Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE)

The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for mesial temporal epilepsy (MTLE).

Study Overview

• Status: Completed
• Conditions: Temporal Lobe Epilepsy
• Intervention / Treatment: Device: Visualase MRI-Guided Laser Ablation

Detailed Description

The purpose of the study is to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for necrotization or coagulation of epileptogenic foci in patients with intractable mesial temporal lobe epilepsy.

The study will include approximately 150 adult patients with drug-resistant MTLE treated at selected epilepsy centers across the United States. After the Visualase procedure, patients will be followed for 12 months and evaluated for freedom from seizures, quality of life, adverse events, and neuropsychological outcomes.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Senior Clinical Research Manager; Email: rs.slatestudy@medtronic.com

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92688
      • Hoag Memorial Hospital Presbyterian
    • Palo Alto, California, United States, 94305
      • Stanford University
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers University - Robert Wood Johnson Medical School
  • New York
    • Great Neck, New York, United States, 11021
      • Northwell Health
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research Institute
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & University Science
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington Harborview

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• History of drug-resistant mesial temporal lobe epilepsy (MTLE)
• If the subject has a vagus nerve stimulator (VNS), must have failed to achieve sustained seizure freedom with the VNS implanted for at least 6 months
• On stable antiepileptic drugs (AEDs) (and/or stable VNS setting, if applicable) and compliant with medication use
• An average of at least 1 complex partial or secondarily generalized seizure compatible with MTLE per month
• Seizure symptoms and/or auras compatible with MTLE
• Video EEG shows evidence of seizures from one temporal lobe consistent with MTLE
• MRI has evidence consistent with mesial temporal lobe sclerosis
• Willing and able to remain on stable AEDs (and stable VNS setting, if applicable) for 12 months following the Visualase procedure
• Willing and able to comply with protocol requirements
• Able to complete study assessments in English or Spanish language

Exclusion Criteria:

• Unwilling or unable to sign the study informed consent form
• Pregnant or intends to become pregnant during the course of the study
• Currently implanted with a device contraindicating MRI
• Progressive brain lesions and/or tumors not associated with epileptic disease state
• History of previous intracranial surgery for treatment of epileptic seizures
• Persistent extra-temporal or predominant contralateral focal interictal spikes or slowing, or generalized interictal spikes on EEG
• Seizures with contralateral or extra-temporal ictal onset on EEG
• Aura and/or ictal behavior suggest an extra-temporal focus
• MRI evidence of epileptogenic, extra-temporal lesions, dual pathology in the temporal lobe, or contralateral hippocampal MRI increased signal and/or loss of architecture
• If additional testing has been performed, results are discordant with the seizure focus scheduled for ablation
• Non-compliance with AED requirements
• IQ < 70
• Dementia or other progressive neurological disease
• Unstable major psychiatric illness, psychogenic non-epileptic seizures, or medical illness that would contraindicate the Visualase procedure or affect the neuropsychological assessments
• Participation in other research that may potentially interfere with SLATE endpoint(s)
• Allergy to gadolinium

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Visualase MRI-guided laser ablation procedure	Device: Visualase MRI-Guided Laser Ablation; All subjects will undergo MRI-guided laser ablation of the amygdala and hippocampus with the Visualase System.; Other Names: Laser interstitial thermal therapy; Visualase System; Visualase procedure; Stereotactic laser ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of qualifying adverse events	12 months
Seizure freedom, defined as Engel Classification of Postoperative Outcome Class I	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Seizure freedom compared to historical controls	12 months
Seizure freedom, including subjects retreated with Visualase	12 months
Change in Boston Naming Test scores	Baseline and 12 months
Change in Rey Auditory Verbal Learning Test scores	Baseline and 12 months
Change in Short Form-36 (SF-36) Health Survey scores	Baseline and 12 months
Change in Quality of Life in Epilepsy (QOLIE-31) scores	Baseline and 12 months

Collaborators and Investigators

• Sponsor: MedtronicNeuro
• Investigators: Principal Investigator: Michael Sperling, MD, Thomas Jefferson University; Principal Investigator: Robert Gross, MD, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: July 21, 2016
• First Posted (Estimated): July 26, 2016

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: epilepsy; laser interstitial thermal therapy; laser ablation; Visualase
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Epilepsies, Partial; Epilepsy; Epilepsy, Temporal Lobe
• Other Study ID Numbers: CS-05000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to share individual participant data, but aggregate data for all primary and secondary endpoints will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes