N/A N=167 Treatment

Stereotactic Laser Ablation for Temporal Lobe Epilepsy (Slate)

Temporal Lobe Epilepsy

Bottom Line

View on ClinicalTrials.gov: NCT02844465 ↗

Enrolled (actual)

167

Serious AEs

9.6%

Results posted

Jan 2025

Primary outcome: Primary: Incidence of Qualifying Adverse Events — 7.9 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Visualase MRI-Guided Laser Ablation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: MedtronicNeuro
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Qualifying Adverse Events	7.9	—
PRIMARY Seizure Freedom, Defined as Engel Classification of Postoperative Outcome Class I	56.0	—
SECONDARY Seizure Freedom Compared to Historical Controls (Medical Therapy)	56.0	—
SECONDARY Seizure Freedom, Including Subjects Retreated With Visualase	56.0	—
SECONDARY Change in Boston Naming Test Scores	-0.1	<0.0001 sig
SECONDARY Change in Rey Auditory Verbal Learning Test Scores	-0.9	<0.0001 sig
SECONDARY Change in Quality of Life in Epilepsy (QOLIE-31) Scores	1; 54; 38	<0.0001 sig
SECONDARY Change in SF-36 Mental Component Score	13; 33; 39	0.0004 sig
SECONDARY Change in SF-36 Physical Component Score	12; 28; 44	<0.0001 sig
SECONDARY Seizure Freedom Compared to Historical Controls (Open Surgical Resection)	56.0	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02844465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.