Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser
ablation system for mesial temporal epilepsy (MTLE).
Phase
N/A
Funding Agency/Sponsor
Industry
Disease
Cranial
Enrollment Eligibility
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