A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
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|ClinicalTrials.gov Identifier: NCT03417297|
Recruitment Status : Available
First Posted : January 31, 2018
Last Update Posted : February 6, 2018
|Condition or disease||Intervention/treatment|
|Partial Seizures With Secondary Generalization||Device: high intensity focused ultrasound|
This is a open-label prospective intervention study. Ten (10) adults with refractory, partial-onset epilepsy with secondary generalization and able to provide informed consent will be enrolled. In addition to the diagnosis of medically refractory epilepsy, these patients will need to meet protocol specific inclusion and exclusion criteria. These adults will be screened from the patients being cared for by the epilepsy program at The Ohio State University or referred from elsewhere for enrollment in the study. Initially, 3 participants will be enrolled and followed for 3 months to assess the safety of study intervention. Pending review by the Data and Safety Monitoring Committee (DSMC), an additional 7 participants will be enrolled.
This pilot study is being conducted to test this feasibility of this device in order to confirm the design and operating specifications of the device including the ability to identify, and accurately ablate the target focus within the Anterior Nucleus.
Safety will be assessed by the absence of side effects, e.g. new onset of neurological deficits, performance deterioration on neuropsychological testing. Feasibility is defined as the ability to create the desired lesion within the anterior nucleus.
Seizure frequency data will be collected by seizure diary. Quality of life will be measured by the Quality of Life in Epilepsy Inventory -31. Imaging analysis will include study of changes in resting state functional connectivity (assessed by fMRI), as well as in structural (assessed by volumetric T1 and T2 weighted imaging) and microstructural (assessed by diffusion tensor imaging) brain anatomy.
|Study Type :||Expanded Access|
|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|
Device: high intensity focused ultrasound
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): NCT03417297
|Contact: Carson R Reider, PhDemail@example.com|
|Contact: Angela S Emerson, MPHfirstname.lastname@example.org|