Stereotactic Laser Ablation for Temporal Lobe Epilepsy (Slate)
United States167 participantsStarted 2016-12
Plain-language summary
The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for mesial temporal epilepsy (MTLE).
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
*…
What they're measuring
1
Incidence of Qualifying Adverse Events
Timeframe: 12 months
2
Seizure Freedom, Defined as Engel Classification of Postoperative Outcome Class I