Stereotactic Laser Ablation for Temporal Lobe Epilepsy (Slate)
- Conditions
- Temporal Lobe Epilepsy
- Interventions
- Device: Visualase MRI-Guided Laser Ablation
- Registration Number
- NCT02844465
- Lead Sponsor
- MedtronicNeuro
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 167
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Visualase MRI-Guided Laser Ablation Visualase MRI-guided laser ablation procedure
- Primary Outcome Measures
Name Time Method Incidence of Qualifying Adverse Events 12 months The incidence of qualifying device, procedure and/or anesthesia related adverse events. These events must also be moderate or severe and permanent for the following AEs: anxiety, aphasia, blurry vision, depression, diplopia, emotional lability, hemianopia, hemiparesis, memory impairment/difficulty, neurologic deficits, paralysis, psychological/psychiatric complications, quadrantanopia, sensory loss, sleep problems or insomnia. An exact 95% confidence interval (CI) will be calculated to determine if the upper bound of the CI for qualified AEs is less than 40%.
Seizure Freedom, Defined as Engel Classification of Postoperative Outcome Class I 12 months Seizure freedom at 12 months following the Visualase procedure (starting at 30 days post-procedure through 365 days post procedure). Engel Class I: Free of disabling seizures includes subclasses: A. Completely seizure free since surgery, B. Nondisabling simple partial seizures only since surgery, D. Generalized convulsions with antiepileptic drugs (AED) discontinuation only. An exact 95% CI will be calculated to determine if the lower bound of the CI for seizure freedom at 12 months following the Visualase procedure will be greater than 43%. Multiple imputation was used if subject diary data was not compliant. Retreated subjects are treated as failures.
- Secondary Outcome Measures
Name Time Method Seizure Freedom Compared to Historical Controls (Medical Therapy) 12 months Seizure freedom (Engel Class I) compared to historical control for continued medical therapy. It is hypothesized that the seizure freedom at 12 months following the Visualase procedure will be superior to 8% reported in the literature for continued medical therapy. An exact 95% CI for the percentage of subjects who are seizure free will be calculated.
Seizure Freedom, Including Subjects Retreated With Visualase 12 months Seizure freedom (Engel Class I) including subjects who were retreated with Visualase. The outcome after retreatment will count towards the endpoint. It is hypothesized that the lower bound of the 95% CI for seizure freedom at 12 months following the Visualase procedure, including subjects retreated with Visualase, will be greater than 43%. Subjects retreated with Visualase will count toward the secondary efficacy endpoint based on their outcome after retreatment. If they have become seizure free and have reached 12 months follow-up from time of retreatment, they are counted as seizure free. Otherwise, they will count as not seizure free. An exact 95% CI will be calculated to determine if the lower bound of the CI for seizure freedom at 12 months following a subject's last Visualase procedure, including patients retreated with Visualase, will be greater than 43%.
Change in Boston Naming Test Scores Baseline and 12 months Within-subject change of Boston Naming Test score (English language version) from baseline to 12 months following the Visualase procedure. The Boston Naming Test is a neuropsychological assessment tool to measure confrontational word retrieval. The test contains 60 line drawings graded in difficulty which the participants need to name. The total score ranges from 0-60 with a higher score meaning a better outcome.
Change in Rey Auditory Verbal Learning Test Scores Baseline and 12 months Within-subject change of Rey Auditory Verbal Learning Test (RAVLT) 5-Trial Total score (English language version) from baseline to 12 months following the Visualase procedure. It is used for assessing episodic memory by providing scores for evaluating different aspects of memory. The RAVLT presents a list of 15 words across 5 consecutive trials. The list is read to the participant and the participant is asked to recall as many words as possible. This is repeated for 5 consecutive trials. The scores range from 0-75 with a higher score indicating a better outcome.
Change in Quality of Life in Epilepsy (QOLIE-31) Scores Baseline and 12 months Within-subject change of the QOLIE-31 score (English language version) from baseline to 12 months following the Visualase procedure, categorized as -1 if the decrease is clinically significant (\<= -11.8), categorized as 0 if not clinically significant (-11.7 to +11.7), and categorized as +1 if the increase is clinically significant (\>= 11.8). The QOLIE-31 evaluates a participant's quality of life in relation to their epilepsy. It is used to asses a person's overall wellness, including their social functioning and cognitive impact. The QOLIE scores range from 0-100 with a higher score meaning a better outcome.
Change in SF-36 Mental Component Score Baseline and 12 Months Within-subject change of short form (SF)-36 quality of life questionnaire Mental Component Score (English language version) from baseline to 12 month following the Visualase procedure, categorized as -1 if the decrease is clinically significant (\<=-4.58), categorized as 0 if not clinically significant (-4.57 to +4.57), and categorized as +1 if the increase is clinically significant (\>=4.58). The SF-36 is a 36-item, patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The SF-36 Mental Component Score ranges from 0-100 with a higher score meaning a better outcome, on the assumption that each questions carries equal weight.
Change in SF-36 Physical Component Score Baseline and 12 Months Within-subject change of short form (SF)-36 quality of life questionnaire Physical Component Score (English language version) from baseline to 12 month following the Visualase procedure, categorized as -1 if the decrease is clinically significant (\<=-3.02), categorized as 0 if not clinically significant (-3.01 to +3.01), and categorized as +1 if the increase is clinically significant (\>=3.02). The SF-36 is a 36-item, patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The SF-36 Physical Component Scores range from 0-100 with a higher score meaning a better outcome, on the assumption that each questions carries equal weight.
Seizure Freedom Compared to Historical Controls (Open Surgical Resection) 12 Months Seizure freedom (Engel Class I) compared to historical control for open surgical resection.
It is hypothesized that the seizure freedom at 12 months following the Visualase procedure will not be inferior to 64% reported in the literature for open surgical resection.
An exact 95% CI for the percentage of subjects who are seizure free will be calculated and its lower boundary compared to zero after subtraction of the historical open surgical resection percentage of 64% and the addition of the equivalence delta percentage of 10%.
Trial Locations
- Locations (23)
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Stanford University
🇺🇸Palo Alto, California, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, 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
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
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of Washington Harborview
🇺🇸Seattle, Washington, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States