Clinical Study of a Laser Ablation Procedure for Drug-Resistant Epilepsy PARTICIPATION IN THE SLATE STUDY

A clinical study of a laser ablation procedure for drug-resistant epilepsy is currently enrolling eligible patients who would like to participate. Centers participating in the study will research whether laser ablation is a safe and effective treatment option for certain patients with uncontrolled seizures caused by mesial temporal lobe epilepsy (MTLE). 

ABOUT THE LASER ABLATION PROCEDURE

The SLATE study will use the Medtronic VisualaseTM MRI-guided laser ablation system.

The Visualase system is used to perform minimally invasive laser surgery on soft tissue in the body. For neurosurgery, a surgeon guides a thin laser fiber through a small hole into the brain. The laser heats up and destroys a defined area of abnormal brain tissue, minimizing risk of potential damage to surrounding healthy tissue.

The patient is in a magnetic resonance imaging (MRI) scanner throughout the process. This lets the surgeon see an image of the brain, the laser probe placement, and how much tissue is being heated up and destroyed during the procedure.

Visualase is currently considered an investigational device for treatment of drug-resistant MTLE. The FDA has cleared the use of Visualase in neurosurgery and other surgical specialties.

Visualase MRI-Guided Laser Ablation for Minimally Invasive Neurosurgery

Watch an overview animation of the procedure.

ELIGIBILITY

You may qualify to participate in this study if you have mesial temporal lobe epilepsy (MTLE) and uncontrolled seizures. Your epilepsy doctor may have told you about the study and may do some tests to see if you qualify for the study. You may be a candidate if:

  • You are 18 or older.
  • You still have uncontrolled epileptic seizures, even though you have tried at least two antiepileptic drugs.
  • You have had at least 12 seizures in the last year.

To take the next step, please contact a study center for more information. Only a study doctor can decide if you are a candidate for the study.

WHAT THE STUDY INVOLVES

If you qualify for the study and you decide to participate after learning more about the study, you will go to a study center for several visits:

  • Before the Visualase procedure, you will have mental and cognitive function tests and a magnetic resonance image (MRI) scan.
  • You will have the Visualase procedure.
  • You will return four times over 12 months for checkups, mental and cognitive function tests, and MRI scans.

You must be willing to:

  • Take your antiepileptic drugs as prescribed.
  • Complete a daily seizure diary.
  • Complete the required testing and follow-up visits.

Medtronic will pay for the study device and any tests or procedures done just for the research study. However, you or your insurance company may be billed for any tests and procedures that are considered standard medical care.

ABOUT CLINICAL STUDIES

A clinical study is a research study that explores whether a medical strategy, treatment, or device is safe and effective for people. These studies are used to produce the best data available for healthcare decision making.

Clinical studies follow strict scientific standards. These standards protect patients and help produce reliable study results. The clinical study may find that a new strategy, treatment, or device improves patient outcomes, offers no benefit, or causes unexpected harm. All of these results are important because they advance medical knowledge and help improve patient care.

FIND A STUDY CENTER

Contact one of these study centers to see if you qualify and to learn more. Check back for additional updates on sites.

CALIFORNIA

Stanford University

Palo Alto, CA
Casey Halpern, MD
Contact 1: Bharati Sanjanwala
MSTel: 650-721-2830
Email: bharatis@stanford.edu
Contact 2: Anthony Bet
Tel: 650-683-5823
Email: abet0915@stanford.edu

University of California, San Francisco
San Francisco, CA
Robert Knowlton, MD
Contact: Felicia Kuo
Email: Felicia.kuo@ucsf.edu

COLORADO

University of Colorado Anschutz Medical Campus
Aurora, CO
Aviva Abosch, MD, PhD
Contact: Pamela David Gerecht, PhD
Tel: 303-724-4134
Email: Pamela.DavidGerecht@ucdenver.edu

FLORIDA

University of Miami

Miami, FL
Jonathan Jagid, MD
Contact: Letitia Fisher
Tel: 305-243-7108
Email: lfisher@med.miami.edu

GEORGIA

Emory University
Atlanta, GA
Jon T. Willie, MD, PhD
Contact: Yvan Bamps, PhD
Tel: 404-778-7673
Email: yvan.bamps@emory.edu

INDIANA

Indiana University

Bloomington, IN
Vicenta Salanova, MD
Contact:  Abigail Klaehn, RN, BSN
Tel: 317-963-7440
Email: aklaehn@iupui.edu

MARYLAND

Johns Hopkins University

Baltimore, MD
Joon-Yi Kang, MD
Contact: Tony Stanfield or Joon-Yi Kang
Tel: 410-502-0965/410-955-2822
Email: Astanfi1@jhmi.edu

MICHIGAN

Henry Ford Health System

Detroit, MI
Jason Schwalb, MD
Contact: Kelly M. Tundo, RN, BSN
Tel: 313-916-1102
Email: kciach1@hfhs.org

MINNESOTA

Mayo Clinic

Rochester, MN
Jamie Van Gompel, MD
Contact: Karla Crockett
Tel: 507-538-9140
Email: Crockett.Karla@mayo.edu

NEW JERSEY

Rutgers – Robert Wood Johnson Medical School

New Brunswick, NJ
Stephen Wong, MD MS
Contact:  Asha Cilly, MSN, FNP-C
Tel: 732-235-7342
Email: ac1659@rwjms.rutgers.edu

NEW YORK

Columbia University Medical Center

New York, NY
Guy M. McKhann II MD
Contact: Gail Iodice
Tel: 212-305-1038
Email: gd2023@cumc.columbia.edu

Northwell Health
Great Neck, NY
Ashesh D. Mehta, MD. PhD
Contact: Connie Lau, MS, CCRC
Tel: 516-325-7022
Email: clau@northwell.edu

NORTH CAROLINA

Wake Forest Baptist Health

Winston-Salem, NC
Gautam Popli, MD
Contact: Jessica P. Dimos
Tel: 336-716-8694
Email: jdimos@wakehealth.edu

PENNSYLVANIA

Thomas Jefferson University

Philadelphia, PA
Michael Sperling, MD
Contact: Leah Shabo
Tel: 215-503-3213
Email: leah.shabo@jefferson.edu

TEXAS

University of Texas Health Science Center at Houston
Houston, TX
Nitin Tandon, MD
Contact: Jessica A Johnson,MSN, NP-C
Tel: 713-500-5443
Email: Jessica.A.Johnson@uth.tmc.edu

WASHINGTON

University of Washington- Harborview Medical Center

Seattle, WA
John Miller, MD, PhD
Contact:  Gina DeNoble, MS
Tel: 206-744-3624
Email: gdenoble@uw.edu

Important Safety Information

As with any medical device or procedure, serious and even life-threatening risks and side effects can occur. The risks of this investigational therapy are listed in the informed consent document that potential patients review before participating in the study.