Clinical trial NCT02820740: Feasibility Study on LITT for Medical Refractory Epilepsy
Official title: Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Medical Refractory Epilepsy (FLARE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Epilepsy
Keywords: Epilepsy
Medial Temporal Lobe Epilepsy
Seizure
NeuroBlate
LITT
Quality of Life
Lead sponsor: Monteris Medical
Sponsor class: INDUSTRY
First posted: 2016-07-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 2 Years
measure: Changes in Neuropsychological Functioning
timeFrame: 1 Year
Secondary outcomes:
measure: Changes in Seizure Frequency
timeFrame: 2 Years
measure: Surgical Outcome Classification
timeFrame: 2 Years
measure: Changes in Quality of Life
timeFrame: 2 Years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New York
country: United States
facility: Mount Sinai West
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Yale University
name: Dennis Spencer, MD
role: PRINCIPAL_INVESTIGATOR
References: