Feasibility Study on LITT for Medical Refractory Epilepsy

Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Medical Refractory Epilepsy (FLARE)

Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System for the treatment of drug-refractory medial temporal lobe epilepsy in subjects who are candidates for LITT surgery.

Study Overview

• Status: Terminated
• Conditions: Epilepsy
• Intervention / Treatment: Device: NeuroBlate System

Detailed Description

Monteris is sponsoring this multicenter, open-label, prospective feasibility study to characterize the performance of laser interstitial thermal therapy (LITT) using the Monteris NeuroBlate System for the treatment of drug-refractory medial temporal lobe epilepsy in subjects who are candidates for LITT surgery.

The NeuroBlate System uses precise, high-intensity laser light to initiate necrosis of abnormal brain tissue through thermal ablation while limiting injury to healthy tissue. Unlike traditional brain surgery, LITT does not require a large opening in the skull.

Subjects who meet the study eligibility criteria and sign the informed consent form will undergo the LITT procedure. Subjects, or their caregivers, are required to keep a seizure diary throughout the study, beginning after surgery. The study will monitor and record subjects' seizure frequency, antiepileptic medications, and physical and emotional health.

Subjects treated with NeuroBlate will have 2 years of follow-up. Throughout study participation, the study investigator will continuously monitor and document both effectiveness and safety data at study appointments.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital and Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • New York
    • New York, New York, United States, 10019
      • Mount Sinai West
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Relevant Inclusion Criteria are listed below

• Diagnosis of unilateral medial temporal lobe epilepsy (MTLE) confirmed clinically and with either (1) ictal scalp recording and MRI evidence of mesial temporal sclerosis or (2) intracranial ictal onset consistent with hippocampal origin
• Averages 1 or more complex partial seizures or secondary generalized seizures compatible with MTLE per month
• On stable antiepileptic medications
• Meets the criteria for a medial temporal lobe resection and is a candidate for LITT
• 18 years or older at the time of consent

Relevant Exclusion Criteria are listed below

• Previous diagnosis of psychogenic/non-epileptic seizures
• Previous diagnosis of primary generalized seizures
• IQ less than 70
• Subject has a MRI-incompatible implanted electronic device or any metallic prosthesis or implant for which brain MRI is contraindicated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: NeuroBlate LITT Treatment; This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System.	Device: NeuroBlate System; Laser Interstitial Thermal Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	Characterize adverse events experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Adverse events will be collected based on subject reports and subject examination/testing.	2 Years
Changes in Neuropsychological Functioning	Characterize changes to neuropsychological functioning experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Descriptive statistics (via neuropsychological assessment tools) will be reported for the measured score at baseline and each follow-up visit.	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Seizure Frequency	Characterize changes in seizure frequency experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System by utilizing patient diary to evaluate seizure occurrences.	2 Years
Surgical Outcome Classification	Characterize the Engel and ILAE surgical outcome classification in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Classifications will be determined by the Investigator. Engel Scale Class I: Free of disabling seizures Class II: Rare disabling seizures Class III: Worthwhile improvement Class IV: No worthwhile improvement ILAE Outcome Scale Class 1: Completely seizure free; no auras Class 2: Only auras; no other seizures Class 3: 1 to 3 seizure days per year; ± auras Class 4: 4 seizure days per year to 50% reduction of baseline seizure days; ± auras Class 5: Less than 50% reduction of baseline seizure days; ± auras Class 6: More than 100% increase of baseline seizure days; ± auras	2 Years
Changes in Quality of Life	Characterize the changes in quality of life in subjects with medical temporal lobe epilepsy undergoing LITT using the NeuroBlate System. Quality of life will be measured using the QOLIE-31 (Quality of Life in Epilepsy) questionnaire. Score scale 0-100 with 100 indicating a higher reported quality of life across seven different categories (seizure worry, overall quality of life, social functioning, emotional wellbeing, medication effects, energy/fatigue, and cognitive functioning).	2 Years

Collaborators and Investigators

• Sponsor: Monteris Medical
• Investigators: Principal Investigator: Dennis Spencer, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2017
• Primary Completion (Actual): June 24, 2019
• Study Completion (Actual): June 24, 2019

Study Registration Dates

• First Submitted: June 8, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimated): July 1, 2016

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Epilepsy; Quality of Life; Seizure; LITT; Medial Temporal Lobe Epilepsy; NeuroBlate
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: FLARE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes