NCT02804230

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DEVICE	Neuro Ablation - Functional	MR-Guided Focused Ultrasound

Timeline

• Start date: 2016-06-07
• Primary completion: 2023-06-23
• Completion: 2023-06-30
• First posted: 2016-06-17
• Last updated: 2022-09-10

Locations

4 sites across 1 country: United States