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

Conditions

• Idiopathic Generalized Epilepsy

Eligibility Criteria

Sex

ALL

Age

18 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

• Intervention 1 — DEVICE
  HIFU ablation of dominant-hemisphere centromedian thalamic nucleus (CMN), or dominant seizure activity hemisphere
• Intervention 2 — DEVICE
  HIFU ablation of contralateral centromedian thalamic nucleus (CMN)

Study Details

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.

Key Dates

First listed

Sep 4, 2026

Start date

Feb 28, 2027

Status verified

Jul 2026

Primary completion

Dec 31, 2030

Completion

Jun 30, 2031

Study Design

Enrollment

10 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Intervention 1
  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
• Experimental: Intervention 2
  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.

Primary Outcome Measure

Primary Aim 1 [ Time Frame: From enrollment to 1 year following treatment ]

Central Contacts

• Michael McGehee, MS
  971-509-4932
  [email protected]

Locations (1)

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