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Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02844465
Recruitment Status : Recruiting
First Posted : July 26, 2016
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

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

Condition or disease Intervention/treatment Phase
Temporal Lobe Epilepsy Device: Visualase MRI-Guided Laser Ablation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Laser Ablation for Temporal Lobe Epilepsy
Actual Study Start Date : December 2016
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844465


Contacts
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Contact: Senior Clinical Research Manager rs.slatestudy@medtronic.com

Locations
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Sponsors and Collaborators
MedtronicNeuro
Investigators
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Principal Investigator: Robert Gross, MD, PhD Emory University
Principal Investigator: Michael Sperling, MD Thomas Jefferson University
More Information
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Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT02844465    
Other Study ID Numbers: CS-05000
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by MedtronicNeuro:
epilepsy
laser ablation
Visualase
laser interstitial thermal therapy
Additional relevant MeSH terms:
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Epilepsy
Epilepsy, Temporal Lobe
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Epilepsies, Partial
Epileptic Syndromes