Stereotactic Laser Ablation for Temporal Lobe Epilepsy



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 70
Updated:3/3/2019
Start Date:December 2016
End Date:May 2022
Contact:Guy Alvarez, PhD
Email:rs.slatestudy@medtronic.com

Use our guide to learn which trials are right for you!

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

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.

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
We found this trial at
17
sites
Detroit, Michigan 48202
Principal Investigator: Jason Schwalb, MD
Phone: 313-916-1102
?
mi
from
Detroit, MI
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: John T. Willie, MD, PhD
Phone: 404-778-7673
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Joon-Yi Kang, MD
Phone: 415-502-0965
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Peter C. Warnke, MD
Phone: 773-702-1096
University of Chicago One of the world's premier academic and research institutions, the University of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Nitin Tandon, MD
Phone: 713-500-5443
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
?
mi
from
Houston, TX
Click here to add this to my saved trials
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Vicenta Salanova, MD
Phone: 317-963-7440
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Jonathan Jagid, MD
Phone: 305-243-7108
University of Miami A private research university with more than 15,000 students from around the...
?
mi
from
Miami, FL
Click here to add this to my saved trials
13001 E 17th Pl
Aurora, Colorado 80045
(303) 724-5000
Principal Investigator: Aviva Abosch, MD, PhD
Phone: 303-724-4134
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Great Neck, New York 11021
Principal Investigator: Ashesh D Mehta, MD, PhD
Phone: 516-297-0864
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
675 Hoes Lane West
New Brunswick, New Jersey 08901
Principal Investigator: Stephen Wong, MD
Phone: 732-235-7342
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Guy M. McKhann II, MD
Phone: 212-305-1038
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
?
mi
from
New York, NY
Click here to add this to my saved trials
Palo Alto, California 94304
Principal Investigator: Casey Halpern, MD
Phone: 650-721-2830
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Michael Sperling, MD
Phone: 215-503-3213
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Rochester, Minnesota 55905
Principal Investigator: Jamie Van Gompel, MD
Phone: 507-538-9140
?
mi
from
Rochester, MN
Click here to add this to my saved trials
San Francisco, California 94143
Principal Investigator: Robert Knowlton, MD
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Seattle, Washington 98104
Principal Investigator: John W. Miller, MD, PhD
Phone: 206-744-3624
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
Principal Investigator: Gautam Popli, MD
Phone: 336-716-8694
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials