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High-Intensity Focused Ultrasonic Ablation of the Centromedian Thalamic Nucleus for Treatment of Medically Refractory Generalized Epilepsy in Patients Ages 18 Years to 89 Years

NCT07803692 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-09-04

No results posted yet for this study

Summary

The purpose of this study is to find out if magnetic resonance (MRI)-guided high-intensity focused ultrasound (HIFU) is safe and effective for treating medically refractory generalized epilepsy. HIFU is a procedure that delivers ultrasonic waves to brain regions with great precision to remove tissue that may cause problems. HIFU is approved by the Federal Drug Administration (FDA) for treating patients with essential tremor.

This study aims to find out if HIFU can safely reduce seizure burden in patients with medically refractory generalized epilepsy (MRGE) using metrics commonly used in other treatments for epilepsy, and by the change in frequency of convulsive (generalized tonic-clonic) seizures before and after the intervention.

Conditions

  • Idiopathic Generalized Epilepsy

Interventions

DEVICE

Intervention 1

HIFU ablation of dominant-hemisphere centromedian thalamic nucleus (CMN), or dominant seizure activity hemisphere

DEVICE

Intervention 2

HIFU ablation of contralateral centromedian thalamic nucleus (CMN)

Sponsors & Collaborators

  • InSightec

    collaborator INDUSTRY

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Ahmed Raslan, MD · Oregon Health and Science University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-02-28
Primary Completion
2030-12-31
Completion
2031-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07803692 on ClinicalTrials.gov