MR-Guided Focused Ultrasound in the Treatment of Focal Epilepsy (EP001)

Epilepsy Clinical Trial

Official title: A Feasibility Study to Evaluate Safety and Initial Effectiveness of MR-Guided Focused Ultrasound Ablation Therapy in the Treatment of Focal Epilepsy

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness of Exablate thermal ablation of a focal epileptic target area in the brain of patients suffering from medication-refractory epilepsy, using the Exablate transcranial system to produce multiple sonications targeted in the focus of interest. The investigators will establish the feasibility and collect data to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy.

Clinical Trial Description

The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness of Exablate thermal ablation of a focal epileptic target area in the brain of patients suffering from medication-refractory epilepsy, using the Exablate transcranial system to produce multiple sonications targeted in the lesion of interest. The Investigators will establish the feasibility and collect data to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy.

The hypotheses tested are that:

1. MRgFUS treatment of focal epilepsy is feasible and safe, with a low risk of adverse effects as evaluated during the follow-up period.

2. Exablate treatment of foci in patients with focal epilepsy reduces the seizure frequency. ;

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy

• NCT number: NCT02804230
• Study type: Interventional
• Source: InSightec
• Contact: Nadir Alikacem
• Phone: +12146302000
• Email: nadira@insightec.com
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2016
• Completion date: June 30, 2023