Ensayos clínicos

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