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Procedure
Focused Ultrasound for Epilepsy
N/A
Recruiting
Led By Vibhor Krishna, MD SM
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥ 3 seizures/month on average within 3 months of enrollment
Stable medication dosage for 3 months before enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will test whether MRgFUS is a safe and feasible option for patients with epilepsy who are not responding well to medication.
Who is the study for?
This trial is for people with epilepsy whose seizures aren't controlled by medication. They must have focal onset seizures that can generalize, no recent substance abuse, and a stable medication dose for the last 3 months. Participants need an identifiable Anterior Nucleus on MRI, agree to keep a seizure diary, and not be pregnant or using ineffective birth control.Check my eligibility
What is being tested?
The study tests the safety of using focused ultrasound (MRgFUS) to target the brain's Anterior Nucleus in patients with epilepsy. The ExAblate transcranial system delivers these waves non-invasively through the skull to potentially prevent seizures.See study design
What are the potential side effects?
Possible side effects include discomfort from scalp heating during treatment, headaches post-procedure, nausea or dizziness. There may also be risks associated with exposure to high-intensity sound waves in sensitive brain tissue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had 3 or more seizures a month in the last 3 months.
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My medication doses have been the same for the last 3 months.
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My epilepsy hasn't improved despite trying two different medications.
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I experience seizures that start in one area and may spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Adverse Events
Number of Participants with Successful Lesion Creation
Secondary outcome measures
Change MRI parameter (Water Diffusivity)
Change in Number of Seizures Reported Across Time
Total QOLIE-31-P Score Across Time
Trial Design
1Treatment groups
Experimental Treatment
Group I: high intensity focused ultrasoundExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High Intensity Focused Ultrasound
2006
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
823 Previous Clinical Trials
501,239 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,500 Previous Clinical Trials
4,186,714 Total Patients Enrolled
Focused Ultrasound FoundationOTHER
14 Previous Clinical Trials
300 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a bad reaction to IV dye or contrasting agents in the past.Your score on a specific test for thinking and problem-solving is less than 70.The MRI shows that the Anterior Nucleus (AN) can be seen clearly on the pictures.I have epilepsy caused by a previous herpes infection.You have had a vagal nerve stimulator implanted before.You have serious mental health problems that are not being treated.You have used drugs or alcohol heavily in the recent past.I have had 3 or more seizures a month in the last 3 months.My medication doses have been the same for the last 3 months.I have been diagnosed with a type of epilepsy that affects my whole brain.My epilepsy hasn't improved despite trying two different medications.I experience seizures that start in one area and may spread.I have fewer than 3 seizures a month.I cannot or will not follow the drug plan for 3 months after treatment.I do not have uncontrolled high blood pressure or other serious health issues.You have had a test to check for seizures within the past 12 months, such as a home EEG, video EEG, or intracranial EEG.I have had surgery to sever the connection between my brain's hemispheres.You have major problems in your brain structure.You have a history of feeling very uncomfortable in small, enclosed spaces.The ratio of skull density is less than 0.4.You have metal or medical devices in your body that can't be in the MRI machine.You need to have a high-quality MRI or PET scan.You need to take a test to see how well your brain is working. If you score 70 or higher on the test, you can join the study.
Research Study Groups:
This trial has the following groups:- Group 1: high intensity focused ultrasound
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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