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 : Recruiting
First Posted : January 31, 2018
Last Update Posted : April 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Partial Seizures With Secondary Generalization||Device: high intensity focused ultrasound||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a pilot study. There are no statistical testing. Ten (10) adults with refractory, partial-onset epilepsy with secondary generalization and able to provide informed consent will be enrolled. 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) and the US Food and Drug Administration (FDA), an additional 7 participants will be enrolled.|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|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|
|Actual Study Start Date :||April 24, 2018|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||February 28, 2021|
Experimental: high intensity focused ultrasound
Initially, 3 patients will be enrolled and followed for 3 months to assess the safety of study intervention which is unilateral MR guides focused ultrasound thalamotomy (anterior nucleus). These data will be reviewed by the Data and Safety Monitoring Committee (DSMC) and the FDA. If approval is granted by the DSMC and FDA, then up to an additional 7 participants will be enrolled.
Device: high intensity focused ultrasound
high intensity focused ultrasound
Other Name: ExAblate Model 4000 Type-1 focused ultrasound
- Feasibility [ Time Frame: during the surgical procedure ]development of altered mental status (not explained by the administration of routine anesthetic or pain medications) or severe neurological deficits (e.g. weakness/numbness/tingling in arms or legs, or aphasia)
- Safety [ Time Frame: 12 months ]Neuropsychological determination of cause for suspension/termination will 2 include detection of statistically and clinically meaningful decline among 2 of the initial 3 subjects enrolled; else among 4 of the total 10 subjects expected to be enrolled. This is determined through reliable change index analysis comparing raw subject performance scores in language, memory, and executive function domains with existing data published in test manuals to determine whether 3-month performance represents a clinically and statistically meaningful decline in at least two measures in one of these domains. We intend to use the McSweeny et al. RCI model.
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: Angela S Emerson, MPHemail@example.com|
|Contact: Carson R Reider, PhDfirstname.lastname@example.org|
|United States, Ohio|
|The Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Angela S Emerson, MPH 614-685-3141 email@example.com|
|Principal Investigator:||Vibhor Krishna, MD SM||Ohio State University|