Feasibility Study on LITT for Medical Refractory Epilepsy

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Epilepsy	Device: NeuroBlate System	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Medical Refractory Epilepsy (FLARE)
Actual Study Start Date :	April 21, 2017
Estimated Primary Completion Date :	December 2019
Estimated Study Completion Date :	December 2019

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Adverse events [ Time Frame: 2 Years ]
   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. Changes in neuropsychological functioning [ Time Frame: 1 Year ]
   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.

Secondary Outcome Measures :

1. Changes in seizure frequency [ Time Frame: 2 Years ]
   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. Surgical outcome classification [ Time Frame: 2 Years ]
   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.
3. Changes in quality of life [ Time Frame: 2 Years ]
   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 questionnaire.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Monteris Medical

Investigators

Principal Investigator:	Dennis Spencer, MD	Yale University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Monteris Medical
ClinicalTrials.gov Identifier:	NCT02820740 History of Changes
Other Study ID Numbers:	FLARE
First Posted:	July 1, 2016
Last Update Posted:	March 22, 2018
Last Verified:	March 2018

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		Yes
Device Product Not Approved or Cleared by U.S. FDA:		No
Pediatric Postmarket Surveillance of a Device Product:		No

Keywords provided by Monteris Medical:

Epilepsy; Medial Temporal Lobe Epilepsy; Seizure	NeuroBlate; LITT; Quality of Life

Additional relevant MeSH terms:

Epilepsy; Drug Resistant Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases