Stereotactic Laser Ablation for Temporal Lobe Epilepsy (Slate)
NCT ID: NCT02844465
Last Updated: 2025-01-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
167 participants
INTERVENTIONAL
2016-12-31
2023-12-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Visualase MRI-guided laser ablation procedure
Visualase MRI-Guided Laser Ablation
All subjects will undergo MRI-guided laser ablation of the amygdala and hippocampus with the Visualase System.
Interventions
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Visualase MRI-Guided Laser Ablation
All subjects will undergo MRI-guided laser ablation of the amygdala and hippocampus with the Visualase System.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Gross, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Michael Sperling, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
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Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Stanford University
Palo Alto, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Rutgers University - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Northwell Health
Great Neck, New York, United States
Columbia University Medical Center
New York, New York, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Ohio Health Research Institute
Columbus, Ohio, United States
Oregon Health & University Science
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
University of Washington Harborview
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CS-05000
Identifier Type: -
Identifier Source: org_study_id
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