Stereotactic Laser Ablation for Temporal Lobe Epilepsy
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-005273
NCT ID: NCT02844465
Sponsor Protocol Number: CS-05000
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 |
|
More information
Publications
Publications are currently not available