research with funding from federal, industry, and private grants.

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Clinical Research Staff

aldrich

Charlene Aldrich, RN, MSN - Clinical Research Manager  

  • Masters in Nursing
  • Lead Research Coordinator for Neurosurgery Research
  • Coordinated multiple Neurosurgical research studies
  • Qualified in grant proposal writing and billing management

Amy Roach

Amy Roach, B.A. - Clinical Research Assistant  

  • Bachelor of Arts in Psychology (Summa Cum Laude)
  • Involved in multiple clinical trials for brain and spine injuries (traumatic and acute)

shannon

Shannon Coveney, B.S. – Clinical Research Assistant  

  • Bachelor of Arts in Psychology

 


kaitlyn

Kaitlyn Henry, B.S. – Clinical Research Assistant  

  • Bachelor of Arts in Neuroscience

 

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Overview of Neurosurgical Clinical Research

  • Coordinates research protocols from large multicenter studies and Principal Investigator initiated studies
  • Manages multiple grants from the National Institutes of Health (NIH) and the Department of Defense (DoD)
  • Directs several current protocols engendered from the laboratory of Dr. Marc Simard M.D., Ph.D., which are now in the clinical phase:
    • Serum biomarkers in spinal cord injury
    • Innovative use of Glyburide, a drug used in the treatment of diabetes, for the treatment of traumatic brain injury and ischemic stroke
     

Clinical Research Studies for Spinal Cord Injury  

Quick Title  

Expanded Title  

Principal Investigator  

Sponsor  

ACORDA 

A double-blind, placebo-controlled study of AC105 (magnesium chloride) in patients with acute traumatic spinal cord injury

Bizhan Aarabi, MD

Acorda Therapeutics

AOSpine Outcomes 

Self-report outcomes in traumatic spinal cord injury

Bizhan Aarabi, MD

AOSpine

NACTN 

North American Clinical Trial Network for spinal cord injury (Registry)

Bizhan Aarabi, MD

Christopher and Dana Reeve Foundation

RISCIS 

Multi-center, randomized, placebo-controlled, double-blind trial of efficacy and safety of Riluzole in acute spinal cord injury started within 12 hours of injury

Bizhan Aarabi, MD

AOSpine International; Christopher and Dana Reeve Foundation; Rick Hansen Institute

HuCNS-SC  

A Single-Blind, Randomized, Parallel Arm,
Phase II Proof-of-Concept Study of the Safety and Efficacy
of HuCNS-SC Transplantation in
Cervical Spinal Cord Injury

Bizhan Aarabi, MD

StemCell Inc

Serum Biomarkers 

Serum Biomarkers in Spinal Cord Injury

Marc Simard, MD

Department of Defense (DOD), United States Army Medical and Materiel Command (USAMRMC)

 

Clinical Research Studies for Traumatic Brain Injury  

Quick Title  

Expanded Title  

Principal Investigator  

Sponsor  

Glyburide 

Randomized, double-blind, placebo-controlled, multi-institutional study of IV RP-1127 (Glyburide for injection) begun within 10 hours of traumatic brain injury

Howard Eisenberg, MD

Department of Defense (DoD) and U.S. Army

 

Clinical Research Studies for Subarachnoid Hemorrhage (SAH) and Stroke  

Quick Title  

Expanded Title  

Principal Investigator  

Sponsor  

CLEAR III 

Clot Lysis: Evaluating accelerated resolution of intraventricular hemorrhage, Phase III

Francois Aldrich, MB, ChB, MMed, FCS

National Institutes of Health (NIH)

i-DEF  

Deferoxamine mesylate in intracerebral hemorrhage - A phase II prospective, multi-center, double-blind, randomized, placebo-controlled, phase II clinical trial

Francois Aldrich, MB, ChB, MMed, FCS

National Institute of Neurological Disorders and Stroke (NINDS)

MISTIE 

Minimally invasive surgery plus rt-PA for intracranial hemorrhage evacuation

Francois Aldrich, MB, ChB, MMed, FCS

National Institutes of Health (NIH)

MRP 

Myeloid-related protein 8/14 involvement in the pathology of aneurysmal subarachnoid hemorrhage

