Stereotactic Laser Ablation for Temporal Lobe Epilepsy

Temporal Lobe Epilepsy Clinical Trial

— SLATE  

Official title:

Stereotactic Laser Ablation for Temporal Lobe Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02844465
• Other study ID #: CS-05000
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2023

Study information

• Verified date: March 2024
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Temporal Lobe
• Temporal Lobe Epilepsy

Intervention

Device:
• Visualase MRI-Guided Laser Ablation
All subjects will undergo MRI-guided laser ablation of the amygdala and hippocampus with the Visualase System.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Virginia	Charlottesville	Virginia
United States	University of Chicago	Chicago	Illinois
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	Northwell Health	Great Neck	New York
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Louisville Hospital	Louisville	Kentucky
United States	University of Miami	Miami	Florida
United States	Rutgers University - Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Columbia University Medical Center	New York	New York
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Stanford University	Palo Alto	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Oregon Health & University Science	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California, San Francisco	San Francisco	California
United States	University of Washington Harborview	Seattle	Washington
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of qualifying adverse events		12 months
Primary	Seizure freedom, defined as Engel Classification of Postoperative Outcome Class I		12 months
Secondary	Seizure freedom compared to historical controls		12 months
Secondary	Seizure freedom, including subjects retreated with Visualase		12 months
Secondary	Change in Boston Naming Test scores		Baseline and 12 months
Secondary	Change in Rey Auditory Verbal Learning Test scores		Baseline and 12 months
Secondary	Change in Short Form-36 (SF-36) Health Survey scores		Baseline and 12 months
Secondary	Change in Quality of Life in Epilepsy (QOLIE-31) scores		Baseline and 12 months