Feasibility Study on LITT for Medical Refractory Epilepsy - Full Text View

Purpose

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	Intervention
Epilepsy	Device: NeuroBlate System


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment
Official Title:	Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Medical Refractory Epilepsy (FLARE)

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

U.S. FDA Resources

Further study details as provided by Monteris Medical:

Primary Outcome Measures:

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.
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:

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.
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.
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.


Estimated Enrollment:	45
Actual Study Start Date:	April 21, 2017
Estimated Study Completion Date:	December 2019
Estimated Primary Completion Date:	December 2019 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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 enter a Baseline (pre-surgery) Phase to establish their baseline seizure frequency. Subjects, or their caregivers, are required to keep a seizure diary throughout the study, beginning at the first baseline visit. The study will monitor and record subjects' seizure frequency, antiepileptic medications, and physical and emotional health.

Upon demonstrating the required seizure frequency and stable antiepileptic medications for the 3-Month Baseline Phase, subjects will qualify for the study procedure. 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.

Eligibility


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 3 or more complex partial seizures (with or without secondary generalization) per month
Refractory to antiepileptic drugs (AEDs). Subjects will be considered refractory if they have failed treatment with at least 2 AEDs due to lack of efficacy
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02820740

Contacts


Contact: Joan Hazen	(612) 345-4544	joan@brightresearchpartners.com
Contact: Audrey Singh	(763) 253-4717	asingh@monteris.com

Locations


United States, Kansas
University of Kansas Medical Center	Recruiting
Kansas City, Kansas, United States, 66160
Contact: Cathy Lauridsen 913-588-4580 clauridsen2@kumc.edu
Principal Investigator: Patrick Landazuri, MD

Sponsors and Collaborators

Monteris Medical

Investigators


Principal Investigator:	Dennis Spencer, MD	Yale University

More Information


Responsible Party:	Monteris Medical
ClinicalTrials.gov Identifier:	NCT02820740 History of Changes
Other Study ID Numbers:	FLARE
Study First Received:	June 8, 2016
Last Updated:	May 15, 2017


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

ClinicalTrials.gov processed this record on May 25, 2017