J. Marc Simard, MD, PhD and Narlin Beaty, MD

AANS/CNS Cerebrovascular Section

 

Clinical Research Study for Movement Disorders 

Quick Title  

Expanded Title  

Principal Investigator  

Sponsor  

ET002  MRgFUS  

A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects

Howard Eisenberg, MD

InSightec

 

Clinical Research Studies for Ischemic Stroke  

Quick Title  

Expanded Title  

Principal Investigator  

Sponsor  

GAMES  

Glyburide advantage in malignant edema and stroke

Carolyn Cronin, MD

Remedy Pharmaceuticals

SHINE 

Stroke hyperglycemia insulin network effort (SHINE) trial protocol

Marcella Wozniak, MD

National Institute of Neurological Disorders and Stroke (NINDS)

 

Clinical Research Study for Aneurysms  

Quick Title  

Expanded Title  

Principal Investigator  

Sponsor  

Edge 

EG-1962 and nimodipine vs. placebo in aneurysm

Francois Aldrich, MB, ChB, MMed, FCS

Edge Therapeutics, Inc.

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Current Clinical & Non-Clinical Research Grants

Dr. Aarabi

Bizhan Aarabi, M.D.  

Principal Investigator
NACTN: North American clinical trials network for treatment of spinal cord injury
Sponsor: Christopher and Dana Reeve Foundation
Date: 2004 - present

Principal Investigator
ACORDA: Double-blind, placebo-controlled study of AC105 (magnesium chloride) in patients with acute traumatic spinal cord injury
Sponsor: Acorda Therapeutics
Date: 2013 – present

Principal Investigator
AOSpine Outcomes: Self-report outcomes in traumatic spinal cord injury
Sponsor: AOSpine
Date: 2013 – present

Principal Investigator
RISCIS: Multicenter, randomized, placebo-controlled, double-blind trial of efficacy and safety of Riluzole in acute spinal cord injury started within 12 hours of injury
Sponsors: AOSpine International, Christopher and Dana Reeve Foundation, and Rick Hansen Institute
Date: 2013 – present

Co-Principal Investigator
Glyburide: A Randomized, Placebo-Controlled Treatment Study of Glyburide in Ischemic Stroke
Sponsor: Department of Defense
Date: 2011 to present 

Co-Principal Investigator
Serum Biomarkers: Correlation between biomarkers, MR imaging, and six month ASIA exam in spinal cord injury patients
Sponsor: Department of Defense
Date: 2011 to present

Co-Principal Investigator
CNRM: Evaluation and diagnosis of potential research subjects with traumatic brain injury (Registry for NIH/CNRM sites)
Sponsor: National Institutes of Health - Center for Neuroscience and Regenerative Medicine (CNRM)
Date: 2013 - present


Dr. Aldrich

E. Francois Aldrich, M.D.  

Principal Investigator
CLEAR: Clot Lysis – Evaluating accelerated resolution of intraventricular hemorrhage, phase III
Sponsor: National Institutes of Health
Date: 2004 - present

Principal Investigator
Edge: EG-1962 and nimodipine vs. placebo in aneurysm
Sponsor: Edge Therapeutics, Inc.
Date: 2013 – present

Principal Investigator
Hi-DEF: Deferoxamine mesylate in intracerebral hemorrhage, a phase II prospective, multi-center, double-blind, randomized, placebo-controlled, phase II clinical trial
Sponsor: National Institutes of Health, NINDS
Date: 2013 – present

Principal Investigator
MISTIE: Minimally invasive surgery plus rt-PA for intracranial hemorrhage evacuation
Sponsor: National Institutes of Health
Date: 2005 - present

Co-Principal Investigator
Glyburide: A randomized, placebo-controlled treatment study of glyburide in ischemic stroke
Sponsor: Department of Defense
Date: 2011 to present


Dr. Eisenberg

Howard M. Eisenberg, M.D.  

Principal Investigator
Glyburide: A Randomized, Placebo-Controlled Treatment Study of Glyburide in Ischemic Stroke
Sponsor: Department of Defense
Date: 2011 to present

Principal Investigator
CNRM: Evaluation and diagnosis of potential research subjects with traumatic brain injury (Registry for NIH/CNRM sites)
Sponsor: National Institutes of Health (NIH) - Center for Neuroscience and Regenerative Medicine (CNRM)
Date: 2013 – present

Principal Investigator for the Clinical Site
SHINE: Stroke hyperglycemia insulin network effort (SHINE) trial protocol
Sponsor: National Institutes of Health, NINDS
Date: 2013 – present

Principal Investigator
Tremor: ExAblate MRI for essential tremor
Sponsor: InSightec
Date: Pending


Dr. Gerzanich

Vladimir Gerzanich, M.D., Ph.D.  

Principal Investigator
Role of TRP channels in secondary injury after brain edema
Sponsor: National Institutes of Health, NINDS
Date: 2011 - present

Principal Investigator
TRPM4 channel in spinal cord injury
Sponsor: National Institutes of Health, NINDS
Date: 2008 - present

Co-Principal Investigator
Sulfonylurea receptor 1 (SUR1) – A novel therapeutic target in ischemic stroke
Sponsor: National Institutes of Health, NHLBI
Date: 2006 – present


Charles Sansur

Charles A. Sansur, M.D., M.H.Sc.  

Co-Principal Investigator
ACORDA: Double-blind, placebo-controlled study of AC105 (magnesium chloride) in patients with acute traumatic spinal cord injury
Sponsor: Acorda Therapeutics
Date: 2013 – present

Co-Principal Investigator
RISCIS: Multicenter, randomized, placebo-controlled, double-blind trial of efficacy and safety of Riluzole in acute spinal cord injury started within 12 hours of injury
Sponsors: AOSpine International, Christopher and Dana Reeve Foundation, and Rick Hansen Institute
Date: 2013 – present


Dr. simard

J. Marc Simard, M.D., Ph.D.  

Principal Investigator
MRP: Myeloid-related protein 8/14 involvement in the pathology of aneurysmal subarachnoid hemorrhage
Sponsor: AANS/CNS Cerebrovascular Section
Date: 2012 – present

Principal Investigator
Serum Biomarkers: Correlation between biomarkers, MR imaging, and six month ASIA exam in spinal cord injury patients
Sponsor: Department of Defense
Date: 2011 to present

Principal Investigator
Pathological role of the SUR1-regulated NC (Ca-ATP) channel in cortex after subarachnoid hemorrhage
Sponsor: National Institutes of Health
Date: 2009 – present

Principal Investigator
Spinal cord injury, progressive hemorrhagic necrosis and the NC (Ca-ATP) channel
Sponsor: National Institutes of Health
Date: 2009 – present

Principal Investigator
Sulfonylurea receptor 1 (SUR1) – A novel therapeutic target in ischemic stroke
Sponsor: National Institutes of Health
Date: 2005 – present

Partnering Principal Investigator
MINIR-II: Minimally invasive neurosurgical intracranial robot
Sponsor: National Institutes of Health, NIBIB
Date: 2012 - present 

Principal Investigator
Role of SUR1 in secondary hemorrhage following traumatic brain injury
Sponsor: Department of Veterans Affairs
Date: 2010 – present

Principal Investigator
Brain injury due to transcranial versus transthoracic blast exposure
Sponsor: Department of Veterans Affairs
Date: 2013 – present  

Co-Principal Investigator
Edge: EG-1962 and nimodipine vs. placebo in aneurysm
Sponsor: Edge Therapeutics, Inc.
Date: 2013 – present

Co-Principal Investigator
Role of TRP channels in secondary injury after brain trauma
Sponsor: National Institutes of Health, NINDS
Date: 2011 - present

Co-Principal Investigator
TRPM4 channel in spinal cord injury
Sponsor: National Institutes of Health, NINDS
Date: 2008 - present

Co-Principal Investigator
CLEAR: Clot Lysis – Evaluating accelerated resolution of intraventricular hemorrhage, phase III
Sponsor: National Institutes of Health
Date: 2004 - present

Co-Principal Investigator
MISTIE: Minimally invasive surgery plus rt-PA for intracranial hemorrhage evacuation
Sponsor: National Institutes of Health
Date: 2005 - present

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