Help make an impact on epilepsy treatment. The SLATE clinical study for drug-resistant temporal lobe epilepsy is enrolling subjects. Clinical trials are key to advancing the treatment of epilepsy. And we rely on volunteers for every trial.
For individuals with uncontrolled seizures, participation in a new clinical study for drug-resistant epilepsy may be an option. Participants may be compensated for time and/or travel and Medtronic will cover the cost of the study device and any tests or procedures done for the study.
A clinical study collects data through strict scientific methods to explore whether a medical strategy, treatment or device is safe, effective and/or beneficial for people.
The SLATE study is evaluating the Medtronic Visualase™ MRI-guided laser ablation system for the treatment of mesial temporal lobe epilepsy (MTLE). Visualase™ stereotactic laser ablation is a minimally invasive procedure that targets and destroys areas of abnormal brain tissue.
During the procedure the patient is in a magnetic resonance imaging (MRI) scanner that allows the surgeon to see where to insert a tiny laser fiber through a small hole and into the brain. The laser heats and destroys the abnormal tissue, while preserving the surrounding healthy tissue.
The Visualase™ system is currently considered an investigational device for treatment of drug-resistant MTLE. The FDA has cleared the use of the Visualase™ system in neurosurgery and other surgical specialties.
Individuals may qualify to participate in this study if they have mesial temporal lobe epilepsy (MTLE) and uncontrolled seizures.
For those who qualify for the study and decide to participate, Medtronic will pay for the study device and any tests or procedures done just for the research study. However, participants or their insurance may be billed for standard medical care. Participants may be compensated for time and/or travel to study appointments.
The first step is to schedule an appointment to determine eligibility to participate. Those who are eligible will be asked to review the study informed consent form. The informed consent form outlines the study procedures as well as the risks and benefits of participating in the SLATE trial.
Those who qualify and decide to participate may have mental and cognitive function tests, an MRI, and an eye exam. Then, participants will have the Visualase™ procedure and come back to the study center approximately four times over 12 months for checkups, additional mental and cognitive function tests, eye exams, and MRI scans.
Participants must be willing to:
Palo Alto, California, United States, 94305
Recruiting Contact: Bharati Sanjanwala, MS
Recruiting Contact: Anthony Bet
Principal Investigator: Casey Halpern, MD
San Francisco, California, United States, 94143
Recruiting Contact: Valerie Lu
Principal Investigator: Robert Knowlton, MD
Aurora, Colorado, United States, 80045
Recruiting Contact: Pamela David Gerecht, PhD
Principal Investigator: Steven G. Ojemann, MD
Baltimore, Maryland, United States, 21287
Recruiting Contact: Tony Stanfield
Recruiting Contact: Joon-Yi Kang, MD
Principal Investigator: Joon-Yi Kang, MD
Lebanon, New Hampshire, United States, 03766
Recruiting Contact: Charlotte Jeffreys
Principal Investigator: Joshua Aronson, MD
New Brunswick, New Jersey, United States, 08901
Recruiting Contact: Asha Cilly, MSN
Principal Investigator: Stephen Wong, MD
Winston-Salem, North Carolina, United States, 27157
Recruiting Contact: Valerie Woodard
Principal Investigator: Gautam Popli, MD
Philadelphia, Pennsylvania, United States, 19107
Recruiting Contact: Aaron Roberts
Principal Investigator: Michael Sperling, MD
Houston, Texas, United States, 77030
Recruiting Contact: Jessica A. Johnson, MSN, NP-C
Principal Investigator: Nitin Tandon, MD
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.
Caution: Federal Law (USA) restricts these devices for sale by or on the order of a physician. Refer to product instruction manual/package insert for instructions, warnings, precautions and contraindications. Healthcare professionals must review the product technical manual prior to use for detailed disclosure.
For further information, please contact Medtronic at (866) 493-8989.
WHO Fact Sheet No.999: Epilepsy. Accessed June 2014.
Tian II, Boring M, Kobau R, Zack MM. Croft JB. Active epilepsy and seizure control in adults—United States. 2013 and 2015. MMWR Morb Mortul Wkiy Rep. 2018;67(15):437-442.
Bordie MJ Epilesia, 54 (Suppl.S2): 5-8, 2013.