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A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
Sponsor: University of North Carolina, Chapel Hill
Summary
The purpose of this study is to assess the safety and feasibility of unilateral focused ultrasound thalamotomy in adults with focal onset epilepsy whose medicines are not working well. The ExAblate (ExAblate) transcranial system is the name of the device that will be used to create and send ultrasound waves through the scalp and skull precisely to a small structure located in the center of the brain. This structure is known as the "Anterior Nucleus", and is an important region in the brain that may cause seizures. Safety will be measured by recording and analyzing the frequency of side effects throughout participation. Feasibility will be measured by the ability to create a lesion in the anterior nucleus.
Official title: A Pilot Open-label Clinical Trial Evaluating the ExAblate Model 4000 Type-1 Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2018-04-24
Completion Date
2028-05
Last Updated
2025-08-15
Healthy Volunteers
No
Conditions
Interventions
High Intensity Focused Ultrasound
Participants will undergo high intensity focused ultrasound surgery utilizing magnetic resonance (MR) imaging guidance using a 3 Tesla scanner.
Locations (1)
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States