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Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE)

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ClinicalTrials.gov Identifier: NCT02844465
Recruitment Status : Recruiting
First Posted : July 26, 2016
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Surgical Technologies ( Medtronic Navigation, Inc. )

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

Condition or disease Intervention/treatment Phase
Temporal Lobe Epilepsy Device: Visualase MRI-Guided Laser Ablation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Laser Ablation for Temporal Lobe Epilepsy
Actual Study Start Date : December 2016
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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:
  • Visualase System
  • Visualase procedure
  • Laser interstitial thermal therapy
  • Stereotactic laser ablation




Primary Outcome Measures :
  1. Incidence of qualifying adverse events [ Time Frame: 12 months ]
  2. Seizure freedom, defined as Engel Classification of Postoperative Outcome Class I [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Seizure freedom compared to historical controls [ Time Frame: 12 months ]
  2. Seizure freedom, including subjects retreated with Visualase [ Time Frame: 12 months ]
  3. Change in Boston Naming Test scores [ Time Frame: Baseline and 12 months ]
  4. Change in Rey Auditory Verbal Learning Test scores [ Time Frame: Baseline and 12 months ]
  5. Change in Short Form-36 (SF-36) Health Survey scores [ Time Frame: Baseline and 12 months ]
  6. Change in Quality of Life in Epilepsy (QOLIE-31) scores [ Time Frame: Baseline and 12 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844465


Contacts
Contact: Guy Alvarez, PhD rs.slatestudy@medtronic.com

Locations
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: Bharati Sanjanwala, MS    650-721-2830    bharatis@stanford.edu   
Contact: Anthony Bet    650-683-5823    abet0915@stanford.edu   
Principal Investigator: Casey Halpern, MD         
University of California, San Francisco Active, not recruiting
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Pamela David Gerecht, PhD    303-724-4134    Pamela.DavidGerecht@ucdenver.edu   
Principal Investigator: Aviva Abosch, MD, PhD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Letitia Fisher    305-243-7108    lfisher@med.miami.edu   
Principal Investigator: Jonathan Jagid, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Yvan Bamps, PhD    404-778-7673    yvan.bamps@emory.edu   
Principal Investigator: John T. Willie, MD, PhD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Matthew Johnson    773-702-1096    mjohnson31@surgery.bsd.uchicago.edu   
Principal Investigator: Peter C. Warnke, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Abigail Klaehn, RN, BSN    317-963-7440    aklaehn@iupui.edu   
Contact: Lauren Perrey, RN, BSN    (317) 963-7505    lperrey@iupui.edu   
Principal Investigator: Vicenta Salanova, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Tony Stanfield    415-502-0965    astanfi1@jhmi.edu   
Contact: Joon-Yi Kang, MD    410-955-2822      
Principal Investigator: Joon-Yi Kang, MD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Kelly Tundo, RN, BSN    313-916-1102    kciach1@hfhs.org   
Principal Investigator: Jason Schwalb, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Karla Crockett    507-538-9140    crockett.karla@mayo.edu   
Principal Investigator: Jamie Van Gompel, MD         
United States, New Jersey
Rutgers University - Robert Wood Johnson Medical School Active, not recruiting
New Brunswick, New Jersey, United States, 08901
United States, New York
Northwell Health Recruiting
Great Neck, New York, United States, 11021
Contact: Denise K. McDermott    516-297-0864    dmcdermo@northwell.edu   
Principal Investigator: Ashesh D Mehta, MD, PhD         
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Jessica P. Dimos    336-716-8694    jdimos@wakehealth.edu   
Principal Investigator: Gautam Popli, MD         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Leah Shabo    215-503-3213    Leah.Shabo@jefferson.edu   
Principal Investigator: Michael Sperling, MD         
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Jessica A. Johnson, MSN, NP-C    713-500-5443    Jessica.A.Johnson@uth.tmc.edu   
Principal Investigator: Nitin Tandon, MD         
United States, Washington
University of Washington Harborview Active, not recruiting
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Medtronic Navigation, Inc.
Investigators
Principal Investigator: Robert Gross, MD, PhD Emory University
Principal Investigator: Michael Sperling, MD Thomas Jefferson University

Responsible Party: Medtronic Navigation, Inc.
ClinicalTrials.gov Identifier: NCT02844465     History of Changes
Other Study ID Numbers: CS-05000
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to share individual participant data, but aggregate data for all primary and secondary endpoints will be shared.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Medtronic Surgical Technologies ( Medtronic Navigation, Inc. ):
epilepsy
laser ablation
Visualase
laser interstitial thermal therapy

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Temporal Lobe
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial