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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 Pharmaceticals, 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 DISCOVERArtificial 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://epilepsysurgery-rosetrial.com/
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