High-Intensity Focused Ultrasound for Epilepsy
(HIFU for MRGE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method called high-intensity focused ultrasound (HIFU) to determine if it can safely reduce seizures in individuals with medication-resistant generalized epilepsy. HIFU uses sound waves, guided by MRI, to target and treat specific brain areas. The trial seeks participants who have experienced frequent seizures despite trying at least two different medications. Participants should not have any implanted devices incompatible with MRI scans. As an unphased trial, this study provides a unique opportunity to contribute to pioneering research that could lead to new treatment options for epilepsy.
What prior data suggests that MRI-guided high-intensity focused ultrasound (HIFU) is safe for treating medically refractory generalized epilepsy?
Research has shown that high-intensity focused ultrasound (HIFU) is generally safe for treating conditions like essential tremor and may also help with epilepsy. Previous studies found that patients tolerated HIFU well, with no serious side effects reported. Some patients have undergone HIFU without experiencing tissue damage or major side effects, suggesting that HIFU could be a safe option for treating seizures in epilepsy.
Since the FDA has already approved HIFU for essential tremor, it has passed strict safety tests for that condition. While this doesn't guarantee safety for epilepsy, it does offer some reassurance. Ongoing trials aim to confirm its safe use for generalized epilepsy as well.12345Why are researchers excited about this trial?
Researchers are excited about High-Intensity Focused Ultrasound (HIFU) for epilepsy because it offers a non-invasive alternative to more traditional options like medication or surgery. Unlike medications that often have broad effects on the brain, HIFU precisely targets specific areas involved in seizures without the need for incisions. This technique could potentially reduce side effects and recovery time compared to invasive surgical procedures. Additionally, HIFU's precise targeting might offer hope for patients who do not respond well to standard treatments, aiming for better seizure control with fewer adverse effects.
What evidence suggests that MRI-guided high-intensity focused ultrasound is effective for treating medically refractory generalized epilepsy?
Research has shown that High-Intensity Focused Ultrasound (HIFU) is already FDA-approved for treating essential tremor, demonstrating its ability to precisely target specific brain areas. This precision is crucial because it allows doctors to remove problematic brain tissue without damaging nearby healthy tissue. In this trial, participants will undergo HIFU treatment to target and reduce brain areas causing seizures. Although direct evidence on HIFU's effectiveness for epilepsy remains limited, its success in treating essential tremor suggests potential promise. The trial aims to determine if HIFU can reduce seizures in individuals whose epilepsy does not respond to medication. Early results from similar treatments have indicated that precise targeting can help control seizures, offering hope for new treatment options.678910
Who Is on the Research Team?
Ahmed Raslan, MD
Principal Investigator
Oregon Health and Science University
Are You a Good Fit for This Trial?
This trial is for adults aged 18 to 89 who have generalized epilepsy that hasn't improved with standard treatments. Participants should still be having seizures despite trying available medications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention 1
Unilateral HIFU treatment of the dominant hemisphere CMN
Follow-up
Safety follow-up visits to assess adverse events and seizure severity
Intervention 2
Second-side HIFU treatment of the CMN for eligible patients
Follow-up after Intervention 2
Additional follow-up for patients undergoing second-side treatment
What Are the Treatments Tested in This Trial?
Interventions
- High-Intensity Focused Ultrasound (HIFU)
Trial Overview
The study tests MRI-guided high-intensity focused ultrasound (HIFU), a non-invasive procedure using targeted sound waves to treat brain tissue linked to seizures, aiming to see if it safely reduces seizure frequency in people with hard-to-treat epilepsy.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
At the 1-year follow-up visit (for Intervention 1 - unilateral HIFU treatment of CMN), patients who have not experienced persistent clinically relevant AEs related to HIFU treatment, and who are not seizure-free according to the ILAE classification, will proceed to second-side HIFU treatment of the CMN (Intervention 2) after an additional three-month pre-second-side evaluation. Patients who are seizure-free according to the ILAE classification after unilateral treatment, or who develop clinically relevant adverse events (AEs) and any AEs related to HIFU treatment, will not undergo second-side treatment and will exit the study after the 1-year follow-up visit.
Ten patients will undergo unilateral HIFU treatment of the dominant hemisphere CMN (Intervention 1). Safety follow-up visits will take place at 2-weeks, 1-month, 3-months, 6-months, 9-months, and 1-year post-treatment to assess for persistent clinically relevant adverse events (AEs) and any AEs related to HIFU treatment. A seizure severity assessment will also be performed at these follow-up visits. Seizure freedom will be defined according to the ILAE classification, with only patients in ILAE classes 1 or 2 considered seizure-free. At the 1-year follow-up visit, patients who have not experienced persistent clinically relevant AEs related to HIFU treatment, and who are not seizure-free according to the ILAE classification, will proceed to second-side HIFU treatment of the CMN (Intervention 2) after an additional three-month pre-second-side evaluation. Patients who are seizure-free according to the ILAE classification after unilateral treatment, or who develop clinically relevant ad
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oregon Health and Science University
Lead Sponsor
InSightec
Industry Sponsor
Dr. Maurice R. Ferré
InSightec
Chief Executive Officer
MD
Dr. Arjun Desai
InSightec
Chief Medical Officer
MD
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