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NCT02844465Completed

Stereotactic Laser Ablation for Temporal Lobe Epilepsy (Slate)

Stereotactic Laser Ablation for Temporal Lobe Epilepsy

Source: ClinicalTrials.gov · Last updated 17 Jan 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Interventional
Enrollment
167 (actual)
First submitted
15 Jul 2016
Start date
Dec 2016
Primary completion date
11 Dec 2023
Lead sponsor
MedtronicNeuro
Diseases
Epilepsy
NCT number
NCT02844465

What you commit to

  • Study type: Interventional
  • Participants enrolled: 167
  • From Dec 2016 to the primary completion date, 11 Dec 2023
  • 23 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of previous intracranial surgery for treatment of epileptic seizures

Other illness

  • Progressive brain lesions and/or tumors not associated with epileptic disease state
  • Seizures with contralateral or extra-temporal ictal onset on EEG
  • If additional testing has been performed, results are discordant with the seizure focus scheduled for ablation
  • 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
  • Allergy to gadolinium

Other

  • 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
  • Persistent extra-temporal or predominant contralateral focal interictal spikes or slowing, or generalized interictal spikes 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
  • Non-compliance with AED requirements
  • IQ \< 70
  • Participation in other research that may potentially interfere with SLATE endpoint(s)

Who the study is looking for

  • 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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emory University
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AtlantaUnited StatesUnknown status
University of Colorado Anschutz Medical Campus
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AuroraUnited StatesUnknown status
Johns Hopkins University
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BaltimoreUnited StatesUnknown status
University of Virginia
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CharlottesvilleUnited StatesUnknown status
University of Chicago
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ChicagoUnited StatesUnknown status
Ohio Health Research Institute
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ColumbusUnited StatesUnknown status
Henry Ford Health System
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DetroitUnited StatesUnknown status
Northwell Health
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Great NeckUnited StatesUnknown status
The University of Texas Health Science Center at Houston
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HoustonUnited StatesUnknown status
Indiana University
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IndianapolisUnited StatesUnknown status
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesUnknown status
University of Louisville Hospital
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LouisvilleUnited StatesUnknown status
University of Miami
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MiamiUnited StatesUnknown status
Rutgers University - Robert Wood Johnson Medical School
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New BrunswickUnited StatesUnknown status
Hoag Memorial Hospital Presbyterian
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Newport BeachUnited StatesUnknown status
Columbia University Medical Center
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New YorkUnited StatesUnknown status
Stanford University
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Palo AltoUnited StatesUnknown status
Thomas Jefferson University
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PhiladelphiaUnited StatesUnknown status
Oregon Health & University Science
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PortlandUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status
University of Washington Harborview
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SeattleUnited StatesUnknown status
Wake Forest Baptist Health
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Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.