Stereotactic Laser Ablation for Temporal Lobe Epilepsy

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

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 or bilateral hippocampal damage
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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Jamie VanGompel, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Jamie VanGompel, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials