Completed

A Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients With Medically Refractory Partial Epilepsy

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Laser ablation

Procedure
Who is being recruted

Brain Diseases+1

+ Central Nervous System Diseases

+ Nervous System Diseases

From 18 to 75 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 2011
See protocol details

Summary

Principal SponsorMayo Clinic
Last updated: January 26, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2011

Actual date on which the first participant was enrolled.

In this study, we propose to evaluate a novel, thermal therapy and feedback system (Visualase® Thermal Therapy System) as an alternative to surgical resection for the treatment of focal lesional epilepsy in patients that are considered high risk surgical candidates. This system includes the FDA-cleared Visualase Cooled Laser Applicator System (VCLAS), which allows delivery of laser energy while the patient is being imaged by an MRI unit. The Visualase® System works via real-time MR thermal imaging (MRTI) to provide information on the thermal dose delivered to the target, resulting in a more precise and controlled delivery which has heretofore not been possible with previous non-image guided laser technology. We hypothesize that the Visualase system can be used in patients refractory to medication therapy in a minimally invasive procedure to destroy epileptogenic focal lesions in the brain.

NCT01703143
Principal SponsorMayo Clinic
Last updated: January 26, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpilepsy

Criteria

7 inclusion criteria required to participate
Age 18 years or older at entry to protocol
Candidate for resective epilepsy surgery
Considered healthy enough to undergo surgery with general anesthesia
Failure to respond to more than 2 anti-epileptic drugs at adequate dose and duration
Show More Criteria
5 exclusion criteria prevent from participating
Active Major depression
History of Non-Epileptic Behavioral Spells
History of Suicide attempts
Presence of a metallic prosthetic or implant including artificial hips, knees, joints, or rods and screws
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Laser ablation of focal lesions in patients with medically refractory partial epilepsy.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Mayo Clinic in Florida

Jacksonville, United StatesOpen Mayo Clinic in Florida in Google Maps

Mayo Clinic in Rochester

Rochester, United States
Completed2 Study Centers