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Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE)

Primary Purpose

Temporal Lobe Epilepsy

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visualase MRI-Guided Laser Ablation
Sponsored by
MedtronicNeuro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporal Lobe Epilepsy focused on measuring epilepsy, laser ablation, Visualase, laser interstitial thermal therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hoag Memorial Hospital Presbyterian
  • Stanford University
  • University of California, San Francisco
  • University of Colorado Anschutz Medical Campus
  • University of Miami
  • Emory University
  • University of Chicago
  • Indiana University
  • University of Louisville Hospital
  • Johns Hopkins University
  • Henry Ford Health System
  • Mayo Clinic
  • Dartmouth-Hitchcock Medical Center
  • Rutgers University - Robert Wood Johnson Medical School
  • Northwell Health
  • Columbia University Medical Center
  • Wake Forest Baptist Health
  • Ohio Health Research Institute
  • Oregon Health & University Science
  • Thomas Jefferson University
  • The University of Texas Health Science Center at Houston
  • University of Virginia
  • University of Washington Harborview

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Visualase MRI-guided laser ablation procedure

Outcomes

Primary Outcome Measures

Incidence of qualifying adverse events
Seizure freedom, defined as Engel Classification of Postoperative Outcome Class I

Secondary Outcome Measures

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

Full Information

First Posted
July 15, 2016
Last Updated
September 5, 2023
Sponsor
MedtronicNeuro
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1. Study Identification

Unique Protocol Identification Number
NCT02844465
Brief Title
Stereotactic Laser Ablation for Temporal Lobe Epilepsy
Acronym
SLATE
Official Title
Stereotactic Laser Ablation for Temporal Lobe Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporal Lobe Epilepsy
Keywords
epilepsy, laser ablation, Visualase, laser interstitial thermal therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Visualase MRI-guided laser ablation procedure
Intervention Type
Device
Intervention Name(s)
Visualase MRI-Guided Laser Ablation
Other Intervention Name(s)
Visualase System, Visualase procedure, Laser interstitial thermal therapy, Stereotactic laser ablation
Intervention Description
All subjects will undergo MRI-guided laser ablation of the amygdala and hippocampus with the Visualase System.
Primary Outcome Measure Information:
Title
Incidence of qualifying adverse events
Time Frame
12 months
Title
Seizure freedom, defined as Engel Classification of Postoperative Outcome Class I
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Seizure freedom compared to historical controls
Time Frame
12 months
Title
Seizure freedom, including subjects retreated with Visualase
Time Frame
12 months
Title
Change in Boston Naming Test scores
Time Frame
Baseline and 12 months
Title
Change in Rey Auditory Verbal Learning Test scores
Time Frame
Baseline and 12 months
Title
Change in Short Form-36 (SF-36) Health Survey scores
Time Frame
Baseline and 12 months
Title
Change in Quality of Life in Epilepsy (QOLIE-31) scores
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Gross, MD, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Sperling, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92688
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Facility Name
Rutgers University - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Northwell Health
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Oregon Health & University Science
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
University of Washington Harborview
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to share individual participant data, but aggregate data for all primary and secondary endpoints will be shared.

Learn more about this trial

Stereotactic Laser Ablation for Temporal Lobe Epilepsy

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