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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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

MRgFUS (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03417297 — N/A
Partial Seizures Research Study Groups: high intensity focused ultrasound
Partial Seizures Clinical Trial 2023: MRgFUS Highlights & Side Effects. Trial Name: NCT03417297 — N/A
MRgFUS (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03417297 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby May 2025