Clinical trial NCT02844465: Stereotactic Laser Ablation for Temporal Lobe Epilepsy (Slate)
Official title: Stereotactic Laser Ablation for Temporal Lobe Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporal Lobe Epilepsy
Keywords: epilepsy
laser ablation
Visualase
laser interstitial thermal therapy
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2016-07-26
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Qualifying Adverse Events
timeFrame: 12 months
measure: Seizure Freedom, Defined as Engel Classification of Postoperative Outcome Class I
timeFrame: 12 months
Secondary outcomes:
measure: Seizure Freedom Compared to Historical Controls (Medical Therapy)
timeFrame: 12 months
measure: Seizure Freedom, Including Subjects Retreated With Visualase
timeFrame: 12 months
measure: Change in Boston Naming Test Scores
timeFrame: Baseline and 12 months
measure: Change in Rey Auditory Verbal Learning Test Scores
timeFrame: Baseline and 12 months
measure: Change in Quality of Life in Epilepsy (QOLIE-31) Scores
timeFrame: Baseline and 12 months
measure: Change in SF-36 Mental Component Score
timeFrame: Baseline and 12 Months
measure: Change in SF-36 Physical Component Score
timeFrame: Baseline and 12 Months
measure: Seizure Freedom Compared to Historical Controls (Open Surgical Resection)
timeFrame: 12 Months
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New Brunswick
country: United States
facility: Rutgers University - Robert Wood Johnson Medical School
state: New Jersey
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Portland
country: United States
facility: Oregon Health & University Science
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: University of Washington Harborview
state: Washington
Study officials:
affiliation: Emory University
name: Robert Gross, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University
name: Michael Sperling, MD
role: PRINCIPAL_INVESTIGATOR
References: