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Trial record 2 of 3 for:    slate

Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Medtronic Surgical Technologies
Sponsor:
Information provided by (Responsible Party):
Medtronic Surgical Technologies ( Medtronic Navigation, Inc. )
ClinicalTrials.gov Identifier:
NCT02844465
First received: July 15, 2016
Last updated: January 23, 2017
Last verified: January 2017
  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 Intervention
Temporal Lobe Epilepsy
Device: Visualase MRI-Guided Laser Ablation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Stereotactic Laser Ablation for Temporal Lobe Epilepsy

Resource links provided by NLM:


Further study details as provided by Medtronic Surgical Technologies:

Primary Outcome Measures:
  • Incidence of qualifying adverse events [ Time Frame: 12 months ]
  • Seizure freedom, defined as Engel Classification of Postoperative Outcome Class I [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Seizure freedom compared to historical controls [ Time Frame: 12 months ]
  • Seizure freedom, including subjects retreated with Visualase [ Time Frame: 12 months ]
  • Change in Boston Naming Test scores [ Time Frame: Baseline and 12 months ]
  • Change in Rey Auditory Verbal Learning Test scores [ Time Frame: Baseline and 12 months ]
  • Change in Short Form-36 (SF-36) Health Survey scores [ Time Frame: Baseline and 12 months ]
  • Change in Quality of Life in Epilepsy (QOLIE-31) scores [ Time Frame: Baseline and 12 months ]

Estimated Enrollment: 120
Study Start Date: November 2016
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 120 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02844465

Contacts
Contact: Guy Alvarez, PhD rs.slatestudy@medtronic.com

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Letitia Fisher    305-243-7108    lfisher@med.miami.edu   
Principal Investigator: Jonathan Jagid, MD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Lisa Scarpace    313-916-2360    LSCARPA1@hfhs.org   
Principal Investigator: Jason Schwalb, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Karla Crockett    507-538-9140    crockett.karla@mayo.edu   
Principal Investigator: Jamie Van Gompel, MD         
United States, New York
Northwell Health Recruiting
Great Neck, New York, United States, 11021
Contact: Connie Lau    516-325-7022    clau@northwell.edu   
Principal Investigator: Ashesh D Mehta, MD, PhD         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Liz Fletman    215-955-4673    elizabeth.fletman@jefferson.edu   
Principal Investigator: Michael Sperling, MD         
Sponsors and Collaborators
Medtronic Navigation, Inc.
Investigators
Principal Investigator: Robert Gross, MD, PhD Emory University
Principal Investigator: Michael Sperling, MD Thomas Jefferson University
  More Information

Responsible Party: Medtronic Navigation, Inc.
ClinicalTrials.gov Identifier: NCT02844465     History of Changes
Other Study ID Numbers: CS-05000
Study First Received: July 15, 2016
Last Updated: January 23, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: There is not a plan to share individual participant data, but aggregate data for all primary and secondary endpoints will be shared.

Keywords provided by Medtronic Surgical Technologies:
epilepsy
laser ablation
Visualase
laser interstitial thermal therapy

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Temporal Lobe
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial

ClinicalTrials.gov processed this record on April 27, 2017