Stereotactic Laser Ablation for Temporal Lobe Epilepsy (Slate)

NCT02844465 | Completed Results DMC FDA Device

• 1 other identifier: CS-05000
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 23

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).

Conditions

Temporal Lobe Epilepsy

Keywords

epilepsy; laser ablation; Visualase; laser interstitial thermal therapy

Outcome Measures

Primary Outcomes (2)

• Incidence of Qualifying Adverse Events

  The incidence of qualifying device, procedure and/or anesthesia related adverse events. These events must also be moderate or severe and permanent for the following AEs: anxiety, aphasia, blurry vision, depression, diplopia, emotional lability, hemianopia, hemiparesis, memory impairment/difficulty, neurologic deficits, paralysis, psychological/psychiatric complications, quadrantanopia, sensory loss, sleep problems or insomnia. An exact 95% confidence interval (CI) will be calculated to determine if the upper bound of the CI for qualified AEs is less than 40%.

  12 months

• Seizure Freedom, Defined as Engel Classification of Postoperative Outcome Class I

  Seizure freedom at 12 months following the Visualase procedure (starting at 30 days post-procedure through 365 days post procedure). Engel Class I: Free of disabling seizures includes subclasses: A. Completely seizure free since surgery, B. Nondisabling simple partial seizures only since surgery, D. Generalized convulsions with antiepileptic drugs (AED) discontinuation only. An exact 95% CI will be calculated to determine if the lower bound of the CI for seizure freedom at 12 months following the Visualase procedure will be greater than 43%. Multiple imputation was used if subject diary data was not compliant. Retreated subjects are treated as failures.

  12 months

Secondary Outcomes (8)

• Seizure Freedom Compared to Historical Controls (Medical Therapy)

  12 months

• Seizure Freedom, Including Subjects Retreated With Visualase

  12 months

• Change in Boston Naming Test Scores

  Baseline and 12 months

• Change in Rey Auditory Verbal Learning Test Scores

  Baseline and 12 months

• Change in Quality of Life in Epilepsy (QOLIE-31) Scores

  Baseline and 12 months

Study Arms (1)

Treatment

EXPERIMENTAL

Visualase MRI-guided laser ablation procedure

Device: Visualase MRI-Guided Laser Ablation

Interventions

Visualase MRI-Guided Laser Ablation DEVICE

All subjects will undergo MRI-guided laser ablation of the amygdala and hippocampus with the Visualase System.

Also known as: Visualase System, Visualase procedure, Laser interstitial thermal therapy, Stereotactic laser ablation

Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (23)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92688, United States

Location

Stanford University

Palo Alto, California, 94305, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Rutgers University - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Northwell Health

Great Neck, New York, 11021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

Oregon Health & University Science

Portland, Oregon, 97239, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

University of Washington Harborview

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Epilepsy, Temporal Lobe; Epilepsy

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Results Point of Contact

• Title: Clinical Study Manager
• Organization: MedtronicNeuro

rs.slatestudy@medtronic.com

(877) 590-7835

Study Officials

• Robert Gross, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

• Michael Sperling, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 26, 2016
• Study Start: December 1, 2016
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: January 17, 2025
• Results First Posted: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)