Feasibility Study on LITT for Medical Refractory Epilepsy

Sponsor

Monteris Medical (Industry)

Overall Status

Terminated

CT.gov ID

NCT02820740

Collaborator

(none)

Enrollment

Locations

Arm

26.1

Actual Duration (Months)

0.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

N/A

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 :

Apr 21, 2017

Actual Primary Completion Date :

Jun 24, 2019

Actual Study Completion Date :

Jun 24, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
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.
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 questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph's Hospital and Medical Center	Phoenix	Arizona	United States	85013
2	Yale University School of Medicine	New Haven	Connecticut	United States	06520
3	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
4	Mount Sinai West	New York	New York	United States	10019
5	Medical University of South Carolina	Charleston	South Carolina	United States	29425