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.


ASCENT - ASCI Study

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN 13837 Injection in Adult Subjects with Acute Spinal Cord Injury.

Status:

This is a clinical study that is currently enrolling subjects

Sponsor:

Asubio Pharmaceuticals, Inc.

Principal Investigator at UK:

Karin Swartz, MD

Purpose:

The purpose of this study is to evaluate the efficacy of SUN13837 Injection versus placebo in acute spinal cord injury (ASCI) subjects by a comparison of the proportion of SUN13837-treated subjects and placebo-treated subjects who are defined as responders. A responder, based on baseline cervical American Spinal Injury Association Impairment Scale (AIS) grade, is defined as a subject who has reached the following outcome at Day 112 (±7 days) as described below:

For cervical AIS A subjects at baseline: an improvement of 2 or more motor levels from baseline on either the right or left side. Motor level is determined from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Scale

For cervical AIS B or C subjects at baseline: a total Lower Extremity Motor Score (LEMS) of 40 or more points, as determined from the ISNCSCI Scale

Condition:

Acute Spinal Cord Injury 

Intervention:

Drug: SUN13837 injection, 1.0 mg/kg, daily for 28 doses
Drug: Placebo, volume equivalent to 1.0 mg/kg dose, daily for 28 dos

Drug Being Studied:

SUN13837 injection; 100 mg single-use vials (100 mg/20 mL); 1.0 mg/kg; IV bolus injection, daily for 28 doses.

 

Phase:

Phase 2

 

More Information:

http://www.clinicaltrials.gov/ - ClinicalTrials.gov identifier: NCT01502631 

Contact:

Mary Faulkner, UK Neurosurgery Clinical Research Study Coordinator

Email: mffaul2@email.uky.edu

Phone: (859)218-5006

 


The DISCOVER™ Study

Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)

A Multi-Center, Prospective, Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease.

Status:

This study is ongoing, but not recruiting participants

Sponsor:

DePuy Spine

Principal Investigator At UK:

Phillip A. Tibbs, MD

Purpose:

The purpose of this study is to determine the safety and effectiveness of the DISCOVER™ Artificial Cervical Disc in the treatment of degenerative disc disease in one level in the cervical spine. 

Condition:

Cervical Degenerative Disc Disease

Intervention:

Device: Arthroplasty (DISCOVER™ Artificial Cervical Disc)
Device: ACDF (allograft with SLIM LOC® Anterior Cervical Plate System)

Product Being Studied:

The ball-and-socket design of the DISCOVER™ Artificial Cervical Disc consists of two endplates constructed from titanium alloy and a polyethylene core.
The DISCOVER™ Artificial Cervical Disc is an investigational device limited by US law to investigational use only at selected clinical research sites.

More Information:

http://clinicaltrials.gov/ct2/show/NCT00432159?term=discover&rank=2

Contact:

Mary Faulkner, UK Neurosurgery Clinical Research Study Coordinator

Email: mffaul2@email.uky.edu

Phone: (859)218-5006


The COAST Study

Treatment of Lumbar Spinal Stenosis with the XSTOP® PEEK Spacer in Moderately Symptomatic Patients.

Status:

This is a clinical study that is currently enrolling subjects

Sponsor:

Medtronic Spine LLC

Principal Investigator At UK:

Phillip A. Tibbs, MD 

Qualifications:

Patients meeting the following criteria may have a condition known as Lumbar Spinal Stenosis (LSS) and may qualify to participate in the COAST Study for the XSTOP® Peek Spacer:

Leg and/or buttock pain (with or without back pain)

Experience relief of that pain when sitting or bending forward

50 years of age or older

Involvement:

This study involves surgically implanting the XSTOP® PEEK spacer in your lower back.  Patients must be willing to enroll in a five-year clinical study.

More Information:

http://thecoaststudy.com/
http://clinicaltrials.gov/ct2/show/NCT00517751?term=The+COAST+Study&rank=2

Contact:

Mary Faulkner, UK Neurosurgery Clinical Research Study Coordinator

Email: mffaul2@email.uky.edu

Phone: (859)218-5006


The ROSE Study

Radiosurgery or Open Surgery for Epilepsy. 

Status:

Closed to Enrollment

Sponsor:

University of California, San Francisco

Principal Investigator At UK:

Thomas Pittman, MD

Purpose:

This Phase III study will compare radiosurgery (focused radiation, Gamma Knife Radiosurgery) with temporal lobectomy (standard surgical care) as a treatment of temporal lobe epilepsy. Patients who have seizures that begin in their temporal lobe that are not controlled with medications will be offered entry into the trial. Patients with a high likelihood of having their seizures controlled with open surgery will have treatment randomized between the standard surgery and radiosurgery.  A prior study has shown that focused radiation (radiosurgery) may also reduce or eliminate seizures arising from the temporal lobe.  The main study hypothesis is that radiosurgery is as safe and effective as temporal lobectomy in treating patients with seizures arising from the medial temporal lobe. 

Condition:

Epilepsy

Procedure:

Radiosurgery 

Temporal Lobectomy

 

More Information:

http://clinicaltrials.gov/ct2/show/NCT00860145?term=NCT00860145&rank=1

Contact:

Mary Faulkner, UK Neurosurgery Clinical Research Study Coordinator

Email: mffaul2@email.uky.edu

Phone: (859)218-5006

 
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