MR-Guided Focused Ultrasound in the Treatment of Subcortical Lesional Epilepsy (EP001)
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|ClinicalTrials.gov Identifier: NCT02804230|
Recruitment Status : Recruiting
First Posted : June 17, 2016
Last Update Posted : May 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy, Unspecified, Refractory (Medically)||Device: MRgFUS Ablation of Epileptic Foci||Not Applicable|
The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness of ExAblate thermal ablation of a subcortical 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:
- MRgFUS treatment of subcortical lesional epilepsy is feasible and safe, with a low risk of adverse effects as evaluated during the follow-up period.
- ExAblate treatment of subcortical lesions in patients with subcortical lesional epilepsy reduces the seizure frequency.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study to Evaluate Safety and Initial Effectiveness of MR-Guided Focused Ultrasound Ablation Therapy in the Treatment of Subcortical Lesional Epilepsy|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
Experimental: MRgFUS Ablation of Epileptic Foci
MR-Guided Focused Ultrasound
Device: MRgFUS Ablation of Epileptic Foci
MR-Guided Focused Ultrasound
- Severity of device and procedure related complications [ Time Frame: At the time of ExAblate Transcranial procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804230
|United States, Virginia|
|University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Stacy Thompson 434-982-4315 SRC2H@hscmail.mcc.virginia.edu|
|Principal Investigator: Nathan Fountain, MD|
|Principal Investigator:||Nathan Fountain, MD||University of Virginia|