Clinical Trial: Stereotactic Laser Ablation for Temporal Lobe Epilepsy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Stereotactic Laser Ablation for Temporal Lobe Epilepsy
Brief Summary: The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for mesial temporal epilepsy (MTLE).
Detailed Summary:
The purpose of the study is to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for necrotization or coagulation of epileptogenic foci in patients with intractable mesial temporal lobe epilepsy.
The study will include approximately 120 adult patients with drug-resistant MTLE treated at selected epilepsy centers across the United States. After the Visualase procedure, patients will be followed for 12 months and evaluated for freedom from seizures, quality of life, adverse events, and neuropsychological outcomes.
Sponsor: Medtronic Navigation, Inc.
Current Primary Outcome:
- Incidence of qualifying adverse events [ Time Frame: 12 months ]
- Seizure freedom, defined as Engel Classification of Postoperative Outcome Class I [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Seizure freedom compared to historical controls [ Time Frame: 12 months ]
- Seizure freedom, including subjects retreated with Visualase [ Time Frame: 12 months ]
- Change in Boston Naming Test scores [ Time Frame: Baseline and 12 months ]
- Change in Rey Auditory Verbal Learning Test scores [ Time Frame: Baseline and 12 months ]
- Change in Short Form-36 (SF-36) Health Survey scores [ Time Frame: Baseline and 12 months ]
- Change in Quality of Life in Epilepsy (QOLIE-31) scores [ Time Frame: Baseline and 12 months ]
Original Secondary Outcome: Same as current
Information By: Medtronic Surgical Technologies
Dates:
Date Received: July 15, 2016
Date Started: November 2016
Date Completion: October 2020
Last Updated: May 2, 2017
Last Verified: May 2017
