Research Efforts

The Department of Neurosurgery at Kentucky Neuroscience Institute strives to stay on the cutting edge of new developments in medical procedures through research. Below are several current research projects to read about

MAVARIC

Magnesium And Verapamil After Recanalization in Ischemia of the Cerebrum in the Kentucky regional population: a clinical and translational study.

Status:

This is a clinical study that is currently enrolling subjects


Principal Investigator-Initiated Study / Principal Investigator:

Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

 

Internal Financial Sponsor:

University of Kentucky College of Medicine (COM) and Center for Clinical and Translational Science (CCTS) Multidisciplinary Value Program (MVP) Grant Program

 

Purpose:

This is a phase I, blinded-outcome, randomized, placebo controlled study to investigate the safety and feasibility of super-selective intra-arterial administration of verapamil and magnesium sulfate immediately following successful endovascular thrombectomy as a potential neuroprotective synergistic therapeutic strategy in emergent large vessel occlusion stroke. This trial represents the first time that magnesium sulfate will be evaluated in human subjects as a superselectively administered neuroprotective agent administered in an acute time frame as an adjunct to intra-arterial thrombectomy. Furthermore, it will represent the first trial to evaluate combinational therapy for acute stroke neuroprotection.

Condition: Acute Ischemic Stroke

Intervention: Magnesium and verapamil after recanalization in ischemia of the cerebrum

Allocation: Randomized

Masking: Single (Outcomes Assessor)

Other information: ClinicalTrials.gov ID # NCT02912663 https://clinicaltrials.gov/ct2/show/NCT02912663?term=02912663&rank=1

Contact: Mary Faulkner, UK Neurosurgery Clinical Research Study Coordinator

Email: MaryFaulkner@uky.edu

Phone: (859) 218-5006

BACTRAC

Blood and Clot Thrombectomy Registry and Collaboration

Status:

This prospective open enrollment clinical registry is currently enrolling subjects.


Principal Investigator-Initiated Study / Principal Investigator:

Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

 

Internal Financial Sponsor:

University of Kentucky Department of Neurology

 

Design:

The study is an open, unblinded, clinical and biologic registry and tissue bank to evaluate specific questions that are novel to understanding stroke in the human condition.

Purpose: The purpose of this prospective open enrollment registry and tissue bank is to evaluate arterial blood and thrombus removed during the standard thrombectomy procedure, which will then be used for the purposes of identifying biological markers, inflammatory cell infiltrates, and biological states in large vessel occlusive stroke in the human condition. The primary objectives are to evaluate the feasibility of obtaining distal clot blood during thrombectomy; develop a group of biosamples (blood and clots) to evaluate novel proteins, cell types, and cytokines in acute ischemic stroke in the human condition, and evaluate specific biomarkers, proteins, and leukocyte populations in stroke in the human condition.

This study represents the first time that thrombectomy technique will be utilized to collect focal blood samples and the clot related brain infarction to understand relationships between the local inflammatory cascade and clinical variables such as age, gender, time from symptoms to thrombectomy, and stroke imaging results. Characterizing these relationships is vital in the formulation of related therapeutics. Issues of gender-differences, age-based variations, and co-morbidities all engender heterogeneity, which plague translation of stroke research from animal to human. By starting with the human condition, the investigators aim to minimize this loss in translation. Overall, this study will have a great impact on our knowledge of stroke pathology. In essence, this could fundamentally change not only how the investigators develop treatment strategies for the stroke patient population but allow us to individualize the treatment dependent on time after stroke, age, sex, and co-morbidities. Molecular techniques that are impractical when delivered systemically could be delivered locally to impede the early inflammation.

Condition: Acute Ischemic Stroke

Participants: Participants must have an acute thromboembolus within an intracranial artery in the anterior circulation (internal carotid, anterior cerebral, middle cerebral), which undergoes mechanical thrombectomy per standard of care.  The study population will include up to 250 subjects.

Intervention: There is no therapeutic intervention involved in this study.

Other information: ClinicalTrials.gov ID # NCT03153683 https://register.clinicaltrials.gov/prs/app/template/EditRecord.vm?epmode=Edit&listmode=Edit&uid=U0000IBN&ts=9&sid=S0006L6Z&cx=-ciqde4

Contact: Mary Faulkner, UK Neurosurgery Clinical Research Study Coordinator

Email: MaryFaulkner@uky.edu

Phone: (859) 218-5006

FEAT

Framing Eighteen Coils in Cerebral Aneurysms Trial

Status: Recruiting

Sponsor: Vanderbilt University Medical Center

Collaborator: Stryker Neurovascular

Principal Investigator at UK:

Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

Purpose:

FEAT is a prospective, randomized trial comparing angiographic outcomes in patients receiving large diameter coils versus those treated solely with coils with a standard diameter.

Hypothesis: Angiographic occlusion at follow-up imaging will be more frequent in patients receiving 0.014-0.0155" platinum coils during embolization compared to those receiving smaller-diameter coils.

Condition: Cerebral Aneurysm

Study Type: Interventional

Study Phase: Not Applicable

Study Design:

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Intervention:

  • Study Procedure: Coil Embolization with larger Diameter Coils (‘Eighteen’)

  • Control Procedure: Coil Embolization with standard Diameter Coils

Study Arms:

  • Active Comparator: Eighteen Coils (0.014-0.0155 inch)

Subjects who randomize to this arm will receive larger diameter bare platinum coils for treatment of their cerebral aneurysm. Subjects in this arm could receive a combination of the following protocol approved intracranial coils depending on the phase: Target XL 360 Standard, Target XL 360 Soft, Target XL 360 Helical, GDC-18 360 Standard, GDC-18 3D, GDC-18 2D, GDC-18 Soft, and/or 0.014-0.0155 inch diameter bare platinum intracranial coils.

Intervention: Procedure: Coil Embolization with larger Diameter Coils

  • Active Comparator: Standard Coils (0.014 inch)

Subjects who randomize to this arm will receive the standard diameter bare platinum coils for treatment of their cerebral aneurysm. Subjects in this arm could receive a combination of the following protocol approved intracranial coils depending on the phase: Target 360 Standard, Target 360 Soft, Target 360 Ultra, Target 360 NANO, Target 360 Helical Ultra, GDC-10 360 Standard SR, GDC-10 360 Soft SR, GDC-10 UltraSoft, GDC-10 3D, GDC-10 2D, GDC-10 Soft 2D SR, GDC-10 Soft SR, GDC-10 Soft, and/or any additional 0.014 inch or less diameter bare platinum intracranial coils.

Intervention: Procedure: Coil Embolization with Standard Diameter Coils

Other information:

ClinicalTrials.gov ID # NCT0165578
https://clinicaltrials.gov/ct2/show/record/NCT01655784?term=FEAT&rank=1

Contact: Mary Faulkner, UK Neurosurgery Clinical Research Study Coordinator

Email: MaryFaulkner@uky.edu

Phone: (859) 218-5006

 

PREMIER

Prospective Study On Embolization Of Intracranial Aneurysms With Pipeline™ Embolization Device

Status:

Active, not recruiting

Sponsor:

Medtronic Neurovascular Clinical Affairs

Principal Investigator at UK:

Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

Purpose:

The purpose of this clinical study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms.

Condition:

Intracranial Aneurysm

Study Design:

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Study Phase:

Not applicable

Intervention:

Device: Pipeline™ Embolization Device/ Pipeline™ Flex Embolization Device

Study Arms:

Experimental: Pipeline™ Embolization Device - treatment with Pipeline™ Embolization Device

Other information:

ClinicalTrials.gov ID # NCT02186561

https://clinicaltrials.gov/ct2/show/record/NCT02186561?term=premier&rank=8

Contact: Mary Faulkner, UK Neurosurgery Clinical Research Study Coordinator

Email: MaryFaulkner@uky.edu

Phone: (859) 218-5006

STABILISER-I

Stroke and Traumatic Acute Brain Injury Line Indicator System for Emergent Recognition

Status: Closed; publication in process

Principal Investigator-Initiated Study / Principal Investigator at UK:

Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

Collaborator:  University of Kentucky

Design:

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility

Study Arm: Lateral Flow Device.

Purpose: In the search for a novel marker of traumatic brain injury or stroke that could be rapidly assessed in blood, the investigators developed a point-of-care (POC) lateral flow device (LFD) that rapidly (< 15 min) detects levels of a biomarker that is released into blood following neuronal injury associated with stroke and traumatic brain injury. The protein's expression in human brain should serve as a useful biomarker of neuronal injury in stroke and traumatic brain injury.

Condition: Ischemic Stroke, Hemorrhagic Stroke, Traumatic Brain Injury

Intervention: Device: Lateral Flow Device

A drop of whole blood from a finger stick is placed on the lateral flow device at two different time points to indicate the presence of a neuronal specific biomarker. The results will also be correlated to severity of clinical and radiographic injury. Separate drops are evaluated similarly for serum levels. The objective is to determine feasibility of a diagnostic tool for stroke (ischemic and hemorrhagic and traumatic brain injury (TBI). No diagnostic results or resulting treatments will be applied to any subject.

Participants: Determine the feasibility of testing whole blood samples from patients with acute stroke (both ischemic and hemorrhagic) and traumatic brain injury being evaluated in the Emergency Department and Inpatient Services at University of Kentucky. No diagnostic or treatment decisions will be based on the results for any patient and the patient will not be told of the results.

Other information: ClinicalTrials.gov ID # NCT02514902 https://clinicaltrials.gov/ct2/show/record/NCT02514902?term=stabiliser&rank=7

Contact: Mary Faulkner, UK Neurosurgery Clinical Research Study Coordinator

Email: MaryFaulkner@uky.edu

Phone: (859) 218-5006

INVEST Feasibility

Minimally Invasive Endoscopic Surgery With Artemis in Patients With Brain Hemorrhage

Status: Study startup at UK; study recruiting nationally

Principal Investigator at UK:

Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

Sponsor:  J. Mocco, Icahn School of Medicine at Mount Sinai, and Penumbra, Inc.

Design: This study will be a prospective, multi-centered trial that will enroll 50 patients at up to 10 United States (US) centers.

Intervention model: Single Group Assignment

Masking: None (Open Label)

Primary Purpose: Treatment

Purpose: The primary objective of this multicenter single arm feasibility study is to provide an assessment of enrollment and follow up feasibility for this patient population being treated with the Artemis Minimally Invasive Surgical Treatment (MIES). Patients who do not qualify for the INVEST Feasibility Study will be referred to the INVEST Registry study.

Condition: Moderate-large volume (20-80 cc) supratentorial intracerebral hemorrhage (ICH).

Participants: Patients with moderate-large volume (20-80 cc) supratentorial intracerebral hemorrhage (ICH) who present within 24 hours of symptom onset. Enrolled patients will receive minimally invasive endoscopic evacuation with the Artemis system.

Indication: The Artemis system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system or cerebrum. In the present study, the researchers propose to investigate the feasibility of studying this patient population for eventual implementation of efficacy trials.

Other information: ClinicalTrials.gov ID # NCT02654015 https://clinicaltrials.gov/ct2/show/record/NCT02654015?term=INVEST&rank=2&view=record

Contact: Mary Faulkner, UK Neurosurgery Clinical Research Study Coordinator

Email: MaryFaulkner@uky.edu

Phone: (859) 218-5006

MIND

A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage

Status: Study startup at UK; study recruiting nationally

Principal Investigator at UK:

Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

Sponsor: Penumbra, Inc.

Design:

  • Allocation: Randomized

  • Intervention Model: Parallel Assignment

  • Intervention Model Description: Subjects will be randomized to either minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management (MIS group) or best medical management alone (2:1) (MM).

  • Masking: Single (Outcomes Assessor)

  • Masking Description: 180 day mRS is blinded

  • Primary Purpose: Treatment

Purpose: The primary objective of this multicenter randomized controlled study is to compare the safety and efficacy of minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device to best medical management for the treatment of intracerebral hemorrhage (ICH).

Condition: Intracerebral hemorrhage (ICH), Cerebral Hemorrhage, Brain Hemorrhage, Cerebral Parenchymal Hemorrhage.

Participants: The target population are patients ≥ 18 and ≤ 80 years of age who have a diagnosis of spontaneous, non-traumatic, intracerebral hemorrhage (ICH) ranging ≥ 20 and < 80 cc, with an associated significant neurological deficit (NIHSS ≥ 6) who do not require emergent open surgical decompression related to uncontrolled intracranial pressure or mass effect.

Intervention:

  • Device: Artemis + Medical Management

Subject will receive best MM in addition to the MIS procedure with Artemis.

  • Other: Best Medical Management Alone (MM)

Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.

Study Arms:

  • Experimental: Artemis + Medical Management (MIS):

    • Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management
      Intervention: Device: Artemis + Medical Management
  • Active Comparator: Best Medical Management Alone (MM)

    • Best medical management alone per standard of care at treating institution
      Intervention: Other: Best Medical Management Alone (MM)

Other information: ClinicalTrials.gov ID # NCT03342664 https://clinicaltrials.gov/ct2/show/record/NCT03342664?term=MIND+Intracerebral+Hemorrhage&draw=2&rank=1

Contact: Mary Faulkner, UK Neurosurgery Clinical Research Study Coordinator

Email: MaryFaulkner@uky.edu

Phone: (859) 218-5006

 

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