Stereotactic Laser Ablation for Temporal Lobe Epilepsy (Slate)

Completed · Not applicable

Conditions studied: Temporal Lobe Epilepsy

In brief

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

Key facts

Study ID

NCT02844465

Run by

MedtronicNeuro

People needed

167

Starts

2016-12-01

Expected to finish

2023-12-11

Last updated by the study team

2025-01-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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