Feasibility Study on LITT for Medical Refractory Epilepsy

Not Applicable

Terminated

• Conditions: Epilepsy
• Interventions: Device: NeuroBlate System

• Registration Number: NCT02820740
• Lead Sponsor: Monteris Medical

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.

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 Timeline

• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-07-01
• Study Start: 2017-04-21
• Primary Completion: 2019-06-24
• Study Completion: 2019-06-24
• Results First Submitted: 2023-05-04
• Status Verified: 2024-05
• Results First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-11
• Results First Posted: 2024-07-12
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NeuroBlate LITT Treatment	NeuroBlate System	This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	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.
Changes in Neuropsychological Functioning	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

Name	Time	Method
Changes in Seizure Frequency	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.
Changes in Quality of Life	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 (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).
Surgical Outcome Classification	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.; 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

Trial Locations

Locations (5)

Mount Sinai West; 🇺🇸 New York, New York, United States

St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States