Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment
Visualase MRI-guided laser ablation procedure
  • Device: Visualase MRI-Guided Laser Ablation
    All subjects will undergo MRI-guided laser ablation of the amygdala and hippocampus with the Visualase System.
    Other names:
    • Visualase System
    • Visualase procedure
    • Laser interstitial thermal therapy
    • Stereotactic laser ablation

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Jessica A. Johnson, MSN, NP-C
713-500-5443
Jessica.A.Johnson@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
Medtronic Navigation, Inc.

Study Contact

Guy Alvarez, PhD
rs.slatestudy@medtronic.com

Detailed Description

The purpose of the study is to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for necrotization or coagulation of epileptogenic foci in patients with intractable mesial temporal lobe epilepsy.

The study will include approximately 150 adult patients with drug-resistant MTLE treated at selected epilepsy centers across the United States. After the Visualase procedure, patients will be followed for 12 months and evaluated for freedom from seizures, quality of life, adverse events, and neuropsychological outcomes.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.