← Back to Search

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

Disabling, medically refractory epilepsy (≥2 anti-epileptic drug failures)

Must not have

Post infectious epilepsy (post herpetic)

Primary generalized epilepsy (Lennox Gastaut, drop attacks)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

I have had 3 or more seizures a month in the last 3 months.

Select...

My epilepsy hasn't improved despite trying two different medications.

Select...

I experience seizures that start in one area and may spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have epilepsy caused by a previous herpes infection.

Select...

I have been diagnosed with a type of epilepsy that affects my whole brain.

Select...

I have fewer than 3 seizures a month.

Select...

I cannot or will not follow the drug plan for 3 months after treatment.

Select...

I do not have uncontrolled high blood pressure or other serious health issues.

Select...

I have had surgery to sever the connection between my brain's hemispheres.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Adverse Events

Number of Participants with Successful Lesion Creation

Secondary study objectives

Change MRI parameter (Water Diffusivity)

Change in Number of Seizures Reported Across Time

Total QOLIE-31-P Score Across Time

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 9Eligibility criteria met