RecruitingPhase 1NCT05032105

The Impact of Focused Ultrasound Thalamotomy of the Anterior Nucleus for Focal-Onset Epilepsy on Anxiety

.An Open-label Clinical Trial Evaluating the ExAblate Model 4000 Type-1 Focused Ultrasound Unilateral Thalamotomy for Patients with Treatment-refractory Focal Onset Epilepsy and Comorbid Anxiety.


Sponsor

Ohio State University

Enrollment

10 participants

Start Date

Jun 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the feasibility, safety, and effects on anxiety of high intensity focused ultrasound ablation (FUSA) in patients suffering from treatment-refractory focal epilepsy and anxiety. FUSA is a non-invasive neurosurgical procedure that uses ultrasound waves, sent directly through the scalp and skull, to precisely target small abnormal areas of the brain. For this study, the targeted area of the brain is the anterior nucleus of the thalamus. This brain region may cause seizures and may also be involved in anxiety. The study will test if FUSA is safe and tolerated, and if it reduces anxiety and brain response to threat in patients with anxiety receiving the procedure for partial-onset epilepsy that is resistant to medications.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial studies whether focused ultrasound — a non-invasive brain treatment that uses sound waves to precisely target a brain region called the anterior nucleus of the thalamus — can reduce anxiety in people with drug-resistant epilepsy. Patients already qualify for this procedure for seizure control; this study adds assessments of anxiety before and after. **You may be eligible if...** - You have epilepsy that has not responded to at least 2 anti-seizure medications - You have at least 3 seizures per month on average - Your seizures start in a specific brain area (focal onset) and may spread - You have moderate-to-severe anxiety (HAM-A score above 17) - Your medications have been stable for at least 3 months - You have had a recent comprehensive epilepsy workup including EEG and MRI **You may NOT be eligible if...** - You have fewer than 3 seizures per month - You have purely generalized epilepsy (such as Lennox-Gastaut syndrome) - Your target brain area cannot be identified on MRI - You have other serious medical or psychiatric conditions that interfere with participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMagnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA)

Unilateral Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) of the anterior nucleus of the thalamus (ATN)


Locations(1)

The Ohio State University

Columbus, Ohio, United States

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NCT05032105


